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The Rest Assured Generation II Dental Protector is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The Rest Assured II is a fully occlusive nightguard, fitted to the patient by the "boil and bite" method.

This 510(k) summary (K091792) for Ranir, LLC's Rest Assured Generation II Dental Protector does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving the device meets them. This document is a Summary of Substantial Equivalence, which focuses on demonstrating that the new device is as safe and effective as previously cleared predicate devices. It does not typically include a de novo clinical study with detailed acceptance criteria and performance metrics in the way you've outlined for diagnostic AI products.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be extracted. This document is a 510(k) summary, not a clinical trial report. It asserts substantial equivalence based on similar intended use and technological characteristics to predicate devices. It does not provide specific performance metrics in the way a diagnostic device would (e.g., sensitivity, specificity, accuracy).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be extracted. No test set or study data is presented in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be extracted. No ground truth establishment or expert review is described.

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

• Cannot be extracted. No adjudication method is mentioned as no test set is detailed.

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

• Cannot be extracted. An MRMC study is not mentioned. This device is a physical dental protector, not an AI-assisted diagnostic tool.

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

• Cannot be extracted. This is not an algorithm-based device.

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

• Cannot be extracted. No ground truth is described.

8. The sample size for the training set

• Cannot be extracted. No training set for an algorithm is mentioned.

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

• Cannot be extracted. No training set or ground truth establishment relevant to an algorithm is mentioned.

Summary regarding acceptance criteria and study for K091792:

The provided document (K091792) is a 510(k) summary for a physical medical device (dental protector), not an AI-based diagnostic tool. The submission strategy relies on substantial equivalence to predicate devices. This means that the device's safety and effectiveness are established by demonstrating that it has the same intended use, similar technological characteristics, and principles of operation as legally marketed devices, and that any minor differences do not raise new questions of safety or effectiveness.

Therefore, the submission does not contain a study with detailed performance metrics, test sets, or ground truth establishment as would be expected for a diagnostic or AI-driven medical device. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence to the predicate devices (Ranir, LLC's Rest Assured Night Protector (K063229) and Prestige Brands, Inc.'s Doctor's Nightguard Advanced Comfort Fit (K073220)), which the FDA confirmed the device met.

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