(87 days)
The device is used to perform pure tone threshold tests.
Not Found
This document is a 510(k) clearance letter from the FDA for the K-15 Audiometer. It indicates that the device has been found substantially equivalent to a predicate device for performing pure tone threshold tests.
The document does not contain the following information:
- A table of acceptance criteria and reported device performance.
- Details about a study proving the device meets acceptance criteria.
- Sample size used for a test set or its data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- References to a multi-reader, multi-case (MRMC) comparative effectiveness study, nor effect sizes for human readers with and without AI assistance.
- Information about a standalone algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for a training set.
- How ground truth for a training set was established.
Therefore, I cannot provide the requested information from the given text. The provided text is a regulatory clearance document, not a performance study report.
§ 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.