Happy Health Home Sleep Test
Happy Health Inc.The Happy Health Home Sleep Test is a software device that processes data collected from wearable sensors, such as a smart ring, to help healthcare providers evaluate adults suspected of sleep apnea. It records, analyzes, and presents biophysical signals like movement and blood flow to produce sleep parameters including apnea-hypopnea index and total sleep time, aiding clinicians in the diagnosis of sleep-related breathing disorders.
Intended Use
The Happy Health Home Sleep Test is a Software as a Medical Device that uses data from wearable devices to record, analyze, display, export, and store biophysical parameters to aid in evaluating sleep‐related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use on individuals who are 22 years of age or older in clinical and home settings under the direction of a trained healthcare provider.
Technology
The device is a SaMD that processes data from an external hardware device (smart ring) equipped with sensors for photoplethysmography and accelerometry. It collects input signals (acceleration/movement and PPG), uses algorithms to compute outputs like Apnea Hypopnea Index and Total Sleep Time, producing reports accessible to clinicians via a web-based viewer.
Performance
Performance testing included software verification and validation per IEC 62304 and FDA guidance, cybersecurity, and usability testing. Clinical testing with 90 subjects demonstrated that the device's Apnea Hypopnea Index output correlates strongly with manual scoring per AASM standards, and total sleep time measurements have comparable accuracy to manual polysomnography scoring.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/29/2024
10 months - 2
FDA Approval
6/18/2025
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