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OTC: Protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. Protection against teeth grinding, bruxism and jaw clenching. Rx: Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

The Freeway Comfort" Bite Guard dental guard is composed of a moldable thermoplastic inner lining that adapts to the teeth, and a hard outer shell. The shell is composed of a hard polycarbonate material. When heated, the moldable thermoplastic material is molded to fit the user's upper anterior teeth. The hard outer shell contacts the lower anterior teeth and prevents contact of the user's posterior teeth.

The provided document is a 510(k) summary for a dental device, the "Freeway Comfort™ Bite Guard." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria.

Therefore, the document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria.

Instead, the document focuses on:

• Device Description: What the device is made of and how it works.
• Intended Use/Indications for Use: The medical conditions the device is designed to address.
• Predicate Devices: Identifying similar devices already on the market.
• Substantial Equivalence Argument: Explaining why the new device is as safe and effective as the predicate devices, despite minor technological differences.

Based on the provided text, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance: This type of data is not included in this substantial equivalence document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or associated data is described.
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): No ground truth establishment for a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is mentioned as there is no test set.
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 an AI device, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not an AI device, and no such performance evaluation is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is mentioned in the context of device performance testing.
8. The sample size for the training set: There is no mention of a training set as this is not an AI/software device undergoing performance training.
9. How the ground truth for the training set was established: Not applicable, as there is no training set described.

In summary, the provided document is a regulatory submission for substantial equivalence, not a scientific study detailing performance data against predefined acceptance criteria.

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