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510(k) Data Aggregation

    K Number
    K021362
    Device Name
    LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
    Manufacturer
    ORGAN RECOVERY SYSTEMS, INC.
    Date Cleared
    2003-07-31

    (457 days)

    Product Code
    KDN
    Regulation Number
    876.5880
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)

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

    LifePort™, Kidney Perfusion Transporter (KTR) is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or a study that proves the device meets specific performance metrics. The document is a 510(k) clearance letter from the FDA for the 'LifePort™ Kidney Perfusion Transporter (KTR)', indicating that the device is substantially equivalent to legally marketed predicate devices.

    The letter and the 'Indications for Use Statement' do not contain details about:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets or data provenance.
    • Number and qualifications of experts for ground truth.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used (e.g., pathology, outcomes data).
    • Sample size for the training set.
    • How ground truth for the training set was established.

    Therefore, I cannot fulfill your request for this specific information using the provided text.

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