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) that analyzes longitudinal weight / BMI, body-water-percent variability, and activity (step) data collected passively by Withings connected smart scales and the Withings activity-tracking ecosystem. The study estimates Sensitivity (Se) and Specificity (Sp) of HFRN against a US claims-based (HealthVerity) heart-failure reference standard, evaluated on a pre-specified holdout test set. The findings support a 510(k) substantial-equivalence determination to the predicate Viz HCM (DEN230003) within the Cardiovascular machine learning-based notification software generic type (21 CFR 870.2380).
Age range
45 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Sensitivity (Se) and its 95% CI of the HFRN algorithm for heart-failure detection, evaluated on the pre-specified holdout test set.
Timeframe: 13 weeks
Specificity (Sp) and its 95% CI of the HFRN algorithm for heart-failure detection, evaluated on the pre-specified holdout test set.
Timeframe: 13 weeks