(441 days)
"Zibone Zirconia Blocks" are intended for CAD/CAM fabrication of full ceramic dental restorations such as copings, crowns, inlays, onlays, veneers, and bridges of 3 or less units.
"Zibone Zirconia Blocks" are made from partially sintered zirconium oxide. The devices are to be CNC machined to construct dental restorations and substructures such as crowns and bridges with the aid of CAD/CAM technology.
The devices are in cylinder forms with a constant diameter of 98mm and variety of heights from 12 to 20 mm, and in rectangular bar forms with various lengths and widths with the height of 16mm.
This document is a 510(k) Premarket Notification from the FDA to Coho Technology Co., Ltd. regarding their "Zibone Zirconia Blocks." The core of the document confirms that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices.
The document does not describe a study involving an AI/software device or a diagnostic device, or a study that evaluates human reader performance. Instead, it pertains to a dental material (zirconia blocks) and focuses on demonstrating its physical, chemical, and mechanical equivalence to a predicate device, along with biocompatibility.
Therefore, most of the requested information about acceptance criteria, study design for AI/human reader performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not applicable or cannot be extracted from this document.
However, I can extract the relevant information regarding the device's conformity to standards and the tests performed to establish its equivalence.
Here's the relevant information based on the provided text:
Acceptance Criteria and Device Performance (for a Dental Material, not an AI Device):
The acceptance criteria here are based on meeting the specifications of an international standard for dental ceramics and demonstrating biocompatibility.
| Acceptance Criteria (based on ISO and Biocompatibility Standards) | Reported Device Performance (Summary from Document) |
|---|---|
| Conformance to ISO 6872:2008 (Dentistry - Ceramic materials) | "The material conforms to international standard ISO 6872:2008 Dentistry - Ceramic materials to guarantee biocompatibility and necessary mechanical strength." "tests per ISO 6872 validated the equivalence of these two devices and ensured that the subject device is suitable for its indications." Tested for: Thermal expansion, chemical solubility, 4-point bending strength, and radiation tests per ISO 6872. |
| Biocompatibility | Biocompatibility evaluations performed: |
- Cytotoxicity per ISO 10993-5 and ISO 10993-11
- Sensitization and irritation per ISO 10993-10
- Pyrogen tests per ISO 10993-11 and USP 151
Results: "favorable biocompatibility results" |
| Substantial Equivalence to Predicate Device (K100145) | "Based on similar chemical composition, intended use, technological characteristics, physical properties testing, and favorable biocompatibility results, Zibone Zirconia Blocks are substantially equivalent to the predicate device." Key similarities highlighted: Same major chemical component (ZrO2), similar indications for use, similar method of fabrication (CAD/CAM Systems), similar types of restorations, and same device forming process (Press CIP). Differences in percentages of chemical composition were noted but deemed equivalent based on ISO 6872 testing. |
Information NOT Applicable to this Document (as it's not an AI/Software/Diagnostic Device Study):
- Sample sizes used for the test set and the data provenance: Not applicable. This document refers to bench testing of physical materials, not a digital dataset or patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a material's physical properties is established through standardized laboratory testing, not expert consensus on images.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is relevant for diagnostic studies, not material testing.
- 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 is for AI-assisted diagnostic device studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is the established specifications and performance parameters outlined by ISO 6872:2008 and other biocompatibility standards (e.g., ISO 10993 series, USP 151), validated through laboratory bench testing.
- The sample size for the training set: Not applicable. This is for machine learning models.
- How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory approval for a dental material based on its physical, chemical, and mechanical properties and biocompatibility, not a performance study for an AI-powered diagnostic tool.
§ 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.