(71 days)
Upcera Zirconia Blanks are intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Upcera Zirconia Blanks are derived from zirconia powder that has been processed into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
The provided text is a 510(k) summary for the Upcera Zirconia Blanks. This document is for a dental material, not an AI/ML powered device, therefore, the requested information points regarding AI/ML device performance and study details (such as sample size for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this submission.
The acceptance criteria and device performance for this type of device are primarily related to material properties and substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a dental material), "acceptance criteria" and "device performance" are typically demonstrated through:
- Substantial Equivalence: Showing the new device has the same intended use and technological characteristics as a legally marketed predicate device, or has different technological characteristics but is as safe and effective and does not raise new questions of safety or effectiveness.
- Material Properties: Mechanical, chemical, and biological properties of the material are assessed to ensure it meets established standards for dental materials. While specific values are not provided in this summary, the FDA's clearance implies these were provided in the full submission.
| Acceptance Criteria (Implied for Dental Materials) | Reported Device Performance (Implied from 510(k) Clearance) |
|---|---|
| Intended Use: Same as predicate device (Porcelain Powder for Clinical Use). | Met: "Upcera Zirconia Blanks are intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers." This matches the general intended use of the predicated device and other devices in the same classification. |
| Technological Characteristics: Similar to predicate (Zirconia Blanks, Type BYZ), or differences do not raise new safety/effectiveness questions. | Met: The summary states, "It has been shown in this 510(k) submission that the differences between the Upcera Zirconia Blanks and the predicate device do not raise any questions regarding its safety and effectiveness. Upcera Zirconia Blanks, as designed and manufactured, are as safe and effective as the predicate device and therefore is determined to be substantially equivalent to the referenced predicate device." This implies that the material composition, processing, and resulting properties are comparable to the predicate or have been demonstrated not to introduce new risks. Specific performance values for properties like flexural strength, biocompatibility, etc., would have been submitted to the FDA but are not detailed in this public summary. |
| Safety and Effectiveness: Demonstrate device is as safe and effective as the predicate device. | Met: The FDA has cleared the device, stating it is "substantially equivalent" to the predicate, which inherently confirms its safety and effectiveness for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to a 510(k) submission for a dental material like Zirconia Blanks, as it does not involve a "test set" in the context of an AI/ML algorithm or diagnostic study. The approval is based on material characterization and comparison to a predicate device.
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 this 510(k) submission. "Ground truth" in this context would relate to material standards and potentially biocompatibility testing, not expert interpretation of diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this 510(k) submission.
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 to this 510(k) submission. This is a material, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable to this 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a dental material, the "ground truth" for its properties is established through adherence to recognized international and national standards for material testing (e.g., ISO standards for dental ceramics, biocompatibility standards). The raw data would come from laboratory tests of mechanical properties, chemical composition, microstructure, and biocompatibility assays.
8. The sample size for the training set
This is not applicable to this 510(k) submission.
9. How the ground truth for the training set was established
This is not applicable to this 510(k) submission.
§ 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.