Febrile Illness, Healthy
Conditions
Keywords
medical device, validation, febrile, thermometer, body temperature, Norbert Device, Norbert Health
Brief summary
The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).
Detailed description
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).
Interventions
DEVICENorbert Device
The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate.
Sponsors
Northwell Health
Norbert Health
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects over 22 years of age * Ability to provide signed informed consent, and/or have a legally authorized representative (LAR) willing to provide informed consent on behalf of the subject * ESI score of 3-5
Exclusion criteria
* Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the study procedure * Recent immunization within seven days of the study procedure * Pregnancy * ESI score of 1-2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Bias | Up to 1 hour | 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. |
| Limits of Agreement | Up to 1 hour | 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. |
| Clinical Repeatability | Up to 1 hour | 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. |
Outcome results
None listed