(51 days)
The Artisan™ is intended to be used by Physicians or trained technicians for acquisition of EEG and polygrasomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations commonly used in clinics. It does not involve any patient monitoring or diagnosis.
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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a device named "Artisan™ Acquisition System for EEG and Polysomnography." It confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance requirements.
However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test or training sets, data provenance, expert qualifications, or adjudication methods for ground truth.
- Information about MRMC studies, standalone algorithm performance, or the type of ground truth used.
Therefore, I cannot fulfill your request based on the provided text.
§ 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).