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Luxer Shaded Zirconia blanks/discs are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (full contour crowns and bridges) as prescribed by a dentist.

Luxer Shaded Zirconia blanks are pressed and sintered blocks of Yttria stabilized Zirconia for use in CAD/CAM milling machines. It comes in different thicknesses (12 mm - 20 mm) and classic VITA shades A-D. In order to achieve pigmentation, four basic color components are used from the TOSOH TZ-Series of zirconia {white, yellow, pink, and gray} that yield corresponding VITA shades (A-D). After the Zirconia block is milled, it is sintered into a high strength all ceramic material suitable for full contour crowns and bridges. The material is biocompatible, has a high flexural strength (>1100 Mpa), and is water insoluble. These characteristics meet the ISO standard 6872 for an esthetic dental ceramic material.

The provided text describes the acceptance criteria and a study proving the substantial equivalence of the Luxer Shaded Zirconia device to a predicate device, as required for a 510(k) submission.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a distinct "test set" in the context of clinical or image-based studies. Instead, "non-clinical testing" was performed to validate the design and confirm conformance with ISO 6872:2008. The sample size for this non-clinical testing (e.g., number of specimens tested for flexural strength) is not explicitly stated.
• Data Provenance: The data comes from "non-clinical testing" and a "Standard Data Report (Form 3654)" in relation to ISO 6872. This indicates laboratory-based, retrospective testing of material properties rather than prospective clinical data. The country of origin of the data is not specified but is implicitly associated with the applicant, Continental Dental Ceramics, Inc. (USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable as the study described is a non-clinical, material properties comparison study for substantial equivalence, not a study involving expert assessment of images or clinical outcomes to establish ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable as the study described is a non-clinical, material properties comparison study, not one requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission focuses on the material properties and substantial equivalence of the zirconia blanks themselves, not on the performance of human readers with or without AI assistance.

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

• No, a standalone algorithm-only performance study was not done. This device is a dental material (zirconia blanks), not an algorithm or AI system.

7. The Type of Ground Truth Used

• The ground truth used for evaluating the device's properties (flexural strength, biocompatibility, solubility, etc.) was established through laboratory testing against the requirements of the international standard ISO 6872:2008 for dental ceramic materials and comparison to the known properties of the predicate device.

8. The Sample Size for the Training Set

• This information is not applicable. There is no "training set" as this is a material science and engineering validation, not a machine learning or AI study.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable for the reasons stated above.

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