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The Ceramic Denture Zirconia Ceramics Block are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.

The Ceramic Denture Zirconia Ceramics Block are derived from zirconia powder that has been processed via uni-aixial die pressing, followed by isostatic pressing, to achieve various shapes of uniform density and distribution. The ceramic blocks can be fabricated into various prosthetic dental devices. The zirconia powder is composed of ZrO2+Y2O3+HfO2+Al2O3. The performance of the Ceramic Denture Zirconia Ceramics Block conforms to ISO 6872:2015 Dentistry: Ceramic Materials.

The Ceramic Denture Zirconia Ceramics Block are offered in four (4) different product families of shapes and a multitude of different sizes and are capable of being machined into complex dental shapes using modern machining methods.

The provided document is a 510(k) premarket notification for a medical device, specifically Ceramic Denture Zirconia Ceramics Block. This type of submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device rather than proving clinical efficacy through extensive studies that align with acceptance criteria typically seen in AI/ML device submissions.

Therefore, the information requested about acceptance criteria and study details (like sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, and training set details) is not applicable to this type of regulatory submission for this device.

Instead, the document details the device's physical and chemical properties and verifies its compliance with recognized international standards (ISO).

Here's the relevant information that can be extracted, formatted as requested where possible, but with the understanding that the "acceptance criteria" here refers to meeting established standards and physical properties:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission does not involve a "test set" in the context of an AI/ML device evaluating data. The testing performed focuses on the physical, chemical, and biological properties of the material itself, typically using a sufficient number of samples as prescribed by the relevant ISO standards to ensure statistical validity for material characterization. The document does not specify exact sample sizes for each physical test but asserts compliance with the standards, which inherently include sampling requirements.
• Data Provenance: The tests were conducted internally by the manufacturer, Qinhuangdao Silide Ceramic Technology Co., Ltd., to demonstrate compliance with ISO standards.

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

• Not Applicable. Ground truth, in the context of expert consensus, is not relevant for this material science submission. Compliance with ISO standards for material properties (e.g., density, strength, biocompatibility) is determined by laboratory testing measurements against predefined standard thresholds, not by expert interpretation or consensus.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for reconciling differences in expert interpretations, which is not part of this material testing.

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. No MRMC study was performed as this is not an AI-assisted diagnostic or therapeutic device.

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

• Not Applicable. This is a material (zirconia block) for dental restorations, not a standalone algorithm.

7. The type of ground truth used

• Objective Measurement against Standards: The "ground truth" for this device's performance is established by objective laboratory measurements of physical, mechanical, and chemical properties (e.g., density, bending strength, chemical solubility, composition) compared against the quantitative requirements and thresholds specified in international standards such as ISO 6872:2015 and ISO 10993 series.
• Biocompatibility "ground truth" is established through testing following ISO 10993 guidelines, demonstrating that the material does not induce adverse biological responses.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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