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510(k) Data Aggregation

    K Number
    K050580
    Date Cleared
    2005-04-20

    (44 days)

    Product Code
    Regulation Number
    888.1100
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Smith & Nephew InteliJET™ Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

    The Smith & Nephew InteliJET™ Fluid Management System-HERMES Ready is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

    Device Description

    The Smith & Nephew InteliJETTM Fluid Management Systems are microprocessor-controlled delivery of irrigation fluid during intra-articular surgery. This controlled delivery is accomplished via an electronic pressure control loop between the control unit and the tube cassette.

    AI/ML Overview

    The provided text is a 510(k) summary for the Smith & Nephew InteliJET™ Fluid Management Systems. It describes the device, its intended use, and its comparison to predicate devices, but it does not contain any information about acceptance criteria, device performance, or details of a study that proves the device meets specific criteria.

    The document states: "All verification and validation data demonstrate that the devices are safe and effective and performs as intended." However, it does not provide any specifics on what these data are, what the acceptance criteria were, or the results of any such studies.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as none of this information is present in the provided text.

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