(126 days)
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.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).