Dreem 3S
Beacon Biosignals, Inc.The Dreem 3S is a wearable headband device that records brain electrical activity (EEG) and movement data during sleep. It uses AI algorithms based on neural networks to automatically analyze this data and produce detailed sleep stage reports for adults. This helps clinicians assess sleep patterns and disturbances remotely in home or healthcare environments.
Intended Use
The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep in the home or healthcare environment. It can output a hypnogram of sleep scoring by 30-second epoch and summary of sleep metrics derived from this hypnogram. Used for assessment of sleep on adults 22 to 65 years old.
Technology
The Dreem 3S is a flexible headband device containing 6 EEG electrodes and a 3D accelerometer for head movement. It includes a bone conduction speaker and an LED power indicator. Raw EEG and accelerometer data are sent to servers for analysis. The sleep staging algorithm is an artificial neural network that processes EEG and accelerometer data, including recurrent and attention layers, providing automatic 30-second epoch staging. The device generates reports in PDF and raw data files in EDF format.
Performance
No new clinical, bench, or animal testing performed. Performance characteristics rely on previous version (predicate K223539). The device includes a Predetermined Change Control Plan (PCCP) allowing planned updates to signal preprocessing, machine learning model, and probability post-processing algorithms to improve sleep staging, with validation and verification conducted on each modification to ensure clinical performance is non-inferior.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/17/2024
4 months - 2
FDA Approval
11/22/2024
Other devices from Beacon Biosignals, Inc.
- SleepStageML2024 • 510K
- Dreem 3S2023 • 510K
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