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TALON and REVERE are a moldable acrylic compound for use in the fabrication, of TMJ/D Splints / Night Guards / Anti-Bruxism Guards / Mouth Guards / Sleep Apnea Anti-Snore Appliances / Liners, and/or Relines for Complete and Partial Dentures / Gaskets for Overdentures / and other dental prostheses device appliances as prescribed.

The submitted devices, TALON® and REVERE are a thermoplastic moldable acrylic compound for use in the fabrication, repair and relining of complete and/or partial dentures, dental appliances, and dental prostheses devices, including gaskets for over dentures, splints, night guards and sleep apnea anti-snore devices, and other appliances as prescribed.

The provided text describes a 510(k) premarket notification for two medical devices, TALON® and REVERE®, which are thermoplastic moldable acrylic compounds for dental use. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding AI/human reader studies, ground truth establishment, and specific sample sizes for training/test sets is not applicable to this type of regulatory submission.

However, based on the provided text, I can infer the acceptance criteria or performance characteristics expected of the device, and the evidence presented to demonstrate these characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence to existing predicate devices, the "acceptance criteria" are essentially the characteristics and performance attributes of the predicate devices. The study performed is a demonstration that the new devices (TALON® and REVERE®) possess these same characteristics.

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

• Test Set Sample Size:
  • Residual Monomer Level: Not explicitly stated, but gas chromatographic studies were performed.
  • Shore-D Hardness: Appliances after 1 year of continuous use compared to a new appliance. The number of appliances tested is not specified.
  • Biocompatibility Testing: Not explicitly stated for each test, but standard in-vitro (cytotoxicity) and in-vivo (sensitization, irritation) tests were performed using biological samples (guinea pigs, rabbits) as per ISO standards.
• Data Provenance:
  • Residual Monomer Level: Verified testing results completed through Gas Chromatographic studies performed by Cyro Industries of Orange, Connecticut.
  • Shore-D Hardness: Testing performed by Braun-Intertec of Portland, Oregon. TMJ/D appliances were used.
  • Biocompatibility Testing: Contracted with NAMSA, 9 Morgan, Irvine, California 92618. Samples of REVERE® were used, as it is identical to TALON® except for colorant.
  • Retrospective/Prospective: The testing described appears to be prospective validation testing conducted specifically for this submission.

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

• Residual Monomer Level: Experts at Cyro Industries (details not provided).
• Shore-D Hardness: Experts at Braun-Intertec (details not provided).
• Biocompatibility: Experts at NAMSA, a qualified testing laboratory.
• Other characteristics: The statement mentions "Consultation with Dr. Frances Storrs, MD. a dermatologist at Oregon Health Sciences University in Portland, Oregon whose area of research is contact dermatitis of acrylics, stated in her opinion I could not have selected a safer acrylic." This is an expert opinion, but not explicitly used to establish "ground truth" for the test set in the same way laboratory results are.

4. Adjudication method for the test set

Not applicable. The tests performed are objective laboratory and preclinical (animal) tests with defined endpoints, not subjective human assessments requiring adjudication.

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

Not applicable. This is a 510(k) submission for a dental material, not an AI-powered diagnostic device.

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

Not applicable. This is a material, not an algorithm or software.

7. The type of ground truth used

• Objective lab measurements: Gas chromatography for monomer levels, Shore-D hardness testing.
• Preclinical animal studies: Cytotoxicity via ISO elution method, ISO Maximization Sensitization Study (guinea pigs), ISO Vaginal Irritation Study (rabbits), ISO Skin Irritation Study (rabbits).
• Comparison to predicate device characteristics: The fundamental "ground truth" for substantial equivalence is that the new device shares the same fundamental technological characteristics and performs as safely and effectively as the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this type of material device submission, as it does not involve machine learning or AI.

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

Not applicable, as there is no training set.

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