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1. As an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing;

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

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I apologize, but the provided text only contains an FDA 510(k) clearance letter for the NTI ClenchGuard device. It does not include information about acceptance criteria, study details, device performance data, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA reviewed how the NTI ClenchGuard compares to existing devices for the same intended use. The letter does not detail any novel studies conducted to prove the device meets specific acceptance criteria in the way you've described for an AI/algorithm-based device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the information provided.

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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.

Not Found

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.

Ask a specific question about this device