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The Thermoformed Mouthguards are intended for protection against bruxism and nighttime teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.

The Thermoformed Mouthguards/Nightguards are designed to alleviate the pain and damage caused by bruxing or clenching of the teeth. These customized devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching while protecting teeth from daily wear and tear. The design of Thermoforming Mouthguards/Nightguards is the same, and the only difference is the material in terms of hardness, softness or semi-softness. Each Mouthguard/Nightguard is made with a standard flat occulusal plane and slight opposing cusp indentation to each patient's specific bite plane needs that could be determined by a dentist after diagnosis of bruxism. The Comfort H/STM Hard Soft Bite Splint is the most widely prescribed bite splint due to its comfort and fit. The soft internal surface rests comfortably against the teeth and gums, while the hard occlusal surface provides durability and bonds. Thermoformed Mouthguards/Nightguards are manufactured from biocompatible materials.

This document is a 510(k) summary for Thermoformed Mouthguards/Nightguards submitted by Glidewell Laboratories-Sleep Devices Group to the FDA. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving performance against acceptance criteria for a novel device.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria (including details like sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not present in the provided text.

The document primarily addresses the following:

1. Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new device's performance. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, indication for use, material, design, and performance.
• Reported Device Performance:
  • Material Properties Comparison (Table on page 2):

    Product	Melting Point	Density	Hardness Shore	Tensile Strength
    Glidewell Laboratories-Sleep Devices Group	>72 °C	> 0.92	> 82/	> 15
    Elvax (Predicate Material example used for comparison)	>72 °C	> 0.92	> 82/	> 15

  • Biocompatibility: The document states that the materials are "BPA-free and are approved for dental use. The biocompatibility of the materials is confirmed according to DIN/EN 30993-1." It also mentions "two test reports for Cytotoxicity" whose summary indicates "thermoformed materials do not release substances in cytotoxic concentrations during a permanent 24 h contact of 4.5 cm- surface area to 1 ml physiological fluid."

The following information is NOT available in the provided text:

2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set requiring ground truth is described.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This document describes a physical medical device (mouthguard), not an AI system or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

(Self-Correction): The request specifically asks for acceptance criteria and the study that proves the device meets the acceptance criteria. The provided document explains the basis for substantial equivalence to predicate devices for regulatory approval, which is a different type of "proof." It relies on material properties, biocompatibility testing (cytotoxicity), and comparison of design and intended use with existing devices. It does not present a performance study with defined acceptance criteria and results from a clinical or analytical study in the way a novel diagnostic or AI device might.

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