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510(k) Data Aggregation

    K Number
    K973542
    Device Name
    MASKY
    Manufacturer
    PRESSING DI MONTICELLI RAG. STEFANO
    Date Cleared
    1998-02-10

    (145 days)

    Product Code
    EBI,DAT
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K954115
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Masky is indicated for use when patients require a partial denture prosthetic that has a substantial amount of exposed metal in the frame. Masky covers exposed metal areas to reduce visual impact of framework in the mouth. Can also cover wires used in orthodontic appliances to make appliances less visible.

    Device Description

    Resin material that is biologically inert once cured on the metallic framework, similar to ArtGlass, with exception of curing methodology. ArtGlass cures by light; Masky by heat.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance (Masky)
    Biocompatibility: Absence of chromosomal aberrations induced in vitro.Masky demonstrated no negative results in this test, indicating no chromosomal aberrations.
    Biocompatibility: No adverse effect on cell viability using propidium iodide uptake.Masky demonstrated no negative results in this test, meaning no adverse effect on cell viability.
    Biocompatibility: Non-mutagenic in the Ames Salmonella/microsome test.Masky demonstrated no negative results in this test, indicating it is non-mutagenic.
    Biocompatibility: Absence of sister chromatid exchange in vitro.Masky demonstrated no negative results in this test, indicating no sister chromatid exchange.
    Similar in design, composition, and function to predicate device (ArtGlass).Masky is a resin material that is biologically inert once cured, similar to ArtGlass, with the exception of curing methodology (ArtGlass cures by light, Masky by heat).
    Intended Use: Cover exposed portions of metallic frameworks in partial denture prostheses for natural appearance.Masky is indicated for this use and the biocompatibility tests support its safe application.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not explicitly stated. The document refers to "tests as performed by the Istituti Ortopedici Rizzoli for Pressing Italy" but does not specify the number of samples or specimens used for each test.
    • Data Provenance: The tests were performed in December 1996 by the Istituti Ortopedici Rizzoli for Pressing Italy. This indicates the data is retrospective (performed prior to the 510(k) submission) and originated from Italy.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

    This information is not provided in the document. The tests performed are laboratory-based biocompatibility assays, not studies requiring expert interpretation of clinical data in the same way, for example, a diagnostic imaging study would. The ground truth for these tests would be established by the scientific methodologies and controls inherent in each assay.

    4. Adjudication Method for the Test Set

    This information is not applicable/not provided in the document. The biocompatibility tests are objective laboratory assays with predetermined endpoints, rather than subjective assessments that would require an adjudication method.

    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

    No, an MRMC comparative effectiveness study was not conducted. This device is a material (tooth shade resin), not an AI-powered diagnostic or assistive tool for human readers.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

    This question is not applicable. "Masky" is a material, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here.

    7. The type of ground truth used

    The ground truth used for "Masky" is based on the results of standardized laboratory biocompatibility tests. These included:

    • Evaluation of chromosomal aberrations (in vitro)
    • Evaluation of cell viability (using propidium iodide uptake)
    • Mutagenicity in Ames Salmonella/microsome test
    • Evaluation of sister chromatid exchange (in vitro)

    8. The Sample Size for the Training Set

    This information is not applicable/not provided. "Masky" is a material, not a machine learning algorithm that requires a "training set."

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable. As stated above, "Masky" is a material, not an AI/ML algorithm requiring a training set. The "ground truth" related to its performance is established through the objective laboratory tests mentioned in point 7.

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