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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

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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FENIIIIIX system includes the following 6 sets of stains and dental porcelains:

FENIIIIIX COLORATION KIT SN2000Y a porcelain stain system designed for easy application and natural fluorescent properties. This dental porcelain stain system can be used with most commercially available porcelain restorations where porcelain's ability to mimic natural tooth appearance is important. The system provides optimum esthetics with the most consistently reliable results for the full range of shades.

The FENIIIIIX COLORATION KIT stain system is ideal for high and low production laboratories and is available in 16 classic Vita® shades as well as Neutral Brown, Complex Gray, Blue Gray, Ochre; Rust and Red for matching bleached dentition with CTE Ranges of 13.7 to 15.1. The full assortment is 22 Stains, 1 powdered glaze and 1 liquid glaze.

The stains in the SN2000Y kit fire at 900ºC

• FENIIIIIX COLORATION KIT SN200Y is identical to the SN2000Y kit in function and content except that the stains in the SN2000Y kit fire at 750°C
  FENIIIIIX SUPER LIGHT WHITE KIT, a stain kit designed to produce perfectly white dental restorations. It includes one powdered stain and 1 liquid glazon

• FENIIIIIX SPEACIAL CLEAR KIT, This kit includes a series of whites designed to produce areas of whitish translucence and opalescence.

• ASTARTE SUPER WHITE PORCELAIN KIT. This kit is specifically designed to create perfectly white dental restorations and can be used with most commercially available base and precious metal, dental alloys that are designed for porcelain fused to metal applications. It includes 1 powdered opaque, 1 powdered enamel, 1 powdered colorless glaze, 1 liquid opaque and 1 liquid dentine.

• FENI///// ELIMINCRACK. This kit is used to repair cracks that form in porcelain dental restorations. It includes 1 powdered porcelain and 1 repair liquid.

Not Found

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification for a dental porcelain product named FENIIIIIIX. It describes the product's indications for use and states that it has been deemed substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to assessing the performance of a device using AI or human readers.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or any other details about studies as none of that information is present in the text you've provided.

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