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The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching.

The Anti Grinding Guard is an over-the-counter (OTC), flexible and moldable one-piece dental mouth guard, which is used as a barrier between teeth for individual s who grind their teeth. The anti Grinding Guard is intended to be worn while sleeping. The guard is constructed of 100% thermoplastic ethylene-vinyl acetate copolymer. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. The mouth guard Is one model/size, is reusable by a single individual at least eighteen (18) years of age and is supplied as non-sterile.

The provided text is a 510(k) Pre-market Notification for a medical device called "Anti Grinding Guard." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new, independent set of clinical efficacy studies. Therefore, much of the requested information about acceptance criteria, detailed study designs, sample sizes, and expert adjudication for proving efficacy is not typically found in these documents.

However, I can extract information related to the non-clinical testing performed to support the substantial equivalence claim.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative table with specific target values and reported performance for each criterion in the way a clinical trial might. Instead, it states that "The non-clinical testing of Anti Grinding Guard demonstrates the device's performance in providing including hardness, water absorption and solubility testing, boiling/cooling water testing, impression test, separation test, and comparative wear test, which supports its substantial equivalence to the predicate device."

It implies that the "acceptance criteria" for these tests were met if the results demonstrated performance comparable to the predicate device and compliance with "pertinent standards and specifications."

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not provide specific sample sizes for the non-clinical tests. It doesn't specify the country of origin of the data or whether the tests were retrospective or prospective; these details are typically not included in a 510(k) summary for non-clinical testing unless directly relevant to a specific regulatory standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to the non-clinical bench testing described. "Ground truth" and "experts" are concepts usually associated with clinical studies or performance evaluation where human interpretation of data is involved (e.g., image analysis, diagnosis). The non-clinical tests focus on material properties and physical performance.

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

This is not applicable to the non-clinical bench testing. Adjudication methods are typically used in clinical studies where multiple human evaluators assess outcomes that may be subjective.

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:

This is not applicable. The device is a physical "Anti Grinding Guard," not an AI diagnostic or assistance tool that would involve human readers.

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

This is not applicable, as the device is a physical product, not an algorithm.

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

For the non-clinical tests, the "ground truth" would be established by objective measurements and standardized testing procedures to determine material properties and performance characteristics according to relevant international standards (e.g., ISO 10993 for biocompatibility) and engineering principles. The document states that the testing demonstrated compliance with "pertinent standards and specifications" and met "the requirements of the study protocols."

8. The sample size for the training set:

This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.

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

This is not applicable for the same reason as point 8.

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