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510(k) Data Aggregation

    K Number
    K190079
    Device Name
    ArgenZ HT+
    Manufacturer
    The Argen Corporation
    Date Cleared
    2019-04-12

    (86 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K071410,K180252
    Predicate For
    K201915,K250393
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructures restorations up to a full arch.

    Device Description

    ArgenZ HT+ is a pressed Yttria stabilized Zirconia with primary oxides of Hafnium and Aluminum with naturally occurring trace oxides used to produce various shades.

    AI/ML Overview
    1. Acceptance Criteria and Reported Device Performance
    Acceptance Criteria (from BS EN ISO 6872:2015 via predicate device or standard)Reported Device Performance (ArgenZ HT+)
    Flexural strength: ≥ 800 MPa1348 MPa (ArgenZ HT+ unshaded)
    1172 MPa (ArgenZ HT+ Shade A4)
    1143 MPa (ArgenZ HT+ Shade OM1)
    Chemical solubility: < 100 µg/cm²66.11 µg/cm² (ArgenZ HT+ unshaded)
    3.10 µg/cm² (ArgenZ HT+ Shade A4)
    3.10 µg/cm² (ArgenZ HT+ Shade OM1)
    Coefficient of Thermal Expansion: (Not explicitly stated as a pass/fail criterion, but a comparative value)10.3 µm/m-C° (25-500°C)
    Cytotoxicity: No evidence of cell lysis or toxicityMet the requirements of the test.

    1. Sample Size and Data Provenance

      • The document does not explicitly state the sample size used for the mechanical and chemical property tests. The results are presented as single values (e.g., "Test Result").
      • The data provenance is not specified in terms of country of origin or whether the studies were retrospective or prospective. It implies the performance testing was conducted by or for The Argen Corporation as part of their 510(k) submission.

    2. Number of Experts and Qualifications

      • This submission is for a dental material (zirconia), not an AI/software device that requires expert review for ground truth. Therefore, there were no experts establishing ground truth in the context of human interpretation of data. The ground truth for material properties is established by standardized laboratory testing methods.

    3. Adjudication Method

      • Not applicable for this type of device (dental material). Adjudication methods like 2+1 or 3+1 are typical for studies involving human interpretation or AI model output where consensus among experts is needed.

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

      • No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret images, and the AI assists in this interpretation. This submission is for a dental material with physical and chemical properties.

    5. Standalone (Algorithm Only) Performance

      • Not applicable. This is not an algorithm or AI device. The performance data relates to the physical and chemical properties of the zirconia material itself.

    6. Type of Ground Truth Used

      • The ground truth for the device's performance relies on objective laboratory measurements based on established international standards (BS EN ISO 6872:2015 for mechanical/chemical properties and ISO 10993-5 for biocompatibility/cytotoxicity). This is akin to "outcomes data" in a broader sense of directly measured physical properties and biological responses, rather than expert consensus on subjective interpretations.

    7. Sample Size for the Training Set

      • Not applicable. This is a material, not a machine learning model, so there is no concept of a "training set" in this context.

    8. How Ground Truth for the Training Set Was Established

      • Not applicable, as there is no training set for a material. The "ground truth" for the material's properties is established through the standardized testing methodologies detailed above.
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