Safety And Performance - Withings SCANWATCH HWA09 Quick Installation Manual

Safety and Performance
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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 complexes, Scan Monitor reached a Fl-score of at least 99.19% on all the datasets, with the exception of
NSTDB where the Fl-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.
*/EC 60601-2-47:2012: Requirements for the Basic Safety and Essential Performance of Ambulatory
Electrocardiographic Systems.