EnsoSleep
EnsoData, Inc.EnsoSleep is a software tool that uses AI algorithms to analyze sleep study data, including brain waves and breathing patterns, to help physicians evaluate sleep quality and diagnose sleep-related disorders such as sleep apnea. It automates scoring of sleep stages, detection of arousals, leg movements, and breathing events, improving efficiency while requiring clinician verification.
Intended Use
EnsoSleep is intended for use for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory related sleep disorders in adults only. It analyzes physiological signals and automatically scores sleep study results including staging of sleep, detection of arousals, leg movements, and sleep disordered breathing events including obstructive apneas.
Technology
EnsoSleep is a software application that analyzes previously recorded physiological signals from polysomnographic studies, including EEG signals in EDF/EDF+ file formats. It uses AI algorithms to automate recognition of sleep stages, respiratory events (apneas and hypopneas), arousals, and leg movements. Processing is cloud-based on Windows platforms with enhancements in efficiency, reliability, cyber security, and throughput from predicate devices.
Performance
Performance testing included verification, validation, and clinical testing on 72 retrospective subject polysomnography datasets. EnsoSleep was compared with predicate devices for sleep staging, sleep apnea diagnosis, and event detection (sleep disordered breathing, apnea types, arousals, and leg movements). Statistical analysis showed EnsoSleep achieved equivalent or better agreement metrics, demonstrating substantial equivalence in safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/20/2016
6 months - 2
FDA Approval
3/31/2017
Other devices from EnsoData, Inc.
- EnsoSleep2021 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.