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510(k) Data Aggregation
(66 days)
ArgenZ MTZ zirconia can be used for the production of full-contour and substructure restorations up to and including a full arch.
All blanks are processed by dental laboratories or by dental professionals.
The ArgenZ MTZ (referring to multi-translucent, multi-layer) zirconia consist of yttria-stabilized pre-shaded 4 mole and 5 mole percent zirconia.
They are manufactured (pressed and sintered) into disc forms and offered multiple thicknesses and multiple shades. They contain oxides of Hafnium and Aluminum and minute amounts of coloring oxides of iron, erbium, cobalt and manganese.
The discs are single use, non-sterile devices and used for fabricating dental restorations, using CAD/CAM systems that can accommodate the disc sizes.
The provided document is a 510(k) Premarket Notification for a dental device, ArgenZ MTZ, which is a dental zirconia ceramic. It outlines the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.
This document describes the device itself and its physical and chemical properties, but does not describe a study involving a human expert in the loop (e.g., radiologist) or an AI algorithm for diagnostic purposes. Therefore, many of the requested items related to AI/human performance studies are not applicable to the information contained in this document.
However, I can extract information related to the acceptance criteria for the device's physical and chemical properties and how those properties were tested.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document provides a "Substantial Equivalence Comparison Table" that lists various physical and chemical properties and the device's performance against specified criteria, which effectively serve as acceptance criteria to demonstrate equivalence to the predicate device and compliance with ISO standards.
| Acceptance Criteria (Property) | Acceptance Standard / Predicate Performance | Reported Device Performance (ArgenZ MTZ) |
|---|---|---|
| Classification (per ISO 6872:2015) | Class 5 (Predicate) | Class 5 |
| Composition | Yttria-stabilized zirconia (5Y on top of 4Y - Predicate) | Based on yttria-stabilized zirconia, 5Y zirconia on top of 4Y zirconia |
| Color | Color (Predicate) | Color |
| Intended User | Professional dental technicians (Predicate) | Professional dental technicians |
| Single Use | Yes (Predicate) | Yes |
| Sterile | Non-sterile (Predicate) | Non-sterile |
| Physical Properties | Conform to ISO 6872:2015 (Predicate) | Conform to ISO 6872:2015 |
| Uniformity | Uniform (Predicate) | Uniform |
| Freedom from extraneous materials | Free from extraneous materials (Predicate) | Free from extraneous materials |
| Radioactivity | ≤ 1.0 Bq·g⁻¹ (Predicate) | ≤ 1.0 Bq·g⁻¹ |
| Flexural strength | ≥ 800 MPa (Predicate: Multilayer-3Dpro) | ≥ 800 MPa |
| Chemical solubility | < 100 µg/cm² (Predicate) | < 100 µg/cm² |
| Linear thermal expansion coefficient | (10.4±0.5)×10⁻⁶ K⁻¹ (Predicate: Multilayer-3D pro) | (9.9)×10⁻⁶ K⁻¹ |
| Biocompatibility | Conforms to ISO 7405:2018 (Predicate) | Conforms to ISO 10993-1 |
| Labeling | Complies with 21 CFR 801 (Predicate) | Complies with 21 CFR 801 |
2. Sample size used for the test set and the data provenance
The document states, "Bench testing, performed according to ISO 6872:2015 Dentistry – Ceramic materials, showed the ArgenZ MTZ meets the requirements specified in the standard."
While it specifies the standard used for testing, it does not provide the specific sample size (e.g., number of discs or samples tested for each property) nor the data provenance (e.g., country of origin, retrospective/prospective). The testing would have been conducted on a representative sample of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a material, and the "ground truth" for its performance is established through standardized physical and chemical bench testing, not expert interpretation of outputs like in AI/imaging studies.
4. Adjudication method for the test set
Not applicable. This is not a study involving human readers or AI algorithms requiring adjudication.
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 document pertains to a dental material, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No algorithm is being evaluated.
7. The type of ground truth used
The ground truth for the device's performance is established by objective measurements and adherence to recognized international standards for dental ceramic materials, specifically ISO 6872:2015 (for ceramic materials) and ISO 10993-1 (for biocompatibility). This is akin to "bench test results" against specified industry standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured dental material.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/machine learning device.
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