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TEMP MASTER, PMMA-based dental resin developed by Taiwan Dental Materials CO., LTD. is a self-cured resin indicated for the fabrication of short-term restorations including temporary inlays, crowns, and bridges, which can protect or restore damaged teeth while permanent restorations are being prepared. It is a traditional auto-cured PMMA-based resin composed of powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature.

TEMP MASTER, PMMA-based dental resin, is a self-curing (cold-cure) material designed to fabricate temporary crowns and bridges. It consists of two components: powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature. Classified as a Type 1 (autopolymerizable) acrylic resin according to ISO 10477 standards, TEMP MASTER, PMMA-based dental resin provides reliable performance for temporary restorations.

This document describes a 510(k) premarket notification for a dental material, not an AI/ML powered device. Therefore, much of the requested information regarding AI/ML device studies (such as sample sizes for test and training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable.

However, I can extract the acceptance criteria and reported device performance based on the provided bench testing information for the TEMP MASTER, PMMA-based dental resin.

Here's the information as it relates to the provided document:

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

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

• Sample Size: The document does not specify the exact sample sizes used for the bench tests. It only states that "the nonclinical tests conducted in accordance with ISO 10477 assessed the flexural strength, water sorption, and water solubility."
• Data Provenance: The bench testing was performed to support the 510(k) submission from "Taiwan Dental Materials CO., LTD." The data would therefore originate from Taiwan, likely conducted prospectively for regulatory submission.

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)

Not applicable. This is a dental material, and the performance is evaluated through objective physical and chemical bench testing against international standards (ISO 10477). There were no human experts involved in establishing a "ground truth" in the way it's understood for AI/ML diagnostic devices.

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

Not applicable. As this involves physical/chemical testing, there is no "adjudication method" in the context of human interpretation or consensus. The tests would be performed according to standardized protocols and the results measured objectively.

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 medical device (dental material), not an AI/ML algorithm requiring human interpretation.

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

Not applicable. This is a medical device (dental material), not an AI/ML algorithm.

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

The "ground truth" for the device's performance is established by international standards for dental materials (ISO 10477). These standards define the acceptable ranges and methodologies for evaluating physical and chemical properties like flexural strength, water absorption, and water solubility.

8. The sample size for the training set

Not applicable. This is a medical device (dental material), not an AI/ML algorithm that requires a "training set."

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

Not applicable. This is a medical device (dental material), not an AI/ML algorithm.

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