(265 days)
Dental ceramic restorations made from ADAMANT ZIRCONIA DISC are indicated for crowns and multi-unit bridges (up to a maximum of three elements). Applications include both anterior and posterior regions.
The ADAMANT ZIRCONIA DISC is a ceramic block, composed of partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) (Y-TZP) that can be cut/milled for forming dental restorations such as crowns and bridges (up to a maximum of three elements). Applications include both anterior and posterior regions. The ADAMANT ZIRCONIA DISC is designed for milled production on commercial CAD/CAM systems. After milling the disc, it is final sintered, so the Zirconia Disc is transformed into the object as dental restorations.
The provided text describes a 510(k) premarket notification for the "ADAMANT ZIRCONIA DISC," a dental ceramic material. This means the filing is to demonstrate substantial equivalence to existing legally marketed devices, rather than a de novo approval requiring extensive clinical efficacy trials. Therefore, the information provided focuses on non-clinical performance data and comparison to predicate devices, not on detailed acceptance criteria for a diagnostic AI device or a comparative effectiveness study with human readers.
Based on the provided document, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a typical "acceptance criteria" table for a diagnostic AI device. Instead, it details performance criteria against international standards for dental ceramic materials and biocompatibility:
Acceptance Criteria (Standard Requirement) | Reported Device Performance (ADAMANT ZIRCONIA DISC) |
---|---|
Biocompatibility (ISO 10993) | |
Cytotoxicity test | Passed (No cytotoxic effect) |
Intracutaneous reactivity in rabbits | Passed (Met test requirements) |
Skin Sensitization Study in the Guinea Pig (Maximization Method) | Passed (No skin sensitization produced) |
Genotoxicity: Bacterial Reverse Mutation Study | Passed (Test article extracts nonmutagenic) |
Material Performance (ISO 6872:2008, Dentistry Ceramic materials) | |
Uniformity of the material | Passed |
Freedom from extraneous materials | Passed |
Physical and chemical properties: Activity concentration of uranium 238 | Passed |
Physical and chemical properties: Thermal expansion coefficient | Passed |
Physical and chemical properties: Flexural Strength | Passed (515 MPa – 1349 MPa) |
Physical and chemical properties: Chemical solubility | Passed |
Density (after sintering) | 6.04 ~ 6.33 g/cm³ (Acceptance criteria implied by predicate comparison as ≥ 6.0 g/cm³) |
Chemical Composition (e.g., ZrO2 + HfO2 + Y2O3 [wt%]) | ≥ 99.0 (Acceptance criteria implied by predicate comparison) |
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 does not specify sample sizes for individual tests. It refers to "non-clinical testing" and lists various tests, but without quantifying the number of samples or specimens used for each. There is no information regarding data provenance (country of origin, retrospective/prospective), as these are material property tests rather than clinical data.
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):
This section is not applicable to this device. The ADAMANT ZIRCONIA DISC is a material for dental restorations, not a diagnostic device requiring expert interpretation or ground truth establishment based on clinical judgment. The "ground truth" for its performance is determined by adherence to scientific and engineering standards (ISO 10993, ISO 6872) through physical and chemical laboratory tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. The tests performed are laboratory-based material characterizations, not assessments requiring expert adjudication of clinical findings.
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 is not applicable. The device is a dental ceramic material, not an AI-powered diagnostic system. No human reader studies, with or without AI assistance, were performed or are relevant to its approval.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance of the ADAMANT ZIRCONIA DISC is based on established international standards for dentistry ceramic materials (ISO 6872) and biological evaluation of medical devices (ISO 10993). These standards define the acceptable physical, chemical, and biological properties a material must possess. The "ground truth" is therefore derived from the specifications and testing methodologies outlined in these widely recognized standards.
8. The sample size for the training set:
This is not applicable. The ADAMANT ZIRCONIA DISC is a material, not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established:
This is not applicable. As there is no training set for a material, there is no ground truth established for it in this context.
§ 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.