(212 days)
BRUX MOUTHGUARDS are indicated to help protect the teeth from damage caused by bruxism, sports injuries, and muscle contractions.
BRUX MOUTHGUARDS are polymer trays that are used intraorally over the dentition. Two models are to be offered for upper (BRUX NIGHT), or lower (BRUX SPORT) dentition.
The provided text describes a 510(k) summary for BRUX MOUTHGUARDS. This submission primarily focuses on establishing substantial equivalence to a predicate device and includes biocompatibility testing. It does not contain information typically associated with studies proving acceptance criteria for AI/ML-powered medical devices, such as performance metrics (sensitivity, specificity, AUC), sample sizes for test sets, expert-derived ground truth, or comparative effectiveness studies.
Therefore, many of the requested fields cannot be answered from the provided text.
Here's a breakdown of what can be answered based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-cytotoxic | Non-cytotoxic |
| Non-oral irritant | Non-oral irritant |
| Non-skin sensitizer | Non-skin sensitizer |
Explanation: The acceptance criteria for BRUX MOUTHGUARDS, as implied by the testing performed, focused on biocompatibility. The reported performance confirmed that the material met these criteria.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The "test set" in this context refers to the biological samples used for biocompatibility testing, not a dataset for an algorithm. The specific number of samples for cytotoxicity, oral irritation, and skin sensitization tests is not provided.
- Data Provenance: Not specified, but these are standard in-vitro and in-vivo (animal) biocompatibility tests conducted according to ISO 10993 guidelines.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Biocompatibility testing results are typically interpreted by laboratory personnel and toxicologists/biocompatibility specialists, not "experts" in the sense of clinical reviewers establishing ground truth for an AI algorithm.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Biocompatibility test results are typically determined by established laboratory protocols and readings, not by an adjudication process as understood in clinical studies for algorithm evaluation.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical mouthguard, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: No, a standalone algorithm performance study was not done. This device is a physical mouthguard.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" here is the biological response observed in biocompatibility tests (e.g., cell viability for cytotoxicity, tissue reaction for irritation).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
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