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Pürzir Dental Zirconia blanks are used for dental restorations using different CAD / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

Pürzir Dental Zirconia are disc shaped zirconia oxide blanks made available in different versions and chemical compositions of various colors, shades and dimensions and sold to dental labs that will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using Computer Aided Drafting / Computer Aided Machining (CAD / CAM) equipment. The subject device is made available in six versions: 1. HS (High Strength), 2. HT (High Translucent), 3. HT Plus (High Translucent Plus), 4. ST (Super Translucent), 5. MMT x2 (Max Multi Translucent), and 6. MMT Plus x2 (Max Multi Translucent Plus).

The provided text is a 510(k) summary for the Pürzir Dental Zirconia device. It describes the device, compares it to a predicate device, and outlines the non-clinical performance testing conducted to demonstrate substantial equivalence. However, it does not contain the specific information required to complete the requested table and details about a study proving the device meets acceptance criteria related to AI or human reader performance.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of acceptance criteria and the reported device performance

The document mentions several performance tests were conducted in accordance with ISO 6872, but it does not explicitly state the acceptance criteria for each test or the reported performance values. It only broadly states "Results confirm that the design inputs and performance specifications for the subject device have been met."

To provide a complete table, I would require the specific acceptance limits for each test (e.g., minimum flexural strength, maximum chemical solubility) and the actual measured results for the Pürzir Dental Zirconia.

Example of how the table would look if the information were present:

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 states that "final finished samples of their device" were tested for non-clinical performance. However, it does not specify the sample size for these tests. It also does not provide any information about data provenance as these are laboratory performance tests of materials, not clinical data from patients.

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 information is not applicable and not present in the document. The testing described is non-clinical material performance testing (e.g., flexural strength, chemical solubility), which does not involve human experts establishing ground truth in the way a diagnostic AI study would.

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

This information is not applicable and not present in the document, as it pertains to human interpretation/assessment, not material property testing.

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

The document explicitly states: "Clinical testing on the subject device have not been performed." Therefore, no MRMC study was done, and no information about AI assistance or its effect on human readers is provided. This device is a dental material, not an AI-powered diagnostic tool.

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

This information is not applicable and not present in the document. The device is a physical dental material (zirconia blanks), not an algorithm or AI system.

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

For the non-clinical performance testing (ISO 6872 standards), the "ground truth" is defined by the objective measurement results according to the specified test methodologies outlined in the standards (e.g., using a universal testing machine for flexural strength, gravimetric analysis for chemical solubility). This is a laboratory measurement-based ground truth, not expert consensus, pathology, or outcomes data, as those are typically relevant for clinical or diagnostic studies.

8. The sample size for the training set

This information is not applicable and not present in the document. Since this is a physical dental material and not an AI/machine learning device, there is no "training set."

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

This information is not applicable and not present in the document, as there is no training set.

In summary, the provided FDA 510(k) summary is for a traditional medical device (dental zirconia blanks) and focuses on demonstrating substantial equivalence through non-clinical material performance testing and biocompatibility. The questions posed are largely geared towards the evaluation of AI-powered diagnostic devices, which is not the nature of the Pürzir Dental Zirconia.

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