On July 16, HoneyNaps announced that Somnum v3.0, its artificial intelligence-based software for polysomnography analysis, received U.S. Food and Drug Administration 510(k) clearance under clearance number K253390. The FDA clearance expands the software’s capabilities for automated analysis of sleep-disordered breathing.
About Somnum v3.0
Somnum is an AI-enabled stand-alone software application that analyzes previously recorded physiological data from adult level 1 sleep studies. The software automatically detects events and displays scoring results using AI-based algorithms across its functional modules. According to the FDA 510(k) summary, physicians can review, edit, or delete auto-scored events and generate a sleep summary report that includes tables and graphs for clinical assessment of sleep disorders.
The cleared version includes AI/ML-based algorithms for sleep stage classification, arousal detection, respiratory event detection, and leg movement detection. It automatically detects apnea and hypopnea events and classifies apnea as obstructive, central, or mixed. According to HoneyNaps, Somnum v3.0 is “designed to distinguish different apnea subtypes that may be challenging to differentiate through manual scoring alone.”
| Category | SOMNUM 3.0 | Clinical Value | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Analysis Capability | Automated detection and individual analysis of Hypopnea, Obstructive Apnea, Central Apnea, and Mixed Apnea |
Supports detailed respiratory event analysis |
||||||||
| Performance Evaluation |
AI performance validated at the individual event level |
Improved analytical precision and broader AI capabilities |
||||||||
| AI Features | Automatic detection and classification of respiratory event subtypes |
Advanced AI algorithms |
||||||||
| Overall Percent Agreement (OPA) |
|
High agreement across respiratory event categories |
Figure 1: Key Enhancements in SOMNUM V3.0; source
The device is intended for use as an aid in the diagnosis of sleep and respiratory-related sleep disorders. It is intended for analysis, manual scoring or rescoring, display, retrieval, summarization, and report generation of digital data collected by monitoring devices typically used to evaluate sleep and respiratory-related sleep disorders. The device is to be used under the supervision of a physician in adults age 22 and older.
Read more industry news from the AASM.
