This is a fully decentralized retrospective, non-interventional study evaluating the diagnostic performance of the Withings Heart Function Risk Notification (HFRN), a software-only medical device (SaMD)
This is a fully decentralized retrospective study.
Study Type
OBSERVATIONAL
Enrollment
9,000
Software-only medical device (SaMD)
Ground-truth heart-failure case / control status derived from administrative claims by a deterministic, pre-specified rule set.
Withings (Sponsor) - Decentralized Retrospective Study, No Physical Sites
Issy-les-Moulineaux, Île-de-France Region, France
Sensitivity (Se) of the HFRN algorithm
Time frame: 13 weeks
Specificity (Sp) of the HFRN algorithm
Time frame: 13 weeks
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