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The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

ZIROX is a pre-formed machineable dental blank composed of zirconium oxide. ZIROX is available in partially-sintered. ZIROX is available in different shapes, and dimensions, ZIROX has two types that are 51x23x16 and 51x23x18. The only difference between 51x23x16 and 51x23x18 is the size(height).

ZIROX is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations. ZIROX is designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks. The blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques for design.

This 510(k) premarket notification for ZIROX, a porcelain powder for clinical use, does not contain information about acceptance criteria or a study proving that a device meets those criteria in the way typically associated with AI/ML-enabled medical devices. The document is for a dental material (zirconium oxide blank) and focuses on substantial equivalence to predicate devices based on material composition, intended use, and biomechanical properties, rather than performance metrics.

Therefore, most of the requested information regarding acceptance criteria, device performance, study design, expert consensus, and ground truth is not applicable to this submission.

Here's an explanation based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This 510(k) submission for a dental material (zirconium oxide blank) does not define specific performance acceptance criteria for an AI/ML component. The submission focuses on demonstrating substantial equivalence to predicate devices based on material characteristics and intended use.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. There is no test set in the context of an algorithmic performance evaluation. The submission refers to a pre-formed machineable dental blank; any "testing" would relate to its physical and chemical properties and biocompatibility, not an AI/ML algorithm's performance on a data set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no "ground truth" establishment in the context of evaluating an AI/ML algorithm's output. The device itself is the material, not an diagnostic or interpretative algorithm.

4. Adjudication Method

Not applicable. No adjudication method is mentioned as there is no diagnostic or interpretive task being evaluated by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study is relevant for evaluating the impact of an AI/ML algorithm on human reader performance. This submission is for a dental material, not an AI/ML device, so no such study was conducted or is applicable.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a material, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant.

7. Type of Ground Truth Used

Not applicable. No ground truth is established for an algorithmic output.

8. Sample Size for the Training Set

Not applicable. There is no training set for an AI/ML algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

Summary of the Study (as described in the 510(k) document - focusing on substantial equivalence):

The submission demonstrates substantial equivalence of ZIROX to legally marketed predicate devices rather than proving performance against specific acceptance criteria for an AI/ML component. The "study" (or rather, the basis for clearance) relies on the following:

• Comparison to Predicate Devices: ZIROX is compared to Dentsply-Cercon Base (K013230), 3M-LAVA Zirconia (K011394), and Sagemax Bioceramics-Sagemax Z-Blank (K062695).
• Identical Intended Use and Material: The document states that ZIROX and the predicate devices are "identical in intended use and material."
• Similar Biocompatibility and Biomechanical Strength/Properties: The submission asserts that ZIROX and predicate devices are "biocompatible and have similar biomechanical strength and properties."

This approach to clearance for a device like ZIROX, a dental material, is typical for 510(k) submissions where the device is not an AI/ML software but a physical product.

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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.

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