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Transcend universal composite is used for direct restorations in both the anterior and posterior regions.

Transcend is a light cured, tooth shade resin composite material (Bis-GMA based) to be used for posterior and anterior tooth restorations. Transcend is radiopaque and available in a range of dentin, enamel, and body shades. It is 81% filled by weight and 58% filled by volume and has an average particle size of 0.9μm (by weight) with narrow upper limit particle distribution.

Composite Wetting Resin is a 45% filled, radiopaque light cured wetting resin. Composite Wetting Resin helps to improve the glide of the instrument during and contouring. It may be used during the placement of composite if the composite has become dry during incremental layering, or if the oxygen inhibition layer has been removed or disturbed. The wetting agent is an accessory and, if necessary, is used in conjunction with Transcend.

This is a medical device 510(k) summary for a dental restorative material, not data from a study that fits the requested format for acceptance criteria of an AI/ML device. Therefore, the requested information elements such as sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, and ground truth establishment for training and test sets are not applicable or provided in this document content.

The provided text describes a "Transcend" tooth shade resin material and an accessory "Composite Wetting Resin." The document states that "before marketing the device, testing has been conducted to meet specified acceptance criteria." However, it does not provide specific numerical acceptance criteria or the reported device performance in a tabular format that is clearly tied to meeting those criteria, as typically seen for AI/ML device performance studies.

Instead, the document primarily focuses on demonstrating substantial equivalence to a predicate device (Amelogen Plus) and reference device (SeamFree) through comparisons of technological characteristics, intended use, composition, delivery systems, physical properties, shelf life, and adherence to relevant ISO and ADA standards.

Here's an attempt to extract relevant information, acknowledging that it doesn't align with the typical structure for AI/ML device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device was tested against standards, and the results were within acceptable limits. It does not provide specific numerical acceptance criteria or reported values for each property.

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

• Sample Size: Not specified. Standard testing for material properties typically involves multiple samples for reproducibility, but the exact number is not detailed in this summary.
• Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer or a third-party testing facility.

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

• Not applicable/Not provided. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is adherence to established material science standards.

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

• Not applicable/Not provided. The compliance is against defined material property standards, not subjective clinical 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 dental material, not an AI/ML diagnostic or assistive device.

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

• Not applicable. This is a dental material.

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

• The "ground truth" in this context is defined by the requirements of the standards: ISO 4049:2019 (Dentistry – Polymer-based restorative materials) and ANSI ADA 27-2016 (Polymer-based Restorative Materials) for physical properties, and ISO 10993-1:2018 for biocompatibility.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device.

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