(90 days)
Capella is designed to test cochlear function of both infants and adults in a hospital, nursery, ENT clinic or audiology office. It allows the operator to get information about a person's hearing without through or requiring any response from the individual being tested.
Capella Cochlear Emissions Analyzer
The provided text is a 510(k) premarket notification letter from the FDA to Madsen Electronics, Inc. regarding their Capella Cochlear Emissions Analyzer. It states that the device is substantially equivalent to legally marketed predicate devices.
The information needed to describe acceptance criteria and the study that proves the device meets those criteria is not present in the provided document. This document is an FDA clearance letter, which confirms substantial equivalence but does not detail the specific performance studies, acceptance criteria, or their results.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth establishment.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.