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InSync ZR High Translucency Zirconia blanks are intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures.

InSync ZR High Translucency Zirconia is a y-tzp (yttria stabilized tetragonal zirconia polycrystals) material that features very high translucency. It is intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units using CAD/CAM technology. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures. InSync ZR High Translucency Zirconia meets requirements for Class 5 (type II) ceramics when tested according to ISO 6872:2008.

This document describes a medical device submission (K142043) for InSync ZR High Translucency Zirconia. It is a 510(k) Summary for a dental ceramic. The document asserts the device's substantial equivalence to a predicate device (NexxZr T; K130991).

Here's a breakdown of the requested information based on the provided text:

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

2. Sample sized 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 sample sizes for non-clinical testing. It also does not provide information on data provenance (country of origin, retrospective/prospective). The testing focused on physical properties (flexural strength, chemical solubility) to confirm adherence to ISO 6872:2008.

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 device is a dental material, not an AI or diagnostic device that relies on expert interpretation of data. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not applicable to this submission. The ground truth for material properties is established by adherence to international standards (ISO 6872:2008) and testing methodologies described within those standards.

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

Not applicable. This is not a diagnostic device requiring adjudication of interpretations.

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

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is a material, not an algorithm.

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

The "ground truth" for this device's performance is adherence to the physical and chemical property requirements of ISO 6872:2008 for a Class 5 (type II) ceramic.

8. The sample size for the training set

Not applicable. This is a material, not a machine learning model that requires a training set. The "development" of the material itself is a chemical/engineering process, not an AI training process.

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

Not applicable. As above, this is a material, not a machine learning model.

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