CASSIE
Wesper, Inc.Cassie is a software tool that automatically analyzes physiological data collected during sleep to help healthcare professionals evaluate and manage sleep disorders. It processes signals like photoplethysmogram (PPG) and oxygen saturation to provide detailed sleep staging and respiratory event information, assisting in diagnosing conditions like sleep apnea.
Intended Use
Cassie is a Software as a Medical Device (SaMD) that automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data, typically collected during sleep using compatible devices, intended to aid healthcare professionals in the evaluation of sleep disorders and management of sleep disordered breathing for adults.
Technology
Cassie is a cloud-based AI system that processes physiological data from PPG and optionally SpO2 collected during sleep to generate clinical metrics such as sleep architecture classification, respiratory events, and summary information including apnea-hypopnea index (wAHI). It uses machine learning on cardiopulmonary physiological markers and produces outputs as JSON files accessible via API.
Performance
Cassie underwent software verification, validation and cybersecurity testing according to IEC 62304 and FDA guidance, concluding safe performance. Clinical validation against polysomnography (PSG) on 474 subjects showed high correlation for apnea-hypopnea index (0.96) and total sleep time (0.86), with sensitivity around 97% and specificity near 87% for OSA detection, demonstrating performance comparable to predicate devices.
Predicate Devices
No predicate devices specified
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