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Dental Ceramic Blocks are indicated for fabrication of inlays onlays, aminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.

Dental Ceramic Blocks consist of methacrylate, benzoyl peroxide, barium glass powder and pigmen to form a solid block of material. The unique marriage of the materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This non-sterile material is milled in a dental CAD/CAM machine into restorative form for single patient use. Dental Ceramic Blocks is provided as non-sterile.

The provided text is a 510(k) Premarket Notification for a dental device, "Dental Ceramic Blocks." This document does not include information about AI/ML device performance or a study demonstrating the device meets acceptance criteria related to AI/ML.

The device described is a physical material (dental ceramic blocks) used to fabricate dental restorations. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance testing of these physical blocks, not an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding AI/ML device performance, ground truth establishment, expert adjudication, or MRMC studies because the provided document does not pertain to an AI/ML device.

However, I can extract the information related to the physical device's performance acceptance criteria and proof if that is what you are looking for.

For the physical device (Dental Ceramic Blocks), here's what the document states regarding acceptance criteria and performance:

1. Table of acceptance criteria and reported device performance:

Note: The document explicitly states "Although the results have slightly difference, they meet the acceptance criteria. Therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate devices" for Flexural Strength and Radioactive properties.

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

• The document does not specify sample sizes for non-clinical performance and biocompatibility tests. It only lists the standards followed (e.g., ISO 4049, ISO 10993 series).
• Data provenance: Not explicitly stated, but implies lab testing. No information on country of origin of data. These are non-clinical / bench tests, not patient data trials.

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

• Not applicable. This is for a physical device, not an AI/ML diagnostic or measurement device. Ground truth is established by laboratory measurement standards (e.g., ISO standards).

4. Adjudication method for the test set:

• Not applicable. This is for a physical device, not an AI/ML diagnostic or measurement device.

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 document is not about an AI/ML device.

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

• Not applicable. This document is not about an AI/ML device.

7. The type of ground truth used:

• For the physical properties (Flexural Strength, Radiopacity), ground truth is established by standardized laboratory measurement methods outlined in ISO 4049 and ISO 7491.
• For Biocompatibility, ground truth is established by adherence to ISO 10993 series standards test methods (e.g., cytotoxicity, irritation, systemic toxicity, genotoxicity).

8. The sample size for the training set:

• Not applicable. This document is not about an AI/ML device, so there is no "training set."

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

• Not applicable. This document is not about an AI/ML device.

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Dental Ceramic is indicated for use for metal-ceramic full veneers and for zirconia full veneers and partial veneers.

Dental Ceramic divided into two categories: Metal Ceramic; Zirconia Ceramic. They are used to be made for simulation tooth of human whose ages above 18. After fired, form the whole or part of a dental restoration or prosthesis. It is made by Aluminium oxide(Al2O3), Silicon dioxide (SiO2), Potassium carbonate (K2CO3), Sodium carbonate (Na2CO3), Calcium oxide (CaO), Zirconium dioxide (ZrO2).

Metal Ceramic: a complete metallic substructure of Dental Ceramic are Glaze separated two parts-metal and ceramic, which is made of metal alloys and whose inner is a framework. The materials within the metallic is broadly divided into three categories: precious metal, semiprecious metal alloys and non-precious metal alloys, being usually called inner alloy crown.

Zirconia Ceramic: A complete Zirconia Ceramics are separated two parts-Zirconia coping and porcelain layer (Dentin layer and Enamel layer), as shown in the figure, the innermost layer of dental ceramic is Zirconia coping which is a framework. It has a positive impact on bearing and combining closely with the dentin layer.

The provided text describes a 510(k) summary for a dental ceramic device, which does not contain information about an AI/ML powered device. Therefore, a description of acceptance criteria and studies related to AI/ML performance is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through material composition, mechanical properties (flexural strength, solubility, glass transition temperature), and biocompatibility testing.

Here's the information extracted from the provided text, structured to align with the prompt's request where applicable for non-AI devices:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not explicitly stated for performance testing (mechanical properties) or biocompatibility. The results are presented as single values for each material property type (e.g., flexural strength).
• Data provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based material characterization studies conducted by the manufacturer or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is not an AI/ML product where expert consensus for ground truth is typically required. The ground truth for material properties is established by recognized international standards (ISO 6872 and ISO 10993).

4. Adjudication method for the test set: Not applicable. This device does not involve subjective assessment requiring adjudication.

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 ceramic material, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used:

• Mechanical Performance: Ground truth is established by the requirements and methodologies defined in ISO 6872:2008 (and comparison to ISO 6872:2015) for Dentistry - Ceramic materials.
• Biocompatibility: Ground truth is established by the requirements and methodologies defined in ISO 10993 series and USP40 for biological evaluation of medical devices.

8. The sample size for the training set: Not applicable. This device is a material, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Dental Ceramic is indicated for use with the:

• preparation of inlays .
• preparation of onlays .
• preparation of veneers .
• preparation of crowns .

The Dental Ceramic is indicated for use with CEREC devices marketed by Sirona, in Bensheim, Germany. The blooks are compatible with all CEREC devices up to The Dental Ocramio is manuted i are compatible with the CEREC model MC XL and Inlab model MC XL.

The present Dental Ceramic blocks are grindable leucite reinforced glass ceramic blocks for use with CEREC® and inLab® devices marketed by Sirona, Bensheim, Germany. The blocks are are compatible with all CEREC models up to CEREC 3 and inLab but are not compatible with the CEREC model MC XL and Inlab model MC XL.

This 510(k) summary for K080479, "Dental Ceramic," does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a premarket notification for a dental ceramic material, which is a Class II device. The submission is an "Abbreviated 510(k)" as described in FDA's guidance, meaning it primarily demonstrates substantial equivalence by providing chemical composition and certification of compliance with relevant consensus standards.

Therefore, I cannot provide the requested information in the format specified because the provided text does not describe any specific performance criteria, testing, or studies that would typically be associated with software or AI/ML-driven medical devices.

The key points from the provided text are:

• Device Type: Dental Ceramic blocks (material).
• Purpose: Used for inlays, onlays, veneers, and crowns with CEREC® and inLab® devices.
• Regulatory Pathway: Abbreviated 510(k), demonstrating substantial equivalence through chemical composition and compliance with consensus standards.
• No mention of AI/ML components: The device is a material, not a diagnostic or AI-powered system that would require performance studies against specific acceptance criteria.
• No mention of studies: The document states "Data provided in this submission to establish substantial equivalence includes chemical composition and certification of compliance with relevant consensus standards." This indicates a different type of evaluation than a clinical or performance study with a test set, ground truth, or expert readers.

If this were a submission for a device involving AI or software, the requested information would be crucial. However, for a dental ceramic, the regulatory requirements for demonstrating safety and effectiveness are met differently, typically through material properties testing and comparison to predicate devices, rather than clinical performance studies with specific statistical endpoints.

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