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    K Number
    K123268
    Device Name
    SMARTSTITCH PERFECTPASSER SYSTEM
    Manufacturer
    ARTHOCARE CORPORATION
    Date Cleared
    2012-11-07

    (19 days)

    Product Code
    GAT,NBH
    Regulation Number
    878.5000
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SMARTSTITCH PERFECTPASSER SYSTEM

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

    The SmartStitch® PerfectPasser® System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.

    Device Description

    The SmartStitch PerfectPasser System is a Class II device consisting of the following components: SmartStitch® PerfectPasser® Connector, SmartStitch® Handle, Suture Cartridge containing Suture.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for testing, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, types of ground truth, or details about training sets. The document is primarily a regulatory submission letter for a medical device (SmartStitch® PerfectPasser® System) and includes general information about the device and its intended use. Therefore, I cannot fulfill your request for that specific information based on the input provided.

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