VitalRhythm

VitalRhythm is a cloud-based software application that continuously analyzes cardiac arrhythmias from single-lead ECG data and RR-interval information transmitted from the VitalPatch biosensor. It is intended for outpatient cardiac telemetry and non-urgent patient monitoring in non-critical healthcare settings, displaying detected arrhythmias to qualified healthcare professionals and cardiac technicians for review and confirmation. The device is not intended for life-supporting systems, critical care, or as the sole means of diagnosis.

VitalRhythm uses a proprietary deep-learning algorithm to analyze single-lead ECG data (125 Hz sampling, -10 to +10 mV range) from the VitalPatch via a secure cloud API. Unlike the two-lead DeepRhythmAI predicate, VitalRhythm analyzes single-lead ECG similar to HeartKey Rhythm. It detects arrhythmias but does not perform beat detection itself; beat features like QRS detection and heart rate are provided by the compatible VitalPatch reference device. All three devices operate as standalone software using machine-learning algorithms without primary GUI.

Not stated in this summary. The document describes nonclinical performance testing using retrospective ECG data but does not cite specific ISO, IEC, or ASTM standards.

VitalRhythm demonstrates substantial equivalence because it performs the same fundamental function as the predicate DeepRhythmAI—continuous automated analysis of ECG data for arrhythmia detection in non-critical outpatient settings using proprietary algorithms. Nonclinical testing on 3,309 patients across 7 US sites showed sensitivity, specificity, PPV, NPV, and accuracy ≥95% for non-sinus arrhythmias and ≥90% for sinus rhythms, meeting predefined acceptance criteria. The technological differences (single- vs. two-lead analysis, VitalConnect-only compatibility, lack of beat detection) do not raise new safety or effectiveness concerns because beat detection is supplied by compatible cleared reference devices and the single-lead analysis is comparable to HeartKey Rhythm. Subgroup analyses showed no statistically significant performance heterogeneity across demographics or testing sites, establishing that VitalRhythm performs as well as or better than predicates for its intended use.