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The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

Severity: Slight, Mild, Moderate, Severe, Profound
Configuration: High Frequency -Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other
Other: Low Tolerance to loudness

Sound F/XD Programmable Mini BTE Unitron Industries, Inc.

The provided document is a 510(k) clearance letter from the FDA for a hearing aid device, the Unitron Model Sound F/XD Programmable Mini BTE Hearing Aid (K974339).

This type of document primarily focuses on establishing "substantial equivalence" to a predicate device already on the market, rather than conducting a de novo study with acceptance criteria and detailed performance data like those for novel devices or AI/ML-based medical devices.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a specific study proving device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information.

The document indicates:

• Regulatory Class: I (21 CFR 874.3300/Procode: 77 ESD)
• Intended Use: To amplify sound for individuals with impaired hearing, for losses in slight, mild, moderate, and severe categories, with various configurations (high frequency-precipitously sloping, gradually sloping, reverse slope, flat).
• Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976.

The FDA letter explicitly states: "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions."

For this specific clearance, detailed clinical studies with the requested metrics were not required for this type of Class I device seeking substantial equivalence. The focus was on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

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