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510(k) Data Aggregation
(98 days)
ArgenZ Esthetic Plus
ArgenZ Esthetic Plus blanks are intended to be used in the fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems.
ArgenZ Esthetic Plus is a pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder.
The provided text describes a 510(k) premarket notification for a dental ceramic device, ArgenZ Esthetic Plus, and its claim of substantial equivalence to a predicate device, BruxZir Anterior (K143330). The information does not describe a study involving an AI device and human readers, but rather a comparison of physical and biological properties of two ceramic materials.
Therefore, the following points address the questions based on the provided document, acknowledging that most questions related to AI studies are not applicable.
1. Table of acceptance criteria and the reported device performance
| Criteria Category | Acceptance Criteria (Predicate) | Reported Device Performance (ArgenZ Esthetic Plus) |
|---|---|---|
| Classification of Ceramic | Type II, Class 6 (per ISO 6872) | Type II, Class 5 (The document states "ArgenZ Esthetic Plus satisfies requirements for Class 5 (type II) ceramics when tested according to ISO 6872:2008" and then in the comparison table, "Same" next to the predicate's "Type II, Class 6". This appears to be a slight inconsistency in the document's reporting between the general description and the comparison table. For the purpose of this table, I'll use what is explicitly stated for the proposed device's performance, which is Class 5 (and then "Same" for the "Type II"). The comparison table also later confirms "Same" for Classification of Ceramic.) |
| Material | Tosoh Powder (Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder) | Same (Tosoh Powder; Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder) |
| Flexural Strength | Meets requirements, per ISO 6872 (>600 MPa Mean Value) | >600 MPa Mean Value |
| Coefficient of Thermal Expansion (CTE) / (25-500 °C) | 11 X 10-6/K | Same (11 X 10-6/K) |
| Density | 6.05 g/cm3 | Same (6.05 g/cm3) |
| Biocompatibility | Biocompatible | Same (Biocompatible, as material is identical) |
| Intended Use | Fabrication of custom-made all ceramic restorations for anterior and posterior location. | Fabrication of inlays, crowns, copings, and fixed bridges (up to 3 units) using various CAD/CAM systems. (The document states the proposed device has "comparable technical characteristics and Indications for Use to the predicate device" and that "both have the same intended use.") |
| Product Composition | Pressed Yttria stabilized Zirconia with oxides of Hafnium and Aluminum and an organic binder. | Identical composition |
| Physical Properties | Satisfy requirements for a Class 6 (Type II) ceramic when tested in accordance with ISO 6872:2008. | Satisfy requirements for a Class 5 (Type II) ceramic when tested in accordance with ISO 6872:2008. (The document states "The materials are identical to the predicate device and hence have the same physical properties." and that it "satisfies requirements for a Class 5 (type II) ceramic when tested in accordance with ISO 6872:2008.") |
| Safety and Effectiveness | Deemed safe and effective by predicate clearance. | Substantially equivalent in safety and effectiveness to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes material testing for dental ceramics, not a clinical study involving a test set of data. The testing was conducted on samples of the ArgenZ Esthetic Plus material to ensure it meets ISO standards and is comparable to the predicate device. Details on the number of samples or the country of origin for these material tests are not provided. The tests would be prospective in the sense that they are performed on the manufactured material to evaluate its properties.
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)
This question is not applicable to the provided document. The ground truth for this device relates to the physical and biological properties of the ceramic material, which are established through standardized laboratory testing (e.g., ISO 6872:2008) rather than expert consensus on a test set of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies or expert reviews of data, which is not the nature of the information presented here.
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
This question is not applicable. The document describes a medical device in the dental ceramic category, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The document describes a medical device in the dental ceramic category, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The ground truth for the ArgenZ Esthetic Plus device and its predicate is based on standardized laboratory testing and material specifications as defined by ISO 6872:2008 for dental ceramics, as well as the known properties of the base material (Yttrium-stabilized Zirconia) in medical applications. This includes measurements of flexural strength, density, coefficient of thermal expansion, and confirmation of biocompatibility.
8. The sample size for the training set
This question is not applicable. As the document concerns a physical material, there is no "training set" in the context of an AI model. The material's properties are inherent to its composition and manufacturing process.
9. How the ground truth for the training set was established
This question is not applicable. There is no training set for an AI model. The "ground truth" for the material's properties is established through adherence to international standards for dental ceramics (ISO 6872:2008) and well-documented scientific principles of material science and biocompatibility.
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