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The DenTek Ultimate™ Dental Guard is indicated 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 DenTek Ultimate™ Dental Guard is a one-piece, posterior-occlusion dental guard consisting of two moldable bite-pads connected by a flexible band that rests behind the user's front teeth. The guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by molding the bite pads to the user's maxillary pre-molars after the guard has been heated via submersion in boiled water. The DenTek Ultimate™ Dental Guard is supplied pre-loaded into a flexible molding tray that allows the user to accurately place and comfortably hold the heated device during the molding process. When in place, the guard maintains separation between upper and lower teeth, reducing noise and damage to the teeth associated with teeth grinding.

This document describes the regulatory submission for the DenTek Ultimate™ Dental Guard (K180933). The review confirms substantial equivalence to a predicate device, the DenTek™ Custom Comfort Nightguard Version 2 (K091660), for the indication of protecting against bruxism or nighttime teeth grinding.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerically-defined thresholds. Instead, it describes performance characteristics that the device was tested against to demonstrate substantial equivalence to its predicate. The "reported device performance" is essentially that the device performed sufficiently in these tests to meet the subjective goals of the tests and support its intended use.

Here's a breakdown of the performance data reported (which served as evidence of meeting implied "acceptance criteria" for substantial equivalence):

2. Sample Size Used for the Test Set and the Data Provenance

The document refers to "simulation studies" for the impression, separation, stability, and comparative wear tests. It does not explicitly state the sample size (e.g., number of guards tested, number of simulated applications) or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that these were "simulation studies." For the biocompatibility tests, specific ISO standards are cited, which typically involve standardized methods and sample sizes for the biological material/animals used, but the specific number used in this particular study is not given.

Given the nature of the device (over-the-counter dental guard) and the type of submission (510(k) for substantial equivalence), in-depth clinical trials with large human test sets are often not required if technical and bench testing is sufficient to demonstrate similarity to a predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for the non-clinical performance tests. These were likely evaluated based on objective measurements or observations by trained technicians or engineers involved in the testing, adhering to predefined protocols for each simulation.

For the biocompatibility tests, the ground truth is established by the results of the standardized assays themselves, interpreted by qualified personnel in toxicology/biocompatibility, but their specific number or qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

No adjudication method is described for the "test set" (which consists of bench tests and biocompatibility assays). The outcomes of these tests are direct results from the experimental setup, rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. The DenTek Ultimate™ Dental Guard is a physical medical device for protection against bruxism, not a diagnostic tool requiring human reader interpretation in the same way.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The DenTek Ultimate™ Dental Guard is a physical medical device, not an algorithm or AI system. Therefore, "standalone" algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used

For the impression, separation, stability, and comparative wear tests, the "ground truth" would be the objective physical performance observed during the simulation studies. For instance, whether an impression was "distinct" would be based on visual criteria, whether teeth were "separated" would be a physical measurement, and "durability" would be assessed against expected wear characteristics.

For the biocompatibility tests, the ground truth is established by the biological response of cells (cytotoxicity) or animals (sensitization, irritation) as measured and interpreted according to the specific ISO standards.

8. The Sample Size for the Training Set

This question is not applicable. The DenTek Ultimate™ Dental Guard is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable. As stated above, there is no "training set" for this device.

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