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Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices.
The main objectives of this study are:
This Study carried out in accordance with the ISO 80601-2-56: 2017, which included definitions for the age groups and sample sizes, the definition of fever, the flowchart for relevant procedures, and statistical methods for clinical performance.
All subjects were measured by the reference device (electronic thermometer MT-B231) and three investigational devices under test evaluation (infrared forehead thermometer GE-TF03, infrared ear thermometer GE-TE06, and electronic thermometer MT-B321FB). For each subject, the reference device measured one time and each investigational device measured three times respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects: 0 up to 1 year | Other | Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer |
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| Subjects: Older than 1 year and younger than 5 years | Other | Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer |
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| Subjects: Older than 5 years | Other | Collecting temperatures using the "Geon" Digital, Infrared Ear and Infrared Forehead thermometer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infrared Forehead Thermometer (GE-TF03) | Device | Infrared Forehead Thermometer (GE-TF03) is an investigational device intended to measure body temperature on the forehead. GE-TF03 took three measurements for each subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Bias | Mean Difference between investigational thermometer and reference thermometer. | Through study completion, an average of 2 years |
| Limits of Agreement | The magnitude of a potential disagreement between investigational thermometer and reference thermometer. | Through study completion, an average of 2 years |
| Clinical Repeatability | Pooled standard deviation of triplicate measurements over the entire population of subject | Through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei-Te Lei | Hsinchu MacKay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hsinchu MacKay Memorial Hospital | Hsinchu | Taiwan | ||||
| HsinChu Municipal MacKay Memorial Hospital |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Infrared Ear Thermometer (GE-TE06) | Device | Infrared Ear Thermometer (GE-TE06) is an investigational device intended to measure body temperature in the ear canal. GE-TF06 took three measurements for each subject. |
|
| Electronic Thermometer (MT-B321FB) | Device | Electronic Thermometer (MT-B321FB) is an investigational device intended to measure body temperature on the temporal artery. MT-B321FB took three measurements for each subject. |
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| Electronic Thermometer (MT-B231) | Device | Electronic Thermometer (MT-B231) is a reference device that measured axillary temperature one time for each subject. |
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| Hsinchu |
| Taiwan |