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510(k) Data Aggregation

    K Number
    K060330
    Device Name
    SEE-IT CARIES DETECTOR
    Manufacturer
    RONVIG DENTAL MFG. A/S
    Date Cleared
    2006-04-07

    (57 days)

    Product Code
    LFC
    Regulation Number
    872.1740
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    RONVIG DENTAL MFG. A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A visual aid for the identification of infected carious dentine.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed study information needed to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the SEE-IT™ Caries Detector, stating that the device is substantially equivalent to a legally marketed predicate device.

    The letter mentions the device's regulation number, regulation name, regulatory class, and product code, but it does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Details about sample sizes, data provenance, ground truth establishment, or expert qualifications.
    3. Information on adjudication methods or multi-reader multi-case (MRMC) studies.
    4. Data regarding standalone algorithm performance.
    5. Training set details.

    Therefore, I cannot fulfill your request for these specific details based on the provided text.

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