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The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

BruxZir" Anterior Blanks are zirconia milling blanks that are used for the production of highly esthetic full-contour zirconia dental restorations. The high esthetics of BruxZir" Anterior makes it ideal for use in the anterior region. The manufactured full contour dental restorations are made utilizing the CAD/CAM system for design and manufacture. The designed and manufactured full-contour dental restorations are then sintered at a high temperature. BruxZir" Anterior White will have to undergo color alteration prior to sintering (colorants not provided by Prismatik). No color needs to be added to preshaded BruxZirTM Anterior Blanks (150, 250, 350, 450, 550) before sintering. Basic staining and glazing techniques need to be used after sintering to achieve the desired shade. The sintered material exhibits maximum strength and translucent pearlescence.

The provided document is a 510(k) premarket notification for a dental device called "BruxZir™ Anterior". This submission aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove that the device meets specific performance criteria through a standalone study with acceptance criteria.

The document does not contain a detailed study with acceptance criteria and reported device performance in the manner requested. Instead, it focuses on demonstrating equivalence to a previously cleared device.

However, I can extract the relevant information and structure it to best answer your request based on the content available.

Here's a breakdown of what can and cannot be provided:

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

The document primarily uses a comparison table (Table 1) to show similarity between the proposed device (BruxZir™ Anterior) and the predicate device (BruxZir™ Shaded - K130924). The "acceptance criteria" are implied by the predicate's established performance and regulatory classification. The "reported device performance" is often stated as "Same" indicating it meets these implied criteria.

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 "Non-clinical test data was used to support the substantial equivalency" and mentions "performance testing (flexural strength, translucency, shades/color consistency and the coefficient of thermal expansion (CTE))" and "biocompatibility".

• Sample Size: The specific sample sizes for these tests are not provided in this document.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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 therefore not available in the document. The testing described is primarily physical and chemical characterization of a dental material, not interpretation of medical images or diagnostic assessment by experts.

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

This information is not applicable and therefore not available in the document. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment, which is not the focus of this 510(k) submission.

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:

This information is not applicable and therefore not available in the document. This is a submission for a dental material (zirconia milling blanks), not an AI-powered diagnostic device.

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

This information is not applicable and therefore not available in the document. This is not an algorithm, but a physical dental material.

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

For the non-clinical testing mentioned (flexural strength, translucency, shades/color consistency, CTE, biocompatibility), the "ground truth" would be established by:

• Standardized Test Methods: Adherence to established international standards (e.g., ISO 6872 for flexural strength) or recognized material testing protocols.
• Material Specifications: Comparison against known physical and chemical properties of the predicate material and general scientific principles for dental ceramics.
• Biocompatibility Standards: Adherence to biocompatibility testing standards to confirm non-toxicity.

8. The sample size for the training set:

This information is not applicable and therefore not available in the document. There is no "training set" in the context of this device.

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

This information is not applicable and therefore not available in the document. There is no "training set" for this device.

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