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The Refuge Tinnitus Maskers styles are In-The Canal and Behind-The-Ear that are electronic; air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Refuge Tinnitus Masker is intended for those individuals who experience tinnitus, and do not need or desire amplification. The intended use of this device includes it's fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis and treatment of tinnitus

electronic; air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Refuge Tinnitus Maskers styles are In-The Canal and Behind-The-Ear.

The provided document is a 510(k) clearance letter from the FDA for a device called "Refuge Tinnitus Masker." This letter primarily communicates the FDA's "substantial equivalence" determination to a legally marketed predicate device, indicating that the new device does not raise new questions of safety or effectiveness.

It does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding development, training sets, or expert ground truths. These types of details are typically found in the 510(k) summary or other sections of the submission, not in the clearance letter itself.

Therefore,Based on the provided document (a FDA 510(k) clearance letter), I am unable to provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter states that the device, "Refuge Tinnitus Masker," has been determined to be "substantially equivalent" to a legally marketed predicate device. This determination is based on the comparison to existing devices and does not typically include a detailed report of novel clinical studies with specific acceptance criteria beyond demonstrating equivalence.

The document only provides:

• Trade/Device Name: Refuge Tinnitus Masker Sound Generator
• Regulation Number: 21 CFR 874.3400
• Regulation Name: Tinnitus masker
• Regulatory Class: Class II
• Product Code: KLW
• Indications For Use: The Refuge Tinnitus Maskers styles are In-The Canal and Behind-The-Ear that are electronic; air-conduction broadband noise generator intended to generate noise of sufficient intensity and bandwidth to be used for tinnitus masking therapy. The Refuge Tinnitus Masker is intended for those individuals who experience tinnitus, and do not need or desire amplification. The intended use of this device includes its fitting by a qualified audiologist or other hearing healthcare professional familiar with the diagnosis and treatment of tinnitus. The target population is the adult population over 18 years of age.

To answer your specific questions, additional documentation from the original 510(k) submission, such as the 510(k) summary, clinical study reports, or performance data, would be required. This letter merely confirms regulatory clearance based on substantial equivalence.

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