(58 days)
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. All blanks are processed through dental laboratories or by dental professionals.
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is derived from zirconia powder that has been processed through various molding and sintering techniques – 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 zirconia powder is composed of ZrO2 , Y2O3, HfO2 and other oxides. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
"Dental Zirconia Block (Model: HT-plus, ST, SHT, UT, 3D-Pro)" is supplied in different shapes, such as blocks, disc, and semi-disc, or customer ordered shapes. It is also supplied in the combinations of 21 different colors, and single and multi-layer aesthetic effect.
The different colors are originated from the different constituent of color additives (such as Fe>O3, Er>O3); and the multilayer aesthetic effect is originated from the different padding method used in the process of dry pressing.
The provided document is a 510(k) summary for a Dental Zirconia Block and does not describe an AI medical device or an MRMC comparative effectiveness study. Therefore, it does not contain the information required to answer most of the questions about acceptance criteria for an AI device.
The document discusses bench testing performed to ensure the "Dental Zirconia Block" met its specifications according to ISO 6872:2008 and internal procedures. It also mentions biocompatibility testing. The "acceptance criteria" discussed are for a physical material, not for the performance of an AI algorithm.
Here's what can be extracted from the document regarding the physical device, recognizing that this is NOT an AI device study:
1. A table of acceptance criteria and the reported device performance:
The document states: "All tests were verified to meet acceptance criteria." However, it does not provide a table listing the specific acceptance criteria values for each test, nor the reported numerical performance outcomes. It only lists the types of tests performed.
Tests Performed:
- Uniformity
- Freedom from Extraneous Materials
- Radioactivity
- Shrinkage factor
- Sintered Density before Sintering
- Sintered Density after Sintering
- Expansion Coefficient
- Sintered Flexural Strength
- Chemical Solubility
- Vickers hardness
Biocompatibility Endpoints Considered (per ISO 10993-1):
- Cytotoxicity (ISO 10993-5)
- Irritation & Sensitization (ISO 10993-10)
- Acute Systematic Toxicity (ISO 10993-11)
- Subacute Subchronic Systematic Toxicity (ISO 10993-11)
- Material Mediated Pyrogenicity (ISO 10993-11)
- Implantation (ISO 10993-6)
- Chronic Systematic Toxicity (ISO 10993-11)
- Genotoxicity (ISO 10993-3)
- Carcinogenicity (ISO 10993-3)
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes for any of the non-clinical tests mentioned. It also does not discuss "data provenance" in the context of clinical data, as this is a physical material testing rather than a clinical study.
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):
Not applicable. This is not a study involving expert review for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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. The document explicitly states: "Clinical Study is not performed for this device." (Section 5.10). An AI study or MRMC study was not conducted for this dental material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the physical properties, the "ground truth" would be established by validated test methods per ISO 6872:2008 and internal procedures. For biocompatibility, it was evaluated based on the principles and tests outlined in ISO 10993-1 and related parts.
8. The sample size for the training set:
Not applicable. There is no AI model or training set discussed.
9. How the ground truth for the training set was established:
Not applicable. There is no AI model or training set discussed.
In summary, the provided document details the 510(k) submission for a non-AI medical device (Dental Zirconia Block) and therefore does not contain the information requested regarding AI acceptance criteria or AI study designs.
§ 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.