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The Grind No More Version 2 and Grind No More Version 3 are indicated for use for protection against bruxism or nighttime teeth grinding. The devices are intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Grind No More 2 and Grind No More 3 are a posterior-only occlusive nightguards, consisting of two molar bite plates connected by a buccal retention band.

This submission is a Special 510(k) for a modified device. Special 510(k)s rely on a comparison to a predicate device and declarations of similarity rather than new clinical studies to demonstrate safety and effectiveness. Therefore, the information typically found in clinical studies (like acceptance criteria, sample sizes, ground truth establishment, etc.) is not present in this document.

Here's a breakdown based on the provided text:

No specific acceptance criteria or device performance data from a clinical study are reported in this document. The submission is focused on demonstrating substantial equivalence to predicate devices, not on validating performance against predetermined criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Grind No More 2 and Grind No More 3 are as safe and effective as the predicate devices. Grind No More 2 and Grind No More 3 have the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between Grind No More 2, Grind No More 3, and the predicate devices raise no new questions of safety or effectiveness." This statement is the primary form of "performance" assessment in this type of submission.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. No new test set or clinical study was conducted.
• Data Provenance: Not applicable. The submission relies on a comparison to previously cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No new test set requiring ground truth establishment was used.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No new test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a physical nightguard, not an AI-powered diagnostic tool. MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical nightguard.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. No new ground truth was established; the submission relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI or software algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable.

Summary of the Study (as described in the 510(k) submission):

The "study" in this context is a Special 510(k) submission designed to demonstrate substantial equivalence between the modified devices (Grind No More Version 2 and Version 3) and previously cleared predicate devices (Placontrol, Inc.'s Grind No More (K082301) and DenTek Oral Care, Inc.'s Comfort Fit NightGuard (K072147)).

The core argument is that:

• The intended uses are the same: "protection against bruxism or nighttime teeth grinding. The devices are intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding."
• Technological characteristics are similar: "posterior-only occlusive nightguards, consisting of two molar bite plates connected by a buccal retention band."
• Principles of operation are similar.
• "Minor technological differences" between the new and predicate devices "raise no new questions of safety or effectiveness."

Therefore, the "device meets the acceptance criteria" in the sense that the FDA has determined it is substantially equivalent to legally marketed predicate devices, implying it is as safe and effective. This determination is based on a comparative analysis of device characteristics, not on new clinical performance data.

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