(65 days)
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded) are derived from Zirconia powder that has been processed into their final net shapes. These blanks are then further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + A12O2. The performance of the dental blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials. The shading effects of New Century All-Ceramic Dental Zirconia Blocks (Pre-Shaded) are achieved by blending different zirconia powder material, all from the same supplier; have almost identical composition, differing only in the trace amount of inorganic pigments to achieve the shading effects in dental blanks. The performance of the preshaded dental zirconia blanks also conforms to ISO 6872, Dentistry: Ceramic Materials.
The provided text describes a 510(k) premarket notification for "New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)". This is a submission for a medical device used in dentistry, specifically for CAD/CAM technology to produce dental restorations. It is not a submission for an AI/ML device.
Therefore, most of the questions regarding acceptance criteria, study design for AI devices, sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device (K140070 Luxer Shaded Zirconia) based on non-clinical performance testing and technological comparison.
However, I can extract the information that is present in the document which relates to performance and criteria.
1. A table of acceptance criteria and the reported device performance:
The document states that bench testing was performed per ISO 6872:2008 and using internal testing procedures (for presintered and sintered density) to ensure that the device met specifications. It explicitly mentions:
"All tests were verified to meet acceptance criteria."
The specific acceptance criteria from ISO 6872:2008 are not detailed in the provided text, but the document confirms compliance. The device also underwent a biocompatibility assessment in accordance with ISO 10993-1.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 6872:2008 (Dentistry: Ceramic Materials) requirements for physical and mechanical properties | Met specifications; all tests verified to meet acceptance criteria. |
| Internal testing procedures for presintered and sintered density | Met specifications; all tests verified to meet acceptance criteria. |
| ISO 10993-1 (Biocompatibility assessment) | A biocompatibility assessment was conducted in accordance with ISO 10993-1. |
2. Sample sized 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 the non-clinical bench tests. The tests were performed "per ISO 6872:2008 and using internal testing procedures." The provenance of the data is implied to be from the manufacturer, Shanghai New Century Dental Materials Co., Ltd. in China, as they performed the tests.
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 as it is not an AI/ML device requiring clinical expert ground truth for interpretation. The "ground truth" here refers to the measured physical and mechanical properties of the material against established standards (ISO 6872:2008).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a non-AI/ML device.
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 for a non-AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for a non-AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is objective measurement against established international standards for ceramic dental materials (ISO 6872:2008) and internal specifications for density.
8. The sample size for the training set
Not applicable for a non-AI/ML device.
9. How the ground truth for the training set was established
Not applicable for a non-AI/ML 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.