Table 6 Comparative analysis with FDA-cleared devices
From: Fibricheck detection capabilities for atrial fibrillation (FDA–AF): a multicenter validation study
Device name | 510(k) number | Sensitivity (95% CI) | Specificity (95% CI) |
|---|---|---|---|
FibriCheck | K232804 | 96.3% (94.4–97.7%) | 99.3% (98.8–99.7%) |
FibriCheck | K173872 | 95.60% (no 95% CI reported) | 96.6% (no 95% CI reported) |
Coala heart monitor | K182040 | 97.2% (no 95% CI reported) | 94.6% (no 95% CI reported) |
Study watch with irregular pulse monitor | K192415 | 85% (79–90%) | 96% (93–99%) |
Halo AF detection system | K201208 | 93.3% (no 95% CI reported) | 99.1% (no 95% CI reported) |
Scan monitor | K201456 | 96.3% Lower bound 95% CI: 89.4%, No upper bound reported | 100% Lower bound 95% CI: 96.7% No upper bound reported |
Study watch with irregular pulse monitor (home) study watch with irregular pulse monitor | K213357 | 96.1% (92.7–98.0%) | 98.1% (97.2–99.1%) |
Withings scan monitor 2.0 | K230812 | 99% (93–100%) | 99% (97–100%) |
