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Dental Glass Ceramics Blocks are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/ CAM system.

Dental Glass Ceramics Blocks are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, K2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface. It has three model: HT,LT,ST, and totally 23 colors(A1,A2,A3,A3.5,A4,B1,B2,B3,B4,C1,C2, C3,C4,D2,D3,D4,BL1,BL2,BL3,BL4, OM1, OM2 and OM3).

This FDA 510(k) summary is for a dental device (Dental Glass Ceramics Blocks) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with acceptance criteria and performance metrics for a novel AI/software device. Therefore, much of the requested information regarding AI/software performance studies (like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.

However, I can extract the relevant information regarding acceptance criteria and device performance based on the provided text for this specific type of medical device.

Device Name: Dental Glass Ceramics Blocks (HT,LT,ST)

Acceptance Criteria and Reported Device Performance:

Study to Prove Device Meets Acceptance Criteria:

A non-clinical test and biocompatibility testing were conducted.

• Physical and mechanical properties of the subject device were evaluated according to ISO 6872:2015/AMD 1:2018. This standard classifies the device into:
  • Type II: All other forms of ceramic products.
  • Class 4: Monolithic ceramic for prostheses involving partially or fully covered substructure.
  • The document states that the new model "ST" and the existing models (HT, LT, which correspond to the predicate device's models) were tested and found to have physical/mechanical properties that met the requirements of ISO 6872.
• Biocompatibility testing was performed to verify the equivalent safety of the materials used. The results comply with ISO 10993-1:2018 and FDA Guidance.

Information Not Applicable to this Submission (as it is not an AI/software device):

• Sample size used for the test set and data provenance: Not applicable. This is a physical material device, not a software/AI system. The testing involved material properties, not a "test set" of data in the AI sense.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by standardized physical and chemical testing, not expert consensus on medical images or patient data.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic or predictive device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For material properties, the "ground truth" is defined by the objective measurements obtained through standardized physical, mechanical, and chemical tests to meet the specified ISO standard. For biocompatibility, it's defined by compliance with ISO 10993-1 and FDA guidance through specific biological evaluation tests.
• The sample size for the training set: Not applicable (no AI/machine learning involved).
• How the ground truth for the training set was established: Not applicable.

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Dental Glass Ceramics Blocks are indicating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.

Dental Glass Ceramics Blocks are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, K2O, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.

The provided document (K232438, a 510(k) premarket notification) describes the acceptance criteria and the study proving that "Dental Glass Ceramics Blocks" meet these criteria. However, it's crucial to understand that this document is about a material, not a medical imaging or AI-driven diagnostic device. Therefore, the questions related to AI assistance, human-in-the-loop performance, expert readers, and ground truth establishment in the context of diagnostic algorithms are not applicable to this submission.

The "device" in this context is a material used to fabricate dental restorations, and the acceptance criteria relate to its physical, chemical, and biocompatibility properties, primarily benchmarked against the ISO 6872 standard and a predicate device.

Here's the information extracted from the document based on the provided questions, with clarifications where the questions are not applicable:

1. Table of acceptance criteria and the reported device performance

The document states that the performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials, and that "All tests were verified to meet acceptance criteria." It then lists various properties and their compliance with ISO 6872:2015 requirements. The specific numerical values for the reported performance are not provided in this summary, but rather a statement of compliance with the standard is given.

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

The document does not specify a distinct "test set" sample size in terms of numbers of units tested. It states that "Bench testing was performed per ISO 6872:2015 and internal procedures." ISO standards typically define the minimum number of samples required for specific tests (e.g., number of specimens for flexural strength). The provenance of the data is not explicitly stated in terms of country of origin, but the manufacturer is based in China. The testing described is non-clinical bench testing, not retrospective or prospective data collection from human subjects.

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

This question is not applicable as this is not a diagnostic device or an AI algorithm requiring expert consensus for ground truth. The "ground truth" for this device is established through physical, chemical, and biological laboratory testing against international standards (ISO 6872 and ISO 10993 series).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in medical imaging studies involving multiple human readers, which is not relevant to the testing of dental ceramic blocks.

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 question is not applicable. This is not an AI-assisted diagnostic device.

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

This question is not applicable. This is not an algorithm.

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

The "ground truth" for this device is established by compliance with international standards for dental ceramics (ISO 6872:2015) and biocompatibility (ISO 10993 series, specifically ISO 10993-1:2018 for evaluation and subsequent specific parts for various tests like cytotoxicity, irritation, sensitization, toxicity, and genotoxicity). This is based on bench testing and laboratory analyses of the material's properties.

8. The sample size for the training set

This question is not applicable. As this is not an AI/ML device, there is no "training set."

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

This question is not applicable. There is no training set for this type of device.

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