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The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to 80601-2-56:2017 + A1 2018.
This study is designed to provide supporting documentation for the TIMMY3 module operating with SureTemp Plus algorithms. Testing will be performed with a production equivalent CVSM modified to use TIMMY3 (TIMMY3 investigational device), running the SureTemp Plus algorithms. The TIMMY3 module is intended to be integrated into additional Welch Allyn devices such as, but not limited to, the Connex Spot Monitor and Spot 4400. The process described below will be followed in accordance with the method called out in ISO 80601-2-56:2017 + A1:2018.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Temperature Measurement | Experimental | Febrile and non-febrile subjects aged 5 years or older. |
|
| Pediatric Axillary Temperature Measurement | Experimental | Febrile and non-febrile pediatric subjects <1 year to <18 years. |
|
| Adult Axillary Temperature Measurement | Experimental | Febrile and non-febrile adult subjects >= 18 years old. |
|
| Rectal Temperature Measurement | Experimental | Febrile and non-febrile adult and pediatric subjects newborn and older. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connex CVSM with Timmy3 module | Device | Connex Vital Signs Monitor with the Timmy3 Investigational module |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Clinical Bias |
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Inclusion Criteria:
Study subjects (person who is having their temperature taken) must meet the following criteria to participate in this study:
Exclusion Criteria:
Study subjects (person who is having their temperature taken) are excluded if they meet any of the below criteria. Any subject that withdraws from the study will be replaced.
Note: The study subject will be excluded if the reference temperature does not stabilize after the 3 -5 minute monitoring time.
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| Name | Affiliation | Role |
|---|---|---|
| Eric Fernandez, M.D. | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Georgia Physicians Group | Fayetteville | Georgia | 30214 | United States | ||
| Mankato Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Subjects | All subjects who signed informed consent. Subjects could be included in one or more ISO analysis sets. ISO 80601-2-56:2017+A1:2018 required limiting analysis to the first 105 subjects per mode (oral, rectal, pediatric axillary, adult axillary) who met age and febrile distribution criteria. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are reported for subjects in at least one ISO-compliant analysis set (N=281). Although 373 enrolled and 369 completed, ISO 80601-2-56:2017+A1:2018 required limiting analysis to the first 105 subjects per mode (oral, rectal, pediatric axillary, adult axillary) meeting age and febrile criteria. Some subjects participated in multiple modes, so totals across sets do not equal unique subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | ISO Analysis Sets | All enrolled subjects who had an ISO compliant data set collected. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Mean | Standard Deviation | degree Celsius | 20-30 minutes |
|
Baseline to approximately 20 to 30 minutes after consent; no follow-up was required.
There were no safety objectives and endpoints, and no adverse events were reported in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ISO Analysis Sets | Includes all subjects who underwent measurement using TIMMY3 temperature module, regardless of whether a temperature measurement was obtained (Safety Analysis Set) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Baxter Clinical Trials Disclosure Call Center | Baxter Healthcare | (224) 948-7359 | Global_CORP_ClinicalTrialsDisclosure@baxter.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 11, 2024 | Dec 9, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2025 | Nov 6, 2025 | SAP_001.pdf |
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Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]).
| 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | 20-30 minutes |
| Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm - Clinical Repeatability | Clinical repeatability is defined per ISO 80601-2-56:2017 + A1:2018 as the pooled within-subject standard deviation (SD) of triplicate device-under-test output temperatures for each anatomical site (refer to ISO formulas [5] and [6]). This outcome reports that SD as a single numeric value (°C); because it is a dispersion statistic (not a mean), no central-tendency measure applies. Higher SD indicates lower repeatability. | 20-30 minutes |
| Mankato |
| Minnesota |
| 56001 |
| United States |
| John R. Oishei Children's Hospital | Buffalo | New York | 14203 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Forest Lane Pediatrics | Dallas | Texas | 75230 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mode(s) of Thermometry Consented to | Subjects may have consented to more than one mode of thermometry. | Count of Participants | Participants |
|
| Febrile Status - Oral | Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed. | Count of Participants | Participants |
|
| Febrile Status - Axillary Pediatric | Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed. | Count of Participants | Participants |
|
| Febrile Status - Axillary Adult | Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed. | Count of Participants | Participants |
|
| Febrile Status - Rectal | Febrile status was evaluated only for subjects included in the ISO-compliant analysis set for this mode. Per ISO 80601-2-56:2017+A1:2018, each temperature mode required 105 subjects meeting age and febrile distribution criteria. Although more subjects consented to this mode, only the first 105 ISO-compliant datasets were analyzed | Count of Participants | Participants |
|
| OG001 | Rectal Temperature Measurement | All enrolled pediatric subjects who had an ISO compliant data set collected for the rectal body site |
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Mean | Standard Deviation | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Mean | Standard Deviation | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Mean | Standard Deviation | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Mean | Standard Deviation | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Mean | Standard Deviation | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Clinical Bias | Clinical bias is the mean difference between the first device under test (DUT) output temperature (T1) and the corresponding reference clinical thermometer (TRCT) within the ISO-compliant analysis set and age group, calculated per ISO 80601-2-56:2017 + A1:2018 (refer to ISO formula [2]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Mean | Standard Deviation | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=5 Years - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Number | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <1 Year - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Number | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group <3 Months - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Number | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 3 Months to <1 Year - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Number | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 1 Year to <5 Years - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Number | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group 5 Years to <18 Years - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Number | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm for Age Group >=18 Years - Limits of Agreement | Limits of Agreement represent the magnitude of potential disagreement between outputs of two thermometers and are defined as 2 × the standard deviation (SD) of the temperature differences (T1 - TRCT) within the ISO-compliant analysis set and age group, as specified in ISO 80601-2-56:2017 + A1:2018 (refer to ISO formulas [3] and [4]). | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Number | degree Celsius | 20-30 minutes |
|
|
|
| Primary | Validate the Clinical Accuracy of the Timmy3 Thermometer Algorithm - Clinical Repeatability | Clinical repeatability is defined per ISO 80601-2-56:2017 + A1:2018 as the pooled within-subject standard deviation (SD) of triplicate device-under-test output temperatures for each anatomical site (refer to ISO formulas [5] and [6]). This outcome reports that SD as a single numeric value (°C); because it is a dispersion statistic (not a mean), no central-tendency measure applies. Higher SD indicates lower repeatability. | All enrolled subjects who had an ISO compliant data set collected. Age groups were classified as follows:
| Posted | Number | degree Celsius | 20-30 minutes |
|
|
|
| 0 |
| 371 |
| 0 |
| 371 |
| 0 |
| 371 |
The sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.