NEAT 001 is a software medical device that automatically analyzes EEG data obtained during sleep studies to detect different stages of sleep according to established sleep medicine guidelines. It helps clinicians by providing automated scoring and visualization of sleep stages, improving the efficiency and consistency of sleep evaluations in adult patients.
Intended Use
Automatic scoring of sleep EEG data to identify stages of sleep according the American Academy of Sleep Medicine definitions, rules and guidelines. It is to be used with adult populations.
Technology
NEAT is a client-server software system that includes a user interface running in a web browser, a RESTful API backend, and a containerized command line software module (neat-cli) running on a server that uses machine learning algorithms to analyze EEG data files and score sleep stages, producing visualizations and summary reports.
Performance
Performance testing compared NEAT with the predicate device EnsoSleep using clinical polysomnographic data, assessing sensitivity, specificity, and overall agreement for sleep stage classification. Results showed NEAT is substantially equivalent to EnsoSleep and within the range of variability expected among expert human raters, with some differences in classification accuracy by sleep stage.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/10/2025
3 months - 2
FDA Approval
4/10/2025
Other devices from Brain Electrophysiology Laboratory Company, LLC
- Sourcerer2024 • 510K
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