(77 days)
Zirconia Blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
Zirconia Blanks are dental materials (semi finished products) made of presintered zirconium dioxide for milled production of crowns and bridges frameworks on commercial CAD/CAM systems or hand operated copymilling machines, with outstanding biocompatibility and high resistance against tension and pressure. In its pre-sintered condition the product is excellently suitable for preparing dental prostheses(crowns, bridges, superstructures, inlays and olays) produced by manual and machine milling technique.
This document does not describe an AI/ML device, nor does it describe a study to prove acceptance criteria that would include the information requested (such as sample size for test/training sets, expert qualifications, adjudication methods, or MRMC studies).
The document is a 510(k) summary for a dental device called "Zircostar (zirconia blanks)". It details the device's intended use, comparison to a predicate device, and non-clinical testing performed.
Here's the information that can be extracted from the provided text, related to the initial request for acceptance criteria and device performance, but framed within the context of non-clinical testing for a traditional medical device, not an AI/ML-driven one:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ISO 6872:2008 (Specific parameters not detailed) | Passed all tests |
| Material Analysis | (Not detailed) | Passed all tests |
| Biocompatibility | (Not detailed) | Passed all tests |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: Testing was performed by "third-party laboratories." The document doesn't specify countries of origin for the data or if it was retrospective/prospective, as these terms are not applicable to the non-clinical material and mechanical tests described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For this type of traditional medical device, "ground truth" as typically defined for AI/ML models (e.g., expert consensus on images) is not relevant. The "ground truth" here is adherence to established engineering and material science standards (e.g., ISO 6872:2008) in laboratory conditions.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in clinical or image-based studies. For non-clinical material testing, the "adjudication" is inherent in whether the measured mechanical and material properties meet the specified values in the relevant ISO standard.
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:
- No. An MRMC study was not conducted as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML device, so a standalone algorithm performance study is not applicable.
7. The type of ground truth used:
- Engineering and Material Science Standards: The "ground truth" was based on adherence to voluntary design standards, specifically ISO 6872:2008 for non-clinical testing, and general material analysis and biocompatibility standards. These standards define acceptable performance thresholds for dental materials.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
Summary Conclusion from the Document:
The device, Zircostar (zirconia blanks), was deemed substantially equivalent to its predicate device (Dental Direct DD Bio Z, DD Bio Z-transpa) based on:
- Identical intended use.
- Similar technological characteristics.
- Successful completion of non-clinical mechanical testing, material analysis, and biocompatibility tests against company specified design requirements and the voluntary design standard ISO 6872:2008.
- No clinical testing was performed or relied upon to determine substantial equivalence.
§ 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.