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510(k) Data Aggregation

    K Number
    K083306
    Device Name
    MODIFICATION TO ARTHROCARE ARTHROWANDS
    Manufacturer
    ARTHROCARE CORP.
    Date Cleared
    2008-12-10

    (30 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K082980
    Why did this record match?
    Reference Devices :

    K082980

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

    The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

    Device Description

    The ArthroCare ArthroWands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (ArthroCare ArthroWands). It is not a study about an AI/ML device. Therefore, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria, device performance, study types (MRMC, standalone), sample sizes, ground truth establishment, or expert qualifications in the context of an AI/ML study.

    The document primarily states that the proposed modifications to the ArthroCare ArthroWands are "not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices." It asserts substantial equivalence to a predicate device (K082980) based on unchanged indications for use, technology, principles of operation, and sterilization parameters, with only material specification changes.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance from an AI/ML study, nor any of the other requested details related to such a study, because the provided text does not describe an AI/ML product or performance study.

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