Arrhythmia, Healthy
Conditions
Keywords
medical device, validation, arrhythmia, ECG, pulse rate, Norbert Device, Norbert Health
Brief summary
The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
Detailed description
The study design is to validate the pulse and heart rate accuracy as required per ISO 80601-2-61, Clause 201.12.1.104. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of types of arrhythmias including tachycardia, bradycardia, atrial fibrillation, bigeminy, trigeminy, and others.
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
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects aged 18 or over * Ability to provide signed informed consent
Exclusion criteria
* Pregnant * Otherwise deemed unsuitable to participate in the study based on judgment of the study investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Average Error (MAE) | Up to 1 hour | MAE will be evaluated by Mean absolute error (MAE) of the pulse rate of the device compared to the heart rate measured from the RCECG. |
Countries
United States
Outcome results
None listed