(28 days)
CDC Zirconia Blanks are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (copings, frameworks, inlays, onlays, crowns and bridges) as prescribed by a dentist.
This product is for professional use only. Not for use by the general public or OTC.
CDC Zirconia blanks are pressed and sintered blocks of Yttria stabilized Zirconia for use in CAD/CAM milling machines. After the Zirconia block is milled, it is sintered into a high strength all ceramic material suitable for copings, inlays, crowns, and bridges.
The provided text describes a 510(k) summary for "CDC Zirconia Blanks," which are yttria-stabilized zirconia blocks for CAD/CAM milling of dental restorations. The submission seeks to demonstrate substantial equivalence to a predicate device (KO93560, Upcera Zirconia Blanks), rather than proving specific performance criteria through a detailed study.
Therefore, many of the requested elements pertaining to AI or software-based medical devices (like acceptance criteria for performance metrics, study design with human readers, ground truth establishment, training sets, etc.) are not applicable to this submission, as it is for a physical dental material and relies on the established safety and effectiveness of similar existing devices.
Here's an assessment based on the available information:
1. A table of acceptance criteria and the reported device performance
This 510(k) submission for CDC Zirconia Blanks does not define specific performance acceptance criteria in terms of diagnostic accuracy, sensitivity, specificity, or other metrics typically seen for AI/software devices. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device.
The reported "performance" is primarily a statement of safety and effectiveness based on similarity to previously cleared devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Substantial Equivalence to Predicate Device (KO93560, Upcera Zirconia Blanks) based on: | "The successful prior use of the components of CDC Zirconia Blanks product in legally marketed devices, the similarity of the formulations used in this device and earlier devices, and the substantially equivalence of CDC Zirconia Blanks to prior cleared devices support the safety and effectiveness of the CDC Zirconia blank product for the intended use." |
| Does not raise new questions regarding safety and effectiveness. | "It has been shown in this 510(k) submission that the difference between CDC Zirconia Blanks and the predicate device do not raise any questions regarding its safety and effectiveness." |
| Meeting the stated Intended Use | "CDC Zirconia Blanks are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (copings, frameworks, inlays, onlays, crowns and bridges) as prescribed by a dentist." |
2. Sample size used for the test set and the data provenance
Not applicable. This submission focuses on the material's composition and manufacturing, not a diagnostic or AI-driven performance study needing a test set of data samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is described.
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 device is a physical dental material, not an AI or software product for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth in the context of a diagnostic performance study is not relevant here. The "truth" for this submission is that the material's properties and intended use are substantially equivalent to a legally marketed predicate.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set for an algorithm.
§ 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.