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The Difiney Anti Snoring Device is intended to help reduce snoring in adults 18 years of age or older.

The Difiney Anti Snoring device is an intraoral device that is composed of an upper and lower intraoral trays with a handle that is used during the process of customizing the trays. The Difiney Anti Shoring device repositions the jaw anteriorly relative to the maxilla in order to increase the patient's pharyngeal space to improve the ability to exchange air and decrease air turbulence, a causative factor in snoring.

The provided text is a 510(k) summary for the Difiney Anti Snoring Device. It outlines the regulatory classification, intended use, and a comparison to a predicate device (SnoreRx). Crucially, the document states "Performance Testing - Clinical: Not Applicable" and "Performance Testing - Animal: Not Applicable."

This means the submission does not include data from a clinical study or animal study to demonstrate the device's performance based on specific acceptance criteria. Instead, the substantial equivalence determination is based on technological characteristics and non-clinical testing (biocompatibility and physical properties).

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, device performance from a study, sample sizes, expert involvement, or MRMC studies, because this information is explicitly stated as "Not Applicable" in the provided document.

The document's conclusion is that the device is substantially equivalent to the predicate based on technological characteristics and non-clinical testing, not on clinical performance metrics.

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