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The Custom Comfort Nightguard Version 2 is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The Custom Comfort Nightguard Version 2 is a fully occlusive nightguard, consisting of a soft, formable material, and non-formable base, which cushions the teeth. When heated and then briefly cooled, the formable material is molded to fit the user's maxillary dentition for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces.

This document is a 510(k) summary for a medical device (Custom Comfort Nightguard Version 2). It indicates that the device has undergone no new clinical studies and instead relies on substantial equivalence to previously cleared predicate devices.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance criteria and reported device performance (no new performance data presented)
• Sample size for the test set and data provenance
• Number of experts and their qualifications for establishing ground truth
• Adjudication method for the test set
• MRMC comparative effectiveness study results or effect size
• Standalone algorithm performance
• Type of ground truth used (for a new study)
• Sample size for the training set
• How ground truth for the training set was established

Explanation:

The document explicitly states its purpose is a "Special 510(k) notice" for a "modification" to existing devices. It concludes that "The minor modifications made to the device do not raise any new questions of safety or effectiveness. Thus, the Custom Comfort Nightguard Version 2 is substantially equivalent to its predicate devices." This means the FDA did not require new performance data or clinical studies for this submission. The device's safety and effectiveness are assumed based on its similarity to previously cleared devices.

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The Custom Comfort Nightguard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The Custom Comfort Nightguard is a fully occlusive nightguard, consisting of a soft, formable material, and non-formable base, which cushions the teeth. When heated and then briefly cooled, the formable material is molded to fit the user's maxillary dentition for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces. The Custom Comfort is designed with an anterior area formed from the soft, formable material that allows for expansion and contraction of the device to fit most mouth sizes.

This is a 510(k) premarket notification for a medical device called "Custom Comfort Nightguard." The document explicitly states that it is a modification to a previously cleared device, the "DenTek Nightguard (K063483)," and claims "The minor modification made in the device does not raise any new questions of safety or effectiveness."

Therefore, this submission does not contain a study proving the device meets acceptance criteria. Instead, it relies on the concept of substantial equivalence to a predicate device already on the market. In 510(k) submissions, especially for modifications of existing devices that do not introduce new questions of safety or effectiveness, often no new clinical studies or detailed performance studies with acceptance criteria are required or performed. The FDA determines substantial equivalence based on the comparison of intended use, indications for use, technological characteristics, and safety and effectiveness information.

Given this context, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory submission for a Class I unclassified device (Over-the-Counter Mouthguard), where rigorous performance study data as typically seen for higher-risk devices or novel technologies is generally not required for clearance.

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