SOMNUM (SOMNUM)
Honeynaps Co., Ltd.SOMNUM is an AI-enabled software application designed to assist physicians in diagnosing sleep and respiratory-related sleep disorders by automatically analyzing polysomnography (PSG) data. It uses artificial intelligence algorithms to detect sleep stages, arousals, respiratory events like apnea, and periodic limb movements, allowing for efficient sleep study interpretation and report generation.
Intended Use
SOMNUM is an AI-enabled software program intended for use as an aid in the diagnosis of sleep and respiratory-related sleep disorders, providing automatic scoring and manual review of sleep stage classification, arousal detection, respiratory event detection, and leg movement detection via polysomnography data of adult patients.
Technology
SOMNUM is a stand-alone AI-enabled software that applies AI/ML-based algorithms to polysomnographic physiological data to automatically detect sleep stages (Wake, N1, N2, N3, REM), arousals, respiratory events (apnea, hypopnea) with subclassification (obstructive, central, mixed), and leg movement events. It allows physicians to review and modify the auto-scored results and generates detailed reports for clinical assessment.
Performance
Performance testing included software verification and validation following FDA and IEC 62304 standards, a large retrospective U.S. clinical validation study using 100 PSG recordings, and a Korean 48-case clinical validation study. SOMNUM showed high accuracy and sensitivity across sleep stages, arousals, respiratory events, and limb movements, exceeding performance targets and demonstrating statistically significant equivalence or superiority to predicate and reference devices.
Predicate Devices
No predicate devices specified
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