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510(k) Data Aggregation

    K Number
    K153078
    Device Name
    LED Curing Light GT-2000
    Manufacturer
    MONITEX INDUSTRIAL CO., LTD.
    Date Cleared
    2016-06-28

    (249 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This "LED Curing Light GT-2000" is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 360-420 nm and 420-490 nm by dental professionals.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the "LED Curing Light GT-2000." This type of document does not typically contain the detailed study information (acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics) that would be present in a clinical or performance study report.

    The letter primarily states that the device has been found substantially equivalent to a predicate device and can be legally marketed. It references the indications for use but does not detail the studies proving its performance against specific criteria.

    Therefore,Based on the provided FDA 510(k) clearance letter:

    1. A table of acceptance criteria and the reported device performance: This information is not available in the provided document. The 510(k) letter confirms substantial equivalence but does not detail specific performance studies, acceptance criteria, or reported device performance metrics like sensitivity, specificity, or AUC.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not available in the provided document.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not available in the provided document.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not available in the provided document.

    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 available in the provided document. The device is an "LED Curing Light," which is a dental tool, not an AI diagnostic device. Therefore, a MRMC study for AI assistance would not be applicable.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not available in the provided document. As mentioned, this is a hardware device for dental curing, not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not available in the provided document. For a curing light, the 'ground truth' related to its performance would likely involve objective measurements of light output, curing effectiveness on dental materials, and safety standards, rather than diagnostic ground truth typically established by experts or pathology.

    8. The sample size for the training set: This information is not available in the provided document.

    9. How the ground truth for the training set was established: This information is not available in the provided document.

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