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The device is used to perform pure tone threshold tests.

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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.

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