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The LIJIA Night Guard is indicated for protection of teeth and restorations against grinding and clenching.

The LIJIA Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).

This document is a 510(k) Premarket Notification from the FDA regarding the LIJIA Night Guard. It states that no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the device due to similarities in indications for use, technological characteristics, and non-clinical performance testing validated against a predicate device.

Therefore, there is no information available in the provided text about acceptance criteria for device performance, the study that would prove the device meets these criteria, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or sample sizes for training sets.

The document focuses on the substantial equivalence determination for the LIJIA Night Guard based on non-clinical performance testing and comparison to predicate devices, rather than a clinical study demonstrating performance against specific acceptance criteria.

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