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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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(122 days)
ArgenZ Liquids are intended to be used by trained dental technicians as an accessory for shading ArgenZ allzirconia, monolithic restorations for anterior and posterior dental prosthetics.
ArqenZ Zirconia Coloring Liguids are dilute aqueous solutions of transition and lanthanoid metal salts used in combination with ArgenZ Zirconia material (K071410 and K150919) to properly shade teeth. Elements, which may include (but are not limited to) Co, Cr, Er, Fe, Mn, Pr, Ni, Bi, and Nd are combined with water to result in the finished product.
The provided text describes Argen Corporation's ArgenZ Liquids, which are dental coloring liquids for zirconia restorations. The document is a 510(k) premarket notification for the device, seeking substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Product Standard BS EN ISO 6872:2015) | Criteria | Reported Performance (ArgenZ Liquids) |
|---|---|---|
| Flexural Strength | ||
| ArgenZ HT+ | >= 800 MPa | 1230 MPa |
| ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4) | >= 800 MPa | 1223 MPa |
| ArgenZ Anterior | >= 500 MPa | 868 MPa |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3) | >= 500 MPa | 765 MPa |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4) | >= 500 MPa | 963 MPa |
| Chemical Solubility | ||
| ArgenZ HT+ | < 100 ug/cm² | 4.16 ug/cm² |
| ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4) | < 100 ug/cm² | 4.16 ug/cm² |
| ArgenZ Anterior | < 100 ug/cm² | 20.80 ug/cm² |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (A3) | < 100 ug/cm² | 10.32 ug/cm² |
| ArgenZ Anterior Shaded with ArgenZ ST Liquid (C4) | < 100 ug/cm² | 8.30 ug/cm² |
| Cytotoxicity (ISO 10993-5) | Reactivity grade <= 2 (mild reactivity) | All test articles showed no evidence of cell lysis or toxicity (i.e. grade <= 2). |
2. Sample Size for Test Set and Data Provenance
- Mechanical & Chemical Properties: The document does not specify the exact sample size for each test (flexural strength and chemical solubility). It mentions "test records of parent materials and representative accessories infused into the parent materials," and lists several variations (e.g., ArgenZ HT+, ArgenZ HT+ Shaded with ArgenZ HT Liquid (A4)). The provenance is not explicitly stated, but these are laboratory tests conducted by the manufacturer.
- Cytotoxicity: The document states that "test articles for the cytotoxicity testing were selected as representative samples for each product family, and determined to be worst case scenarios for potential biocompatibility issues." Four specific liquid/zirconia combinations were selected as representative samples (ST on K150919 (A3), ST on K150919 (C4), HT on K071410 (A4), HT on K071410 (B4)). The provenance is not explicitly stated, but these are laboratory tests conducted by the manufacturer.
3. Number of Experts and Qualifications
This document describes a pre-market notification for a dental material, not a diagnostic device involving human interpretation. Therefore, there are no "experts" in the context of establishing ground truth for diagnostic accuracy, nor qualifications for such experts. The evaluation relies on standardized material testing.
4. Adjudication Method
Not applicable, as this is related to material properties testing, not human interpretation of diagnostic results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a dental coloring liquid used by trained dental technicians, not a diagnostic tool where human readers assess cases. The study focuses on material properties, not reader performance.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a material, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation is based on product standards (BS EN ISO 6872:2015 for mechanical and chemical properties, and ISO 10993-5 for cytotoxicity). These standards define the acceptable limits for various material properties.
8. Sample Size for Training Set
Not applicable. This is a material, not a machine learning model, so there is no training set in the conventional sense. The "training" in manufacturing refers to established processes and quality control.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no training set for an AI/algorithm. For materials, the "ground truth" for manufacturing involves adherence to established specifications, quality control procedures, and compliance with relevant industry standards and regulations.
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