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Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues. For Use only by a Licensed Dentist. Rx Use Only.

Triumph Resin Dam is a light-cured, resin dam material recommended to block out or protect dental materials or tissues. Triumph contains polymerizable monomers that when light-cured form a protective barrier. When set the resin has a low strength allowing its removal from the protected surfaces.

This document is a 510(k) summary for a medical device called "Triumph Resin Dam," which is a resin-based, light-cured protective barrier material for dental use. The summary focuses on demonstrating substantial equivalence to a predicate device ("OpalDam") rather than presenting a study proving performance against acceptance criteria in the typical sense of a clinical trial for diagnostic AI.

However, I can extract the relevant information from the document to construct an answer aligned with your request, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence and "study" as the comparison tests performed.

Here's a breakdown of the requested information based on the provided text:

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

For this type of device (a Class I dental resin dam), the "acceptance criteria" are essentially the characteristics and performance deemed equivalent to a legally marketed predicate device. The document primarily focuses on demonstrating substantial equivalence to the Opal Dam (K971284) and referencing BriteSmile (K010935) for hardness comparison.

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

This document does not describe a "test set" in the context of diagnostic performance typically associated with AI. The evaluations are for biocompatibility and physical/mechanical properties.

• Biocompatibility Tests (Cytotoxicity, Human Skin Irritation, Skin Sensitization): Standardized tests (ISO 10993) were performed. The sample sizes for these specific tests are not detailed in this summary but would be defined by the ISO standard. The provenance of the data is not specified beyond being generated for this submission.

• Physical/Mechanical Properties (Hardness, Depth of Cure, Setting Time): These are laboratory measurements. Sample sizes are not specified for each measurement, but they would be conducted on samples of the device material. Data provenance is not further detailed.

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)

This is not applicable to the evaluation of this device. The "ground truth" for biocompatibility is established by the standardized methods of ISO 10993, and for physical properties by laboratory testing procedures. There are no "experts" establishing conventional ground truth in the sense of clinical diagnoses.

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

Not applicable. There is no adjudication method described as this is not a diagnostic study involving human interpretation.

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 device is a physical dental material, not an AI or diagnostic tool, and therefore no MRMC study was performed.

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

Not applicable. This device is a physical dental material, not an algorithm.

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

The "ground truth" for this device's evaluation relies on:

• Standardized Biological Evaluation Protocols: For biocompatibility, ISO 10993 serves as the "ground truth" framework.
• Physical/Chemical Measurement Standards: For properties like setting time, depth of cure, and hardness, these are determined through established laboratory measurement techniques, often against internal specifications or industry standards.
• Comparison to Predicate Device: The primary "ground truth" for regulatory clearance is demonstrating that the device is substantially equivalent to a legally marketed predicate, meaning it performs similarly and raises no new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This device is a physical dental material, not an AI model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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