(475 days)
For the fabrication of metal free single and multiple unit crowns/bridges, inlays, onlays bonded dental restorations.
ICE Zirkon Transluzent Plus is a dental porcelain system composed of zirconia based blocks which utilizes CAD/CAM technology for dental restoration fabrication.
This document is a 510(k) submission for a dental material (ICE Zirkon Transluzent Plus), not an AI device. Therefore, the requested information regarding acceptance criteria and studies for an AI device cannot be extracted from this document. The document describes the equivalence of the new dental material to a predicate device based on material properties and established standards, not an AI algorithm's performance.
However, I can provide the information available about the dental material from the document, interpreted through the lens of device performance for that material:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Standard Reference) | Reported Device Performance (ICE Zirkon Transluzent Plus) |
|---|---|---|
| Flexural Strength | ISO 6872:2008 (Type II, Class 1a&b and 2a esthetic ceramic classification) | Not explicitly quantified in this summary, but stated to meet ISO 6872:2008 for its classification and to maintain mechanical strength. |
| Chemical Solubility | ISO 6872:2008 | Not explicitly quantified, but stated to be tested and substantially equivalent to predicate. |
| Radioactivity | ISO 6872:2008 | Not explicitly quantified, but stated to be tested and substantially equivalent to predicate. |
| Glass Transition Temperature (Tg) | Not explicitly stated (likely part of material characterization) | Not explicitly quantified, but stated to be tested and substantially equivalent to predicate. |
| Coefficient of Thermal Expansion (CTE) | Not explicitly stated (likely part of material characterization) | Not explicitly quantified, but stated to be tested and substantially equivalent to predicate. |
| Translucency | Improved over predicate device | Stated as an improvement over the predicate, while maintaining mechanical strength. |
| Biocompatibility | Substantially equivalent to predicate | Stated to be substantially equivalent to the predicate. |
2. Sample size used for the test set and the data provenance:
- This document describes testing of a physical dental material, not a software device or an AI model. Therefore, "test set" and "data provenance" as typically understood for AI models are not applicable.
- The testing performed would be on physical samples of the ceramic material. The document does not specify the number of samples used for each test (flexural strength, solubility, etc.).
- Data provenance: Not directly described, but the company is Zirkonzahn, GmbH, located in Gais, Italy. The testing would have been performed by or for the manufacturer. This is a prospective evaluation of a new material.
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 is not applicable to a physical dental material. "Ground truth" for this device refers to objective material properties measured against established international standards (like ISO 6872:2008), not expert consensus on interpretations of images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a physical material. Material properties are measured according to standardized protocols, not adjudicated by experts in the same way as clinical assessments or model outputs.
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 as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI device. The "device" itself is the ceramic material. Its performance is inherent in its physical and chemical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this dental material, the "ground truth" for its performance is based on measurements against established international standards and validated testing methodologies (e.g., ISO 6872:2008 for flexural strength, chemical solubility, radioactivity). It's an objective measurement of a material's properties.
8. The sample size for the training set:
- Not applicable as this is not an AI device. There is no "training set" for physical material properties.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI 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.