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BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

BruxZir® Esthetic NOW is a chairside zirconia material offering enhanced esthetic performance. These pre-shaded, fully sintered zirconia CAD/CAM blocks are used by dentists in the construction of custom-made dental restorations that require no sintering, staining, glazing or polishing.

The provided text describes the regulatory submission for a dental material (BruxZir® Esthetic NOW) and its comparison to a predicate device. It includes performance data, but NOT information typically associated with AI/ML device studies, such as sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, the response will focus on the available information regarding acceptance criteria and the study that proves the device meets those criteria, highlighting the lack of AI/ML-specific details where applicable.

Here's a summary of the acceptance criteria and study findings based on the provided document:

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document specifies "worst-case shades" for Flexural Strength, Chemical Solubility, CTE, and Radioactivity testing, and "all shades offered" for Shade Evaluation. However, the exact numerical sample sizes for these tests (e.g., number of blocks tested per shade) are not provided.

The data provenance is from non-clinical testing conducted by the manufacturer, Prismatik Dentalcraft, Inc. No information regarding country of origin of data or whether it was retrospective/prospective is specified, as these are material property tests rather than clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For "Shade evaluation," the document states "qualified evaluators." However, the number of experts and their specific qualifications are not provided. For other non-clinical tests (Flexural Strength, Solubility, CTE, Radioactivity, Biocompatibility, Packaging Validation), ground truth is established by standardized testing methods (e.g., ISO, ASTM) and material science principles, not typically by expert consensus.

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

Not applicable. This information is relevant for studies involving human interpretation or subjective assessment with consensus mechanisms, typically in clinical trials or image assessment studies. The described tests are objective material property measurements.

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 device is a dental material (zirconia milling block), not an AI/ML-based diagnostic or assistive device that would involve human readers or AI assistance.

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

Not applicable. As this is not an AI/ML device, this type of study is irrelevant.

7. The type of ground truth used

The ground truth for the performance criteria is established by:

• Standardized measurement thresholds: Specific values defined by international standards (ISO 6872:2024, ISO 10993-1:2018, ASTM D4169-22) for material properties (Flexural Strength, Chemical Solubility, CTE, Radioactivity) and biocompatibility.
• Visual comparison: For shade evaluation, it relied on comparison against VITA Classical shade guides and reference Bleach shade guides by qualified evaluators.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set mentioned or implied.

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

Not applicable. There is no training set for this device.

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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® Esthetic blanks are zirconia milling blanks used for the production of highly esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Esthetic restorations make them viable for use in all regions of the mouth. The manufactured dental restorations are made utilizing a CAD/CAM system for design and manufacture. The designed and manufactured dental restorations are then sintered at a high temperature. BruxZir® Esthetic blanks are available in white, bleach, and pre-shaded varieties that can be easily adjusted to match the final shade.

The provided text describes the submission for a dental device, BruxZir® Esthetic (K240882), and compares it to a predicate device (K213425). The focus of the submission is to demonstrate substantial equivalence through non-clinical testing. This is not a submission for an AI/ML powered device, and therefore, many of the requested elements related to AI/ML specific studies (e.g., MRMC studies, standalone AI performance, training set details, ground truth establishment for AI models) are not applicable.

However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets those criteria, specifically concerning the physical and chemical properties of the dental material.

Here's a breakdown of the requested information based on the provided text, while noting the inapplicability of AI/ML specific questions:

Device: BruxZir® Esthetic (K240882)
Device Type: Zirconia milling blanks for dental restorations. This is a material, not an AI/ML powered device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each non-clinical test. It states that "the test samples were made using the standard manufacturing process and QC process for BruxZir® Esthetic."

• Data Provenance: The tests were conducted by Prismatik Dentalcraft, Inc. directly, as part of their design verification "according to BruxZir® Esthetic Design Verification Protocol." This indicates the data is prospective, generated specifically for validating the device's properties based on established industry standards (ISO). The country of origin is not explicitly stated for the testing location, but the applicant (Prismatik Dentalcraft, Inc.) is based in Irvine, California, USA.

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

This question is not applicable as the studies conducted are non-clinical, laboratory-based physical and chemical property tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests is the quantitative measurement against an established ISO standard.

4. Adjudication Method for the Test Set

Not applicable. The tests are quantitative measurements against predefined ISO standards. There is no human subjective adjudication process for these material property tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI-powered device, nor is it a diagnostic imaging device that would typically involve human readers. The submission focuses on the material properties of dental zirconia.

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

No. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests is established by industry-standardized test methods (e.g., ISO 6872:2015/Amd 1:2018, ISO 10993-1:2018). The "ground truth" is adherence to the specified quantitative values and qualitative interpretations (e.g., biocompatible).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this type of device.

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