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1. Direct or indirect class III, IV, and V restorations.
2. Diastema closures.
3. Composite restorations bonded to tooth structure.
4. Composite restorations bonded to metal.
5. Composite restorations bonded to composite or fiber-reinforced substructure.
6. Composite restorations bonded to porcelain.
7. Direct or indirect veneers.

A-Wear™ provides the dentist with a composite designed to yield high resistance to wear and abrasion and excellent polishing characteristics. In addition to these properties, Aand ublighty translucent (opacity <40%). A- Wear™ is cured by heat and light and is designed to be used with high quality dentin/enamel adhesive systems.

The provided text is a 510(k) submission for a dental composite material called A-Wear™. While it provides information about the device's intended use and legal marketing status, it does not contain details about specific acceptance criteria and the studies that prove the device meets these criteria in the way you've outlined.

The document discusses the device's properties (high resistance to wear and abrasion, excellent polishing characteristics, translucent opacity) by description and comparison to a predicate device (Micronew™), but it does not present quantifiable acceptance criteria or study results to demonstrate these claims.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The information requested typically comes from performance testing sections of a submission, which are not present here.

However, I can extract the following limited information where available:

Acceptance Criteria and Device Performance (Based on descriptive claims, no quantitative data available):

Information not available in the provided text:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned. The document is a regulatory submission, not a study report.
• 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 for this type of device (dental composite) and information provided. Ground truth would typically be related to clinical outcomes or material property measurements, not expert consensus on images.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
• 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-powered diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned, but for a dental composite, ground truth would be based on validated material testing standards (e.g., ISO standards for wear, abrasion, translucency, bonding strength).
• The sample size for the training set: Not applicable. This is not a machine learning device.
• How the ground truth for the training set was established: Not applicable.

Summary of what is provided and what is not provided:

The provided text focuses on:

• Identifying the legally marketed predicate device (Micronew™).
• Describing the applicant device (A-Wear™) and its intended uses.
• Stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

It does not include the detailed technical study reports, material testing results, or clinical data that would typically contain the acceptance criteria and performance data you've asked for. This level of detail would be in supporting documentation within the full 510(k) submission, not typically in the summary or clearance letter provided.

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