(56 days)
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.
§ 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.