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The Clench Relief Mouth Piece PRO RX is indicated for protection of teeth and restorations from injury due to teeth grinding, bruxism, and jaw clenching; temporary relief of TMD and bruxism by reducing muscle tension, and temporary treatment of TMD along with the relief of associated headaches and pains.

The Clench Relief Mouth Piece PRO RX is a custom-fit temporary mouthguard which allows the user to achieve a jaw position that alleviates clenching, grinding, and bruxism and help diminish TMD type muscle pain symptoms along with jaw clicking and popping. It allows the prescriber to set and create a new bite plane for the patient that allows the lower jaw to come down and forward from its habitual bite position thus freeing it from its habitual muscle tension. The mouthguard kits contain the Clench Relief Mouthpiece Frame with alignment guide and Clench Relief Fit Material (VPS putty provided as catalyst and base). The mouthpiece frame is packed with mixed putty and placed passively over the lower teeth. The end user must bite on the alignment guide for 2 minutes while the Clench Relief Fit Material sets. Heating of the mouthguard/putty is not required for molding. The mouthpiece frame and alignment guide are manufactured from ethylvinyl acetate (EVA). The putty is manufactured from vinyl polysiloxane (VPS) which was previously cleared under K821221.

This FDA 510(k) Premarket Notification document pertains to the Clench Relief Mouth Piece PRO RX, a custom-fit temporary mouthguard. The document focuses on demonstrating that this device is substantially equivalent to legally marketed predicate devices. It does not contain information about a study that establishes acceptance criteria and then proves the device meets those criteria for the purposes of evaluating its clinical performance or efficacy.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

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

This information is not provided in the document. The document lists performance data categories such as "Biocompatibility," "Material hardness per ANSI/ADA 99," "Tear strength per ANSI/ADA 99," and "Water sorption per ANSI/ADA 99." However, it does not provide specific acceptance criteria for these tests nor does it report the device's actual performance results against any such criteria. It only states that these studies "were performed...in support of the substantial equivalence determination."

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

This information is not provided as there are no clinical studies or test sets evaluating device performance in the context of efficacy or clinical outcomes mentioned. The "performance data" refers to material property tests rather than clinical trials.

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 as there is no clinical test set requiring expert-established ground truth.

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

This information is not applicable as there is no clinical test set requiring adjudication.

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 information is not applicable. The device is a physical mouthguard, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable. The device is a physical mouthguard, not an algorithm.

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

This information is not applicable as there are no clinical efficacy studies described that would require ground truth. The "performance data" mentioned relates to material characteristics, which are evaluated against established standards (e.g., ISO, ANSI/ADA) rather than a "ground truth" in a clinical sense.

8. The sample size for the training set

This information is not applicable as there is no mention of a training set. The device is a physical product, not a machine learning model.

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

This information is not applicable as there is no mention of a training set or associated ground truth.

In summary:

The provided FDA 510(k) document is for a medical device (a mouthguard) seeking clearance based on substantial equivalence to existing devices. The document highlights material property testing to ensure safety and compatibility, but it does not include any clinical study data or performance metrics that would typically address a device's clinical efficacy, diagnostic accuracy, or comparative effectiveness in the way an AI-powered device or a drug might. Therefore, most of the specific questions regarding acceptance criteria and study details for such evaluations cannot be answered from this document.

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