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ZirDent™ CAD/CAM Blocks are pre-formed ceramic dental blanks intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations (porcelain teeth).

ZirDent is a pre-formed machineable dental blank composed of zirconia ceramic (yttrium oxide stabilized zirconium oxide [YZTP]]. ZirDent is available in green (meaning "unfired") pre-formed blanks, partially-sintered (partially fired) pre-formed blanks and fully sintered (including hot isostatic press) pre-formed blanks. ZirDent is available in different shapes, shades, and dimensions according to the customers' / dental laboratories' specifications.

The provided text describes the 510(k) summary for the ZirDent™ CAD/CAM Blocks, a dental restorative material. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and testing against specific metrics. Therefore, the information needed to fully answer the request is not present in the provided document.

However, I can extract the available information and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on available text):

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

• The document does not specify the sample size used for any testing.
• The document does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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)

• This type of information is not applicable to this submission. The submission is for a material, not a diagnostic or AI device that requires expert ground truth for interpretation. The "ground truth" for a material would typically be established by standardized material testing methods and physical property measurements.

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

• This is not applicable as the study is not an interpretative study requiring human adjudication of results.

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

• No MRMC comparative effectiveness study was done. This is a submission for a dental material, not an AI or diagnostic device.

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

• This is not applicable as this is not an AI or algorithm-based device.

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

• For a material, the "ground truth" for performance would be established by standardized material testing methods (e.g., ISO 6872 for dental ceramics) to measure physical and mechanical properties. The text states "Testing (including ISO 6872) confirms ZirDent is as safe and effective as the predicate devices," indicating that these standardized tests were the basis for evaluating "ground truth" regarding material properties.

8. The sample size for the training set

• This is not applicable as there is no mention of a "training set." This device is a ceramic material, not an AI or machine learning algorithm that requires training data.

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

• This is not applicable as there is no training set for this type of device.

Summary of what the document does provide regarding the study:

• Study Type: The study was a substantial equivalence testing against predicate devices, specifically involving "Testing (including ISO 6872)." ISO 6872 is a standard for dental ceramics, indicating that physical and mechanical properties were evaluated.
• Conclusion: The testing led to the conclusion that "ZirDent is as safe and effective as the predicate devices noted in this submission."
• Predicate Devices: Katana Zirconia (K050160), ZirBlank PS & FS (K070045), Zerion (K061804), Xavex-G100 (K050903).

To fully answer the request, more detailed technical documentation of the testing performed for the 510(k) submission would be needed, including specific test methods, sample sizes for those tests, and the numerical results compared against acceptance criteria defined by the ISO 6872 standard or other relevant material standards.

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