(141 days)
The AURIS I and AURIS II ABR Systems provide information regarding the functional integrity of the peripheral and central auditory system. It tests for auditory evoked potentials as an aid in detecting hearing loss and lesions in auditory pathways. It is ittended for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.
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The provided text does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Auris AEP" (later referred to as "AURIS I and AURIS II ABR Systems"). It establishes substantial equivalence to a predicate device and outlines regulatory guidelines.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).