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510(k) Data Aggregation

    K Number
    K020135
    Manufacturer
    Date Cleared
    2002-04-12

    (87 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120

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

    General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of a RF (radio frequency) electrosurgical current through an accessory electrode for . cutting and coagulation at the operative site.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the Conmed System 2000 ESU, an electrosurgical generator. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. However, it does not include details on specific acceptance criteria, study designs, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for a device performance study.

    Therefore, I cannot extract:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes used, test set data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. Information on MRMC comparative effectiveness studies or effect sizes.
    6. Information on standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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