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Oxford BioSignals BioSomnia V3 is a three channel ambulatory device providing signal amplification of two channels of EEG and one of EMG and connections to external devices for subsequent EEG / EMG signal display, storage and analysis. The device is designed to be used overnight in the patient's home environment to assist the physician in diagnosing sleep disorders.

Oxford BioSignals BioSomnia V3 is a three channel ambulatory device providing signal amplification of two channels of EEG and one of EMG and connections to external devices for subsequent EEG / EMG signal display, storage and analysis.

This document is a 510(k) clearance letter for the BioSomnia V3 device. It states the device's indications for use but does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on specific performance data or a clinical study demonstrating predefined acceptance criteria.

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The Oxford BioSignals BioSomnia is a single channel ambulatory EEG with a software package designed for use as an adjunct for the physician in their diagnosis of sleep disorders and to quantify sleep and wakefulness on a second by second basis.

The device is designed to be used overnight in the patient's home environment to assist the physician in diagnosing sleep disorders.

a single channel ambulatory EEG with a software package

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them.

The document is an FDA 510(k) clearance letter for the "Biosomnia" device, indicating its substantial equivalence to a predicate device. While it states the "Indications for Use" (which are relevant to what the device is intended to do, and thus implicitly what needs to be evaluated), it does not include:

• A table of acceptance criteria and reported device performance.
• Details about any specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information about multi-reader multi-case (MRMC) studies or standalone performance.
• Training set details (sample size, ground truth establishment).

The letter focuses on regulatory clearance based on substantial equivalence, rather than detailing the results of performance studies that would be submitted to support such clearance.

Ask a specific question about this device