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• Class V restorations (Cervical caries, root caries, wedge-shaped defects)
• Covering of exposed or discolored necks of teeth
• Restoration of esthetic appearance of gingival areas

Not Found

Here's an analysis of the provided text regarding acceptance criteria and study details:

The provided document is an FDA 510(k) clearance letter for a dental device (Beautifil II Gingiva) and its Indications for Use. It does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials or performance studies with specific acceptance criteria in the manner often seen for novel AI/medical imaging devices.

Therefore, many of your requested points cannot be answered from this document.

However, I can extract the following based on the nature of the document:

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

• Not available in this document. This document is a clearance letter, not a performance study report. For a dental restorative material like this, acceptance criteria would typically involve physical, chemical, and biological properties (e.g., flexural strength, wear resistance, biocompatibility, color stability) established through ISO standards or similar benchmarks. The document doesn't detail these or the device's specific performance against them.

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

• Not available in this document. This document does not describe a test set or data provenance from a device performance study.

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/available in this document. This document does not pertain to an AI device or a study requiring expert ground truth establishment for a test set.

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

• Not applicable/available in this document.

5. If a multi-reader multicase (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/available in this document. This is a dental restorative 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/available in this document.

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

• Not applicable/available in this document. For dental materials, the "ground truth" for demonstrating substantial equivalence often relies on adherence to material standards and potentially in-vitro or ex-vivo testing, rather than clinical ground truth as defined for diagnostic devices.

8. The sample size for the training set

• Not applicable/available in this document. This document does not describe a training set as it's not an AI device.

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

• Not applicable/available in this document.

Summary of what the document DOES provide:

• Device Name: BEAUTIFIL II Gingiva
• Regulatory Status: 510(k) cleared, Class II (Special Controls)
• Regulation Number/Name: 21 CFR 872.3690 / Tooth Shade Resin Material
• Product Code: EBF
• Indications for Use:
  • Class V restorations (Cervical caries, root caries, wedge-shaped defects)
  • Covering of exposed or discolored necks of teeth
  • Restoration of esthetic appearance of gingival areas
• Type of Use: Prescription Use
• Predicate Device Information: While not explicitly named in this letter, the 510(k) process is based on demonstrating substantial equivalence to a legally marketed predicate device. The actual submission (K151700) to the FDA would contain details about the predicate.

To obtain the detailed performance data, acceptance criteria, and specific study reports, one would typically need to refer to the full 510(k) submission (K151700) available through the FDA's public database, or directly from the manufacturer if they publish such data. The clearance letter itself is a regulatory outcome, not a detailed technical report.

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