(327 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, Al2Os and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
This document describes a 510(k) premarket notification for a dental device, specifically "Dental Glass Ceramics Blocks." It is not for a software-as-a-medical-device (SaMD) or an AI/ML-driven device. Thus, the questions about acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device (Dental Lithium Disilicate Glass Ceramic Block, K141727) through non-clinical bench testing and biocompatibility testing. The "acceptance criteria" in this context refer to the physical, chemical, and biocompatibility properties of the dental material, not the performance of an AI model.
Here's how to interpret the provided information in the context of the requested questions, noting the inapplicability of many of them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a direct "table of acceptance criteria and reported device performance" in the way one would expect for an AI/ML device (e.g., accuracy, sensitivity, specificity thresholds). Instead, it lists various characteristics and states whether the proposed device is "Same" or "Comparable" to the predicate, and whether it "Meet the requirements of ISO 6872:2015" for certain properties.
Here's a partial interpretation based on the "Substantial Equivalence Comparison" table and "Non-clinical Testing" section:
| Characteristic/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Product Code | Same as predicate (EIH) | EIH |
| Indications for Use | Same as predicate | Same as predicate |
| Materials | Comparable to predicate (acknowledging minor compositional differences but demonstrably equivalent physical/chemical properties) | SiO2, Li2O, K2O, Al2O3 and other oxides (Comparable to predicate) |
| Processing at Dental lab | Same as predicate (Hot Press or CAD/CAM) | Hot Press (Up. Press Series), CAD/CAM (Up.CAD Series) (Same as predicate) |
| Geometry | Similar to predicate (Blocks) | Blocks (Similar to predicate, which also includes disc and rod) |
| Dimension | Same as predicate (Various) | Various (Same as predicate) |
| Single use | Same as predicate (Yes) | Yes (Same as predicate) |
| Available color | Same as predicate (Various) | Various (Same as predicate) |
| Sterile | Same as predicate (Non-sterile) | Non-sterile (Same as predicate) |
| Density (g/cm³) | Meet the requirements of ISO 6872:2015 | Meet the requirements of ISO 6872:2015 |
| Cytotoxicity (ISO 10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect |
| Irritation Oral Mucosa Irritation (ISO 10993-10:2010) | Not a primary oral mucosa irritant | Not a primary oral mucosa irritant under the conditions of the study |
| Sensitization (ISO 10993-10:2010) | Not a sensitizer | Not a sensitizer under the conditions of the study |
| Subacute and Subchronic Toxicity (ISO 10993-11:2006) | No subacute and subchronic toxic effects observed | No subacute and subchronic toxic effects observed |
| Genotoxicity (ISO 10993-3:2003) | No genotoxic effects observed | No genotoxic effects observed |
| Flexural Strength, Coefficient of Thermal Expansion, Glass Transition Temperature | Not explicitly stated "acceptance criteria" but implied they meet relevant standards based on "Bench testing was performed per ISO 6872:2015 and internal procedures...All tests were verified to meet acceptance criteria." | Results not detailed, but stated to meet acceptance criteria per ISO 6872:2015. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the bench testing. The testing would involve a specific number of material samples, but the document does not quantify this.
- Data Provenance: Not applicable in terms of "country of origin of the data" or "retrospective/prospective" studies as this is bench testing of physical materials, not clinical data collection. The manufacturer is Aidite (Qinhuangdao) Technology Co., Ltd. in China.
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 material properties like density or tensile strength, is established by laboratory measurement and adherence to international standards (e.g., ISO 6872:2015), not by expert consensus in the way medical image interpretation would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication is a concept for human interpretation consistency or resolution of discrepancies, not for physical material property measurement.
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 is not an AI-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical/Chemical Properties based on International Standards: The "ground truth" for this device's performance is objective measurement of its physical and chemical properties (e.g., density, flexural strength, biocompatibility) as defined by and tested according to international standards (e.g., ISO 6872:2015, ISO 10993 series).
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device that requires a "training set."
§ 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.