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21st CENTURY ALLOY is a dental alloy designed for stress-bearing Class 1 and Class 2 restorations.

21st CENTURY ALLOY is a lathe cut, silver-based dental amalgam alloy designed for stress-bearing Class 1 and Class 2 restorations.

This 510(k) summary for DENTSPLY's 21st CENTURY ALLOY is quite old (1997) and for a dental amalgam alloy, not a software device or a diagnostic device typically associated with AI/ML and the detailed performance studies described in your query.

Therefore, much of the requested information, such as multi-reader multi-case studies, ground truth establishment methodologies for image data, and AI-specific metrics, is not applicable to this submission.

However, I can extract the closest analogous information based on the provided text.

Acceptance Criteria and Device Performance for 21st CENTURY ALLOY (Dental Amalgam Alloy)

Study Details and Data Provenance (Non-Applicable/Inferred for a 1997 Dental Amalgam)

1. Sample sizes used for the test set and the data provenance: Not explicitly stated. For material testing of this nature, samples of the alloy would have been manufactured and then subjected to the various biocompatibility tests. The provenance is internal to the manufacturer's testing or contracted labs (assumed for a 1997 submission), and would be prospective testing of the manufactured alloy. It's not "data provenance" in the sense of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For material performance and biocompatibility tests like these, "ground truth" is established by the results of standardized laboratory tests and expert interpretation of those lab results (e.g., toxicologists, histopathologists). The specific number and qualifications of experts are not reported in this summary.

3. Adjudication method for the test set: Not applicable. This refers to the process of resolving discrepancies in expert interpretations, common in diagnostic image analysis. For material testing, results are typically quantitative or qualitative based on established protocols.

4. 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 for AI/ML diagnostic devices. This device is a dental restorative material.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical material, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For biocompatibility, the ground truth would be based on standardized laboratory test results interpreted by qualified scientific and medical professionals (e.g., assays for cytotoxicity, animal models for oral toxicity and pulpal irritation). For material equivalency, it relies on elemental analysis and comparison to known compositions of predicate devices, coupled with historical evidence of safety and effectiveness for those materials.

7. The sample size for the training set: Not applicable. There is no training set for a traditional material like this in the context of machine learning. The "training" in a broader sense comes from decades of historical use and scientific understanding of amalgam alloys.

8. How the ground truth for the training set was established: Not applicable. As above, no training set in the AI sense. The "ground truth" for the principles behind the material's composition and use is established through long-standing dental material science, clinical consensus, and regulatory standards for such restorative materials.

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