(109 days)
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.
| Acceptance Criteria (Property based on ISO 6872:2015) | Reported Device Performance (Compliance) |
|---|---|
| Radioactivity (Bq.g-1) | Meet the requirements of ISO6872:2015 |
| Density (g/cm3) | Meet the requirements of ISO6872:2015 |
| Flexural Strength (MPa) | Meet the requirements of ISO6872:2015 |
| Coefficient of Thermal Expansion (K-1) | Meet the requirements of ISO6872:2015 |
| Glass Transition Temperature (°C) | Meet the requirements of ISO6872:2015 |
| Cytotoxicity (ISO10993-5:2009) | No cytotoxicity effect |
| Irritation Oral Mucosa Irritation (ISO10993-10:2010) | Not a primary oral mucosa irritant under the conditions of the study |
| Sensitization (ISO10993-10:2021) | Not a sensitizer under the conditions of the study |
| Subacute and Subchronic Toxicity (ISO10993-11:2006) | No subacute and subchronic toxic effects observed |
| Genotoxicity (ISO10993-3:2003) | No genotoxic effects observed |
| Dimension | Verified to meet acceptance criteria (implied by overall statement of compliance) |
| Chemical Solubility | Verified to meet acceptance criteria (implied by overall statement of compliance) |
| Linear Thermal Expansion Coefficient | Verified to meet acceptance criteria (implied by overall statement of compliance) |
| Freedom from Extraneous Materials | Verified to meet acceptance criteria (implied by overall statement of compliance) |
| Uniformity | Verified to meet acceptance criteria (implied by overall statement of compliance) |
| Sintering Density | Verified to meet acceptance criteria (implied by overall statement of compliance) |
| Fracture Toughness | Verified to meet acceptance criteria (implied by overall statement of compliance) |
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.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.