Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Internal decision made by Norbert Health
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Northwell Health | OTHER |
Not provided
Not provided
Not provided
The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).
The study design is based on the ISO 80601-2-56, Clause 201.102 for adjusted mode clinical thermometers. The study is designed to be a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's temperature measurement compared to a standard FDA 510(k)-cleared reference clinical thermometer (RCT).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norbert Device | Device | The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Bias | Clinical Bias will be evaluated by comparing the first recorded measurement using ND with the corresponding measurement recorded by the RCT. The bias is calculated per IEC 80601-2-56, Clause 201.103.3. | Up to 1 hour |
| Limits of Agreement | Limits of Agreement (LOA) will be calculated using all three measurements by the ND and the corresponding measurements by the RCT. The LOA is calculated per IEC 80601-2-56, Clause 201.103.4. | Up to 1 hour |
| Clinical Repeatability | Clinical Repeatability is calculated by a pooled standard deviation of the triplicate measurements over the entire population of subjects. The method to calculate Clinical Repeatability is per IEC 80601-2-56, Clause 201.102.5. | Up to 1 hour |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study will be conducted within an Emergency Department where each subject is assigned an Emergency Severity Index (ESI) score. Only subjects with ESI scores ranging from 3-5 will be recruited for the study to prevent intervening with standard patient care.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided