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Bright Guard is a mouth guard intended to protect against grinding and clenching. For over-the-counter use.

Bright Guard is comprised of a mouth guard, spatula and storage case. The mouth guard is an over-the-counter, flexible and moldable one-piece dental mouth guard, which is used as a barrier between teeth for individuals who grind their teeth. Bright Guard mouth guard is intended to be worn while sleeping. The mouth guard material is conformable to wear, and it can be self-fit by the 'boil and bite' method (submerging in hot water to make the material malleable to fit on the upper teeth of the oral cavity). Bright Guard mouth guard is constructed of 100% Thermoplastic resin Propylene Elastomer (TPE) material (ethylene-vinyl-acetate) [Elvax]. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. Bright Guard does not contain Bisphenol A (BPA) or phthalates and is free of natural rubber latex. The spatula and storage case are composed of 100% Polypropylene. The materials in Bright Guard are used in various other 510(k) cleared dental mouth guards. The three components (mouth guard, spatula and storage case) are manufactured by injection molding. Bright Guard mouth guard Is provided in 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) Summary for a medical device called "Bright Guard," a mouth guard intended to protect against grinding and clenching. It outlines the device's characteristics, its comparison to predicate devices, and the non-clinical performance data used to demonstrate substantial equivalence.

However, the provided document does not describe acceptance criteria for a study, nor does it detail a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device submission (e.g., accuracy, sensitivity, specificity, or human performance improvement with AI assistance).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices based on material composition, functional design, intended use, and non-clinical performance tests (biocompatibility and functional tests). There is no mention of an AI algorithm, a test set for AI, ground truth establishment by experts, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text does not contain such information for an AI/ML device.

The document explicitly states:

• "There were no clinical tests performed or provided in this submission." This means no human subject studies were conducted to assess clinical efficacy or performance.
• The performance data provided relates to "functional non-clinical performance tests" (Hardness, Water Sorption and Solubility, Spatula & Mouth guard Boiling/Cooling Water Testing) and "biocompatibility assessment" (Cytotoxicity, Skin Sensitization, Oral Mucosal Irritation). These are material and safety tests, not performance metrics like accuracy, sensitivity, or human-AI reader improvement.

Based on the provided information, the device is a simple "boil and bite" mouth guard, not an AI-powered device. Therefore, the questions related to AI/ML device testing (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, effect size of AI assistance) are not applicable to this submission.

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