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• Protection against bruxism or nighttime teeth grinding.
• Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding.

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I am sorry, but the provided text only contains an FDA clearance letter for a device called "ClenchGuard" and its indications for use. It primarily focuses on regulatory approval and does not include information about acceptance criteria, a study proving device performance, or any of the detailed technical and clinical study parameters you've requested (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

Therefore, I cannot fulfill your request for that specific information based on the text provided.

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