Safety And Performance - Withings ScanWatch 2 Product Manual

Security
Withings recommends that you add a passcode (personal identification number [PIN]), Face ID or Touch ID (finger-
print) to your phone to add a layer of security. It is important to secure your phone since you will be storing personal
health information. Users will also receive additional update notifications on the device via the app, and updates are
delivered wirelessly, encouraging rapid adoption of the latest security fixes.

Safety and Performance

Scan Monitor software's ability to accurately classify an ECG recording into Atrial Fibrillation and normal sinus
rhythm categories was tested according to the IEC 60601-2-47* standard and a clinical study with 262 subjects. On
five public databases, the Scan Monitor demonstrated 99.06% sensitivity in classifying Atrial Fibrillation and 98.66%
specificity in classifying normal sinus rhythm in classifiable recordings. In the beat-to-beat detection of QRS com-
plexes, Scan Monitor reached a F1-score of at least 99.19% on all the datasets, with the exception of NSTDB where
the F1-score was 90.65% because of digitally added noise. Rhythm classification by Scan Monitor was compared to
ECG recordings reviewed by cardiologists in a clinical validation study with 262 patients. 19.5% of recordings were
inconclusive. On conclusive recordings, the sensitivity in classifying Atrial Fibrillation was 96.3% (lower bound of the
95% confidence interval: 89.4%) and the specificity in detecting normal sinus rhythm was 100.0% (lower bound of
the 95% confidence interval: 96.7%). These results reflect use in a controlled environment. Real-world use of Scan
Monitor may result in a greater number of strips being deemed inconclusive.
*IEC 60601-2-47:2012: Requirements for the Basic Safety and Essential Performance of Ambulatory Electrocardio-
graphic Systems. Regarding safety, the ScanWatch 2 has been tested and deemed in compliance according to IEC
60601-1 and its applicable collateral standards (IEC 60601-1-2:2014, IEC 60601-1-11:2015). This device is in compliance
with ISO 10993-1:2009.