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    K Number
    K133042
    Device Name
    ENDOCEM ZR
    Manufacturer
    MARUCHI
    Date Cleared
    2014-05-12

    (227 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENDOCEM ZR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • A root-end filling material
    • For the repair of root canals as an apical plug during apexification
    • For repair of root perforations during root canal therapy
    • As a consequence of internal resorption
    • As a pulp capping material
    • For the filling of pulpotomy of deciduous tooth
    Device Description

    The raw materials of the ENDOCEM Zr are Natural Pure Cement and Zirconium dioxide, and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and is used in a putty form which gradually hardens in the oral environment.

    AI/ML Overview

    The acceptance criteria for the ENDOCEM Zr device and the study that proves it meets these criteria are described below.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Property Tested)Standard ReferencedPreset Test CriteriaReported Device Performance
    Visual AppearanceISO 6876Not explicitly detailed"All the test results met the preset test criteria."
    PackagingISO 6876Not explicitly detailed"All the test results met the preset test criteria."
    Setting TimeISO 6876Not explicitly detailed"All the test results met the preset test criteria."
    SolubilityISO 6876Not explicitly detailed"All the test results met the preset test criteria."
    RadiopacityISO 6876Not explicitly detailed"All the test results met the preset test criteria. Subject device has higher Radiopacity still maintaining biocompatibility."
    CytotoxicityISO 7405Not explicitly detailed for device"All the test results met the preset test criteria."
    Maximization test for delayed hypersensitivityISO 10993-10Not explicitly detailed"All the test results met the preset test criteria."
    Acute Systemic ToxicityISO 10993-11Not explicitly detailed"All the test results met the preset test criteria."
    Capacity (Other bench testing)Not specifiedNot explicitly detailed"All the test results met the preset test criteria."

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

    The provided document does not specify the sample sizes used for the non-clinical performance tests. The data provenance is also not explicitly stated beyond the tests being conducted based on ISO standards. Since these are bench tests on materials, it's implied to be laboratory-generated data, not human patient data, and therefore does not have a country of origin in the typical sense for clinical trials.

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

    This information is not applicable to the data provided. The performance data presented are for non-clinical bench tests (e.g., physical and biocompatibility properties) of a dental material, not for an AI/CADe device or a study involving expert interpretation of patient data. Therefore, there is no "ground truth" established by human experts in the context of image interpretation or diagnosis.

    4. Adjudication Method for the Test Set

    This information is not applicable as the study involved non-clinical bench testing of material properties, not a clinical study requiring adjudication of interpretations.

    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 information is not applicable. The submission describes the premarket notification for a dental material (ENDOCEM Zr), not an AI-assisted device. Therefore, no MRMC study or AI assistance effect size is discussed.

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

    This information is not applicable as the submission is for a dental material, not an algorithm or AI device.

    7. The Type of Ground Truth Used

    The "ground truth" for the non-clinical performance data is based on the objective measurements and assessments defined by the referenced ISO standards (e.g., ISO 6876 for physical properties, ISO 7405 for cytotoxicity). The criteria for "passing" or "meeting" the standard are inherent to the standard methods themselves.

    8. The Sample Size for the Training Set

    This information is not applicable. The device is a dental material, not a machine learning model, so there is no training set in the context of AI.

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

    This information is not applicable as there is no training set for a machine learning model.

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