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Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges

Dental Porcelain Zr Dental block is composed of ZrO2, YfO2, Y2O3, Al2O3 and other material (SiO2(≤0.16%), Fe2O3(≤0.05%), TiO2(≤0.04%), MnO2(≤0.002%), Na2Q(≤0.001%) and they are intended for use by dental technicians for dental prothesis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zr Dental block, but it's important to note a significant limitation:

The provided submission document (K093571) for the Zr Dental block is a 510(k) Premarket Notification. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a standalone study with detailed statistical analysis.

Therefore, many of the requested points below (especially those related to sample sizes, ground truth, expert consensus, and MRMC studies) are not typically included or required in a 510(k) summary for this type of device. The document emphasizes comparison of chemical and performance properties to a predicate device.

Here's the information extracted and interpreted based on the content available:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: For a 510(k), the "acceptance criteria" are largely an demonstration that the new device is "substantially equivalent" to an existing predicate device. The document does not specify quantitative thresholds or performance metrics that the Zr Dental block must meet in isolation. Instead, it asserts equivalence in categories like "chemical properties" and "performance properties" to the predicate. The direct numerical values for the constituent materials (e.g., SiO2 ≤ 0.16%) can be considered de-facto acceptance criteria for chemical composition, aligning with what would be acceptable for such a device.

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

• Sample Size: Not specified. The submission likely relies on internal testing to confirm chemical composition and physical properties, but a specific "test set" in the context of clinical studies or image analysis is not mentioned because this is a material device, not an AI or imaging device.
• Data Provenance: Not specified. Testing would typically be conducted by the manufacturer (Ams Co., Ltd.) in Korea. The submission is from Korea. The data would be prospective in the sense that the manufacturer tested their product.

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

• Not Applicable. This is a dental material, not a diagnostic or interpretative device that requires expert ground truth establishment in the traditional sense of medical image analysis or clinical outcomes. Material properties are verified through laboratory tests and analytical chemistry, not expert consensus.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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

• No. This is not an AI-assisted diagnostic device, so MRMC studies are not relevant.

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

• Not Applicable. This is a material itself, not an algorithm. Its performance is inherent to its physical and chemical properties when fabricated into a restoration.

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

• Laboratory Testing/Analytical Chemistry: For a dental block, "ground truth" would be established through standard laboratory methods (e.g., elemental analysis, mechanical strength testing, biocompatibility assays) to determine its chemical composition and physical characteristics, and then comparing these against established industry standards or the predicate device's known properties.

8. The sample size for the training set

• Not Applicable. This is a manufactured material, not a machine learning algorithm. It does not have a "training set" in that context. The material's formula and manufacturing processes are developed based on materials science principles and iterative refinement, not statistical training data.

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

• Not Applicable. See point 8.

Summary of the Study (as presented in a 510(k) summary):

The "study" for this 510(k) is primarily a comparative analysis demonstrating "substantial equivalence" of the Zr Dental block to a predicate device (K083201 Zmatch Block). The submission asserts that the new device is equivalent in:

• Intended Use: Both are for CAD/CAM fabrication of all ceramic dental restorations (inlays, onlays, veneers, crowns, and bridges).
• Technological Characteristics: This includes components, chemical properties, and performance properties. The document explicitly lists the chemical composition of the Zr Dental block.

The "proof" is the assertion by the submitter that based on the provided information (likely internal technical data and comparisons not fully detailed in the public summary), the device is safe, effective, and substantially equivalent to the predicate. The FDA's review of the 510(k) confirms this substantial equivalence. No specific standalone clinical trial or deeply detailed performance study is presented in this summary document to quantitatively define and meet distinct acceptance criteria beyond the qualitative comparison to the predicate.

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