(60 days)
Dental Zirconia Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Dental Zirconia Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872. Dentistry - Ceramic materials.
Dental Zirconia Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
The retrieved document is a 510(k) summary for a dental device (Dental Zirconia Blank). It is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study designed to prove the device meets specific performance acceptance criteria for an AI/software product. Therefore, much of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document.
However, the document does contain information about non-clinical testing and general acceptance of these tests based on existing standards.
Here's a breakdown of the relevant information from the document:
1. Table of acceptance criteria and the reported device performance:
The document states that "Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Zirconia Blank met its specifications. All tests were verified to meet acceptance criteria." While specific numerical acceptance criteria are not tabulated, the document explicitly states that the tests passed these criteria. The relevant tests and their reported performance are:
| Acceptance Criteria (Implied by adherence to standards) | Reported Device Performance |
|---|---|
| Radioactivity (per ISO 6872:2015) | Met acceptance criteria |
| Flexural Strength (per ISO 6872:2015) | Met acceptance criteria |
| Chemical Solubility (per ISO 6872:2015) | Met acceptance criteria |
| Linear Thermal Expansion Coefficient (per ISO 6872:2015) | Met acceptance criteria |
| Freedom from Extraneous Materials (per ISO 6872:2015) | Met acceptance criteria |
| Uniformity (per ISO 6872:2015) | Met acceptance criteria |
| Shrinkage Factor (per ISO 6872:2015) | Met acceptance criteria |
| Pre-sintered Density (per ISO 6872:2015) | Met acceptance criteria |
| Sintered Density (per ISO 6872:2015) | Met acceptance criteria |
| Fracture Toughness (per ISO 6872:2015) | Met acceptance criteria |
| Biocompatibility Testing (per ISO 10993-1:2018 and ISO 7405:2018): | |
| Cytotoxicity (ISO 10993-5:2009) | Pass (non cytotoxic) |
| Oral Mucosa Irritation (ISO 10993-23:2021) | Pass (no potential irritation) |
| Skin Sensitization (ISO 10993-10:2021) | Pass (no sensitization) |
| Subacute Toxicity (ISO 10993-11:2017) | Pass (did not induce subacute systemic toxicity) |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Pass (no acute system toxicity) |
| In Vitro Mammalian Cell Gene Mutation (ISO 10993-3:2014) | Pass (non-mutagenic) |
| In vitro Mammalian Chromosome Aberration (ISO 10993-3:2014) | Pass (did not induce structural chromosome aberrations) |
| Bacterial Reverse Mutation (ISO 10993-3:2014) | Pass (no potential mutagenesis) |
| Muscle Implant (ISO 10993-6:2016) | Pass (did not induce local effects) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical bench testing and in vitro and in vivo biocompatibility tests, not a "test set" in the context of an AI/software solution. Therefore, information about a test set sample size or data provenance in that sense is not provided. The biocompatibility tests, however, would have involved animal models (Syrian hamsters, guinea pigs, rats, ICR mice, rabbits), which would constitute the "test set" for those specific biological evaluations. The document does not specify the number of animals used for each test. The testing was conducted by or on behalf of HUNAN CERAMASTER MATERIAL TECHNOLOGY CO.,LTD, located in China. The "provenance" of the data is therefore China. The nature of these tests is prospective for the specific evaluations conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a material science and biocompatibility assessment for a dental zirconia blank, not an AI/software device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is typically used for human-reviewed data in AI/software evaluations.
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 pertains to a physical dental material, 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 not an algorithm or software device. Bench testing and biocompatibility studies evaluate the material's properties directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is established by recognized international standards (ISO 6872:2015 for material properties, ISO 10993 series and ISO 7405:2018 for biocompatibility). The acceptance criteria outlined in these standards serve as the "ground truth" to determine if the device meets its specifications. For biocompatibility tests, the outcomes observed in the biological test systems (e.g., cell viability, tissue response, animal health) against the defined parameters of the ISO standards constitute the "ground truth."
8. The sample size for the training set
Not applicable. There is no AI algorithm or "training set" involved in the testing described for this dental material.
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, this question is not relevant.
§ 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.