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Protect-It Custom Fit Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.

Protect-It Custom Fit Dental Guard is an over-the-counter device to be used by lay people for protection against the effects of nighttime teeth grinding. It is made of a single thermoplastic resin, ethylene vinyl acetate copolymer, EVA, which is easily molded to the teeth when heated. It is a full-occlusal guard worn on the upper teeth, providing a cushion to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth associated with bruxism.

The provided text is a 510(k) premarket notification for a medical device: DOC Brands, Inc.'s Protect-It Custom Fit Dental Guard. This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study as would typically be done for a new or high-risk device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a test set, expert adjudication, MRMC studies, standalone performance, or training set details for an AI/ML device.

The relevant sections of the document describe:

• Substantial Equivalence Discussion: This is the core of the submission, comparing the subject device to a predicate (DenTek Oral Care, Inc.'s Ready-Fit Disposable Dental Guard - K151149) and a reference device (DenTek Oral Care, Inc.'s Custom Comfort Nightguard Version 2 - K091660) across various characteristics like manufacturer, 510(k) #, device classification, regulation #, product code, regulatory class, description, packaging, design, indications for use, OTC/Rx status, user population, technological characteristics, duration of use, materials, physical properties (tensile strength, elongation, hardness, melt index, density), fit, dimensions, weight, sterilization, and cleaning method.
• Non-Clinical Performance Testing: This section details "bench testing" and "biocompatibility testing."
  • Bench Testing: An "in-home use test (IHUT)" was conducted to validate the design and performance expectations, specifically verifying reusability. The document references "Section 18: Bench Testing, Attachment 4A: Bench Test Protocol, 4B: Bench Test Engineering Study, and Attachment 4C: Bench Test Data" which are not provided in the given text.
  • Biocompatibility Testing: Four tests were performed according to ISO standards: In-vitro Cytotoxicity (ISO 10993-5:2009(E)), Skin Sensitization (ISO 10993-10:2021(E)), Intracutaneous Reactivity (ISO 10993-23:2021(E)), and Oral Mucosa Irritation (ISO 10993-23:2021(E)). The results indicated the device was non-cytotoxic, non-sensitizer, non-reactive, and non-irritant, respectively.

In summary, the provided document is a regulatory submission for substantial equivalence of a physical dental guard, not a study proving an AI/ML device meets acceptance criteria through a rigorous test set and expert review. Therefore, I cannot extract the specific information requested in your prompt.

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