LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K120243
    Device Name
    GAM-200
    Manufacturer
    GC AMERICA INC.
    Date Cleared
    2012-06-27

    (152 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K073283,K073209
    Why did this record match?
    Reference Devices :

    K073283, K073209

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges.
    2. Cementation of metal, ceramic, fiber posts, and cast post and cores.
    Device Description

    GAM-200 is a dual-cured self-adhesive resin cement. The mixed cement is hardened through the polymerization activated by redox or photo initiator system. The adhesiveness to tooth structure develops with phosphoric ester monomers which form ionic bonds with calcium ions. The acidic monomers also can polymerize with frame-forming monomers. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip and directly applied to restorations or the prepared cavity.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental cement device, GAM-200. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through clinical studies that would involve acceptance criteria and performance metrics in the way a medical AI/CAD device would.

    Therefore, the information requested in your prompt (e.g., acceptance criteria, sample size for test/training set, number of experts, adjudication methods, MRMC study, standalone performance, ground truth types) is not applicable to this type of device and submission.

    The document discusses the technical characteristics and equivalence of the GAM-200 dental cement to predicate devices based on material properties and in vitro tests, not on clinical performance in diagnosing or assisting with interpretation in a human-in-the-loop setting.

    However, I can extract the relevant information that is present in the document related to how the device's characteristics were assessed against established standards and predicate devices:

    1. Table of Acceptance Criteria and Reported Device Performance:

    CharacteristicAcceptance Criteria (compared to)Reported Device Performance (GAM-200)
    Curing MechanismSame as predicate devices (polymerization of uncured methacrylate ester monomers, redox or photo initiator system).Same as predicate devices (polymerization activated by redox or photo initiator system).
    Adhesive MechanismSame as predicate devices (acidic ester monomer developing adhesiveness to tooth structures by forming ionic bonds with calcium ions).Same as predicate devices (phosphoric ester monomers forming ionic bonds with calcium ions; acidic monomers polymerize with frame-forming monomers).
    Setting TimeWithin the same range as comparative (predicate) devices.In the same range as comparative devices.
    Depth of CureEquivalent to comparative (predicate) devices.Equivalent to comparative devices.
    Flexural StrengthValues indicating stability of materials in oral environment, equivalent to predicate devices.Equivalent values to predicate devices.
    Water SorptionValues indicating stability of materials in oral environment, equivalent to predicate devices.Equivalent values to predicate devices.
    SolubilityValues indicating stability of materials in oral environment, equivalent to predicate devices.Equivalent values to predicate devices.
    Biological Evaluation (Cytotoxicity)Equivalent to predicate devices (tested in accordance with MTT Assay method).Equivalent to predicate devices.
    ISO 4049: 2009Compliance with all requirements for Dentistry Polymer-based restorative materials.Complies with all requirements.
    ISO 11405: 2003 (Bond Strengths)Equivalent bond strengths to predicate devices (in accordance with the standard).Equivalent bond strengths to predicate devices.

    2. Sample size used for the test set and the data provenance: Not applicable. The evaluations are primarily in vitro material science tests against standards and predicate devices, not clinical trials with human subjects.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized testing procedures.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

    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 is a dental cement, not an AI/CAD system for image interpretation.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is based on established international standards (ISO 4049: 2009, ISO 11405: 2003) and laboratory test results for material properties and biological evaluation (cytotoxicity via MTT Assay). The comparison is against the performance of legally marketed predicate devices.

    8. The sample size for the training set: Not applicable. There is no machine learning "training set" for this device.

    9. How the ground truth for the training set was established: Not applicable.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1