EnsoSleep
EnsoData, Inc.EnsoSleep is a software medical device designed to analyze previously recorded physiological signals from sleep studies to automatically score sleep stages, detect arousals, leg movements, and various types of sleep-disordered breathing events. It supports both adult and pediatric patients and can be used for in-lab or home sleep tests. EnsoSleep assists clinicians by providing automated detection and scoring of events, which are then verified and can be edited by qualified clinicians to aid in diagnosing sleep disorders.
Intended Use
EnsoSleep is intended for use in the diagnostic evaluation by a physician to assess sleep quality and aid diagnosis of sleep disorders and respiratory related sleep disorders in pediatric (13 years and older) and adult patients via automatic analysis of physiological signals from polysomnography and home sleep tests.
Technology
EnsoSleep is software that processes recorded physiological signals such as EEG, ECG, EOG, EMG, airflow, oximetry, and others from polysomnography to automatically detect and score sleep stages, arousals, leg movements, and breathing events including obstructive apnea, central apnea, and hypopnea. It supports editing by clinicians and provides a cloud-based platform with a web dashboard for review and scoring. It includes automatic recognition of cardiac events but not intended for cardiovascular diagnosis.
Performance
Clinical validation included retrospective studies using thousands of sleep study epochs scored manually by experienced technologists to serve as a consensus reference. Performance metrics such as positive, negative, and overall agreement showed that EnsoSleep's automated scoring met or exceeded predicate device performance across multiple events including sleep staging, apnea-hypopnea events, arousal, leg movements, and respiratory rate events, in both adult and pediatric populations. Statistical analyses showed substantial equivalence, and performance was robust across the intended spectrum of disease severities.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/6/2021
5 months - 2
FDA Approval
6/16/2021
Other devices from EnsoData, Inc.
- EnsoSleep2017 • 510K
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