(67 days)
Zirox is a dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations by veneering zirconium oxide (ZrO2) frameworks. The coefficient of thermal expansion [CTE (25-500°C) of these zirconium oxide (ZrO₂) frameworks has to equal approximately 10x10*9K1
Zirox® is a dental porcelain system that consists of 127 different ceramic powders. lt is intended to be used by professional dental technicians to manufacture all-ceramic dental appliances for the sole use of particular patients. Zirox® is recommended for veneering zirconium oxide (ZrQ), frameworks, in which it provides an easy to use dental restorative material to fabricate dental restorations with the best possible aesthetic results. The coefficient of thermal expansion [CTE ۾5-500°C] of these zirconium oxide (ZrO₂) frameworks had to be approximately 10 x 10 6 K1. Zirox® meets all applicable requirements of the standard ISO 6872: 1995 "Dental ceramic".
This document describes a premarket notification (510(k)) for a dental porcelain system called Zirox. The 510(k) process is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than proving efficacy through clinical trials with acceptance criteria based on performance metrics. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are common for AI/ML device evaluations, is not present in this type of regulatory submission for a dental material.
Here's a breakdown of what can be extracted from the provided text and why other requested information is not available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the 510(k) summary. For a material like Zirox, "acceptance criteria" are usually based on meeting established national or international standards for dental materials (e.g., ISO standards), rather than performance metrics from a comparative clinical study. The device claims to meet ISO 6872:1995.
What is reported:
- Device meets relevant standard: "Zirox® meets all applicable requirements of the standard ISO 6872: 1995 "Dental ceramic"."
- Coefficient of Thermal Expansion (CTE) requirement: The zirconium oxide (ZrO₂) frameworks it veneers must have a CTE [25-500°C] of approximately 10 x 10⁻⁶ K⁻¹. (This is a requirement for the frameworks it interacts with, not an acceptance criterion for the device's own performance in a study).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a 510(k) premarket notification for a dental material, not a study involving a test set of data. The submission relies on demonstrating substantial equivalence to a predicate device and adherence to material standards, not the analysis of a specific data set in the context of AI/ML evaluation.
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. There is no test set or ground truth established by experts in the context of this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no test set or adjudication method 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 is a physical dental material, not an AI/ML device intended to assist human readers.
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. There is no "ground truth" in the context of an AI/ML algorithm evaluation. The closest concept is the adherence to material standards (ISO 6872:1995).
8. The sample size for the training set:
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set or ground truth in the context of an AI/ML algorithm evaluation.
Summary of Relevant Information from the 510(k) Notification for Zirox:
- Device Name: Zirox®
- Device Description: A dental porcelain system consisting of 127 different ceramic powders.
- Intended Use: To be used by professional dental technicians to manufacture all-ceramic dental appliances for individual patients, specifically for veneering zirconium oxide (ZrO₂) frameworks.
- Key Requirement/Performance Claim (for associated frameworks): The coefficient of thermal expansion [CTE 25-500°C] of the zirconium oxide (ZrO₂) frameworks to be veneered must be approximately 10 x 10⁻⁶ K⁻¹.
- Demonstration of Safety and Effectiveness: The device relies on demonstrating substantial equivalence to a legally marketed predicate device (Cerabien ZR Dental Porcelain System, K031968) and conformity to recognized standards.
- Conformance Standard: "Zirox® meets all applicable requirements of the standard ISO 6872: 1995 "Dental ceramic"."
Conclusion:
This 510(k) submission for Zirox is for a traditional dental material and therefore does not contain the types of acceptance criteria, study details, or ground truth methodologies that would be associated with an AI/ML device evaluation. The "study" in this context refers to the conformity assessment against an international standard (ISO 6872:1995) and the demonstration of substantial equivalence through material properties and intended use.
§ 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.