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510(k) Data Aggregation

    K Number
    K082408
    Device Name
    LEDEX, MODEL: WL-070
    Manufacturer
    DENTMATE TECHNOLOGY CO., LTD.
    Date Cleared
    2008-12-03

    (104 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K050408
    Predicate For
    K153514
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This LEDEX WL-070 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental curing light, the Ledex WL-070. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain the detailed information necessary to complete the requested table and answer the specific questions about acceptance criteria and a study design.

    Here's why and what information is missing:

    • Substantial Equivalence (SE) vs. Performance Studies: The FDA's 510(k) clearance process for most devices (especially Class II) primarily relies on demonstrating "substantial equivalence" to a predicate device. This often involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. While performance data are usually submitted, the FDA letter itself generally does not detail the specific acceptance criteria, study methodologies, or the results in the comprehensive way you've requested for an AI/CADe type of device.
    • Device Type: The Ledex WL-070 is an "Ultraviolet Activator For Polymerization" (a dental curing light). This is a hardware device, not an AI/CADe (Computer-Aided Detection/Diagnosis) software. The questions you've posed (e.g., MRMC studies, human readers with/without AI assistance, training/test sets, ground truth establishment for AI) are highly specific to AI/CADe systems, which are designed to assist human interpretation or to perform standalone diagnostic tasks with learned algorithms. A dental curing light hardens dental materials, and its performance is typically evaluated by criteria like light intensity, wavelength, curing depth, and temperature, not by AI-specific metrics.

    Therefore, I cannot populate the table or answer the questions with the provided document. The document confirms market clearance but does not delve into the specific study details for acceptance criteria and performance as would be relevant for an AI/CADe device.

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