RX-1 Sleep is a Software as a Medical Device (SaMD) that measures the apnea–hypopnea index (AHI), sleep/wake, posture and respiratory effort. RX-1 Sleep is indicated for patients suspected of having sleep apnea. RX-1 Sleep employs two cloud-based static/locked AI deep learning models for AHI and for sleep/wake that receive inputs from two FDA-cleared devices used in the clinical and home environment: a) the Rhythm Express RX-1 mini Remote Cardiac Monitoring System (RCMS) (K241179), and b) a Viatom pulse oximeter (K191088). Additionally, RX-1 Sleep includes two non-AI device software functions (DSFs) that rely on inputs from the RX-1 mini and use traditional signal processing techniques for respiratory effort estimation and posture detection during sleep. These non-AI-DSFs do not interact with the AI-DSFs. The RX-1 mini is worn on the chest and communicates ECG and heart rhythm information, as well as actigraphy from an on-board triaxial accelerometer to the RS-1 cloud-based server via a cellular or Wi-Fi connection. The pulse oximeter is worn as indicated and records functional oxygen saturation of arterial hemoglobin (SpO2) while the patient is asleep. Pulse oximetry data are communicated to the RX-1 mini via a secure Bluetooth link for upload of SpO2 data to the RS-1 server and all data are synchronized. RX-1 Sleep resides on the RS-1 Server and outputs a consolidated sleep report, accessible via the RX-1 mini Clinic Portal. The Operator Portal presents RX-1 Sleep outputs and full disclosure signals for review by a qualified healthcare professional.
An interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].
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