RX-1 Sleep
Vivaquant, Inc. Dba Rhythm ExpressRX-1 Sleep is an AI-powered cloud-based software that assists healthcare professionals in evaluating sleep apnea by analyzing data from wearable sensors measuring heart rhythm, oxygen saturation, and motion during sleep. It provides clinicians with detailed reports about apnea severity, sleep patterns, posture, and respiratory effort to aid diagnosis and treatment.
Intended Use
RX-1 Sleep is a Software as a Medical Device (SaMD) to aid in the evaluation of sleep-related breathing disorders in adults suspected of having sleep apnea. It analyzes inputs from two FDA-cleared devices: the Rhythm Express RX-1 mini and a Viatom pulse oximeter, and provides biophysical parameters recorded and stored for presentation to a Healthcare Professional under their direction.
Technology
RX-1 Sleep uses two cloud-based static/locked deep learning AI models for apnea-hypopnea index (AHI) and sleep/wake classification based on inputs from the Rhythm Express RX-1 mini chest-worn ECG sensor and a finger-worn Viatom pulse oximeter. It also includes traditional signal processing of accelerometer data for respiratory effort and posture detection. Data are communicated securely via cellular/Wi-Fi and Bluetooth to a cloud server where analysis is performed and reports generated.
Performance
Clinical validation was performed against gold-standard polysomnography (PSG) involving 476 subjects in the VIVA-STAGES study. Performance metrics demonstrate high sensitivity and specificity for diagnosing mild to severe sleep apnea (AHI≥5, ≥15, ≥30), and good agreement with PSG measurements using Bland-Altman analysis. The device showed sensitivity around 87-91% and specificity in the range of 83-97% across various thresholds. Additional performance measures confirmed accurate detection of sleep/wake states, posture, and respiratory effort.
Predicate Devices
No predicate devices specified
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