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The CustMBite Dental Guard is an over-the-counter dental guard indicated for the protection against bruxism – the nighttime clenching and grinding of the teeth.

It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated with teeth grinding.

The CustMBite Dental Guard is intended for individuals age 18 and older.

CustMbite Dental Guard is an over-the-counter dental protector, which is used as a barrier between teeth for individuals who grind their teeth. The CustMbite Dental Guard is intended to be worn while sleeping (e.g., at night or while napping). Through the process of customization using a boil and bite technique, the device fits an individual mouth adapting to a given person's oral tissue contours.

It appears there might be a misunderstanding of the provided document. The document is an FDA 510(k) clearance letter for a dental guard (CustMBite Dental Guard) and its associated 510(k) summary. It describes the device, its intended use, and demonstrates substantial equivalence to a predicate device, as required for 510(k) clearance.

This document does not describe an AI/ML-driven medical device, nor does it contain information about acceptance criteria for an AI model's performance, a study proving an AI device meets acceptance criteria, expert adjudication, or MRMC studies.

Instead, it details:

• Device: CustMBite Dental Guard, an over-the-counter dental guard for bruxism.
• Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
• Key Information for a Traditional Device:
  • Indications for Use (protection against bruxism, reduction of damage/noise from teeth grinding, for individuals 18+)
  • Device Description (boil-and-bite, self-fit mouthguard)
  • Predicate Device (Oral-B plus Scope Outlast Nighttime Dental Guard, K113326)
  • Comparison of Technological Characteristics (similarities in product code, classification, indications, intended use, anatomical site, molding, fit, reusability, biocompatibility, cleaning, labeling; primary difference being the absence of flavor in the new device)
  • Non-Clinical Testing (biocompatibility testing according to ISO standards)
  • Clinical Testing: "No clinical study was conducted."

Therefore, I cannot provide the requested information about acceptance criteria, study details for an AI/ML device, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, because this document is not about an AI/ML-driven device. It is about a traditional, physical dental device.

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