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510(k) Data Aggregation

    K Number
    K042382
    Date Cleared
    2004-11-30

    (90 days)

    Product Code
    Regulation Number
    878.4580
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-GENERAL TECHNOLOGIES LLC

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

    no a lami i [ fuinsi no in icadores ties during examinations or minimal invasive surgical procedures

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Dual LED Lite Engine with Illumination LED Cable Coupled to a LED Lite Head), which signifies that the device is substantially equivalent to a predicate device. This type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, or ground truth establishment.

    The letter focuses on regulatory clearance, not the technical and clinical performance data that would typically be found in a study report or a summary of safety and effectiveness.

    Therefore, I cannot extract the following information from the provided text:

    1. A table of acceptance criteria and the reported device performance
    2. Sample sized used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    4. Adjudication method for the test set
    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
    6. If a standalone performance study was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established
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