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The New Comfort-Fit® Dental Guard is indicated for use for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

The New Comfort-Fit® Dental Guard is a posterior-only occlusion dental guard, consisting of two bite pads connected by a buccal retention strap. The New Comfort-Fit® consists entirely of ELVAX, a thermoplastic material. The bite pads move along the buccal strap in order to adjust to the individual user needs, with the strap always contained within the walls of the bite pads. There are 5 positions of adjustability for each bite pad. Bumpers on the lingual wall of the bite pads keep the pads from rubbing against the lower gum line. The upper vertical bite pad wall creates a greater surface area for the cheek to rest against, providing enhanced retention for the guard.

The provided text is a 510(k) Summary for a dental guard, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with performance metrics. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from this document.

This 510(k) submission is for a "Special 510(k)," indicating minor modifications to an already cleared device. The key argument is that "The minor modifications made to the device do not raise any new questions of safety or effectiveness." This type of submission generally relies on comparing technological characteristics and intended use to a predicate device, rather than new clinical performance data.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

• Cannot be provided. The document does not specify quantitative acceptance criteria or report performance data against such criteria. The basis for clearance is "substantial equivalence" to predicate devices, not meeting specific performance benchmarks in a study.

2. Sample size used for the test set and the data provenance:

• Cannot be provided. No clinical test set data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Cannot be provided. No test set requiring expert ground truth is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Cannot be provided. No test set is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Cannot be provided. This device is a physical dental guard, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI improvement metrics are not applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Cannot be provided. This device is a physical dental guard, not an algorithm. Standalone performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Cannot be provided. No ground truth data is discussed. The device's safety and effectiveness are established by demonstrating similarity to predicate devices.

8. The sample size for the training set:

• Cannot be provided. No training set for an algorithm is mentioned as this is a physical device.

9. How the ground truth for the training set was established:

• Cannot be provided. No training set is mentioned.

Summary of Device Information Available:

• Device Name: New Comfort-Fit® Dental Guard
• Intended Use: Protection against bruxism or nighttime teeth grinding; intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
• Technological Characteristics: Posterior-only occlusion dental guard, two bite pads connected by a buccal retention strap, made of ELVAX (thermoplastic material), adjustable (5 positions), with lingual wall bumpers and an upper vertical bite pad wall for enhanced retention.
• Predicate Devices:
  • DenTek Oral Care Inc.'s Improved Comfort-Fit NightGuard (K081669)
  • Sleepright® Dura-Comfort® Dental Guard (K071404)
• Basis for Clearance: Substantial equivalence to predicate devices, arguing that minor modifications do not raise new questions of safety or effectiveness.

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