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510(k) Data Aggregation

    K Number
    K142125
    Device Name
    New Medax Biopsy Systems
    Manufacturer
    MEDAX SRL UNIPERSONALE
    Date Cleared
    2015-12-22

    (505 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K172344
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BIOFEATHER: biopsy system must be used for histological biopsy on soft tissue.

    AVANGARDE: biopsy system must to be used for histological biopsy on soft tissues.

    COX: the Co-Axial introducer needle mod. COX must be used when multiple biopsies of soft tissue are required.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the New Medax Biopsy Systems. It states that the device is "substantially equivalent" to legally marketed predicate devices. This type of document does not contain the acceptance criteria or details of a study proving the device meets specific performance criteria.

    The FDA 510(k) process is primarily focused on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials to establish new performance metrics. Therefore, the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is typically not found within a 510(k) clearance letter.

    To fully answer your questions, one would generally need to refer to a separate clinical study report or performance testing documentation submitted as part of the 510(k) application, which is not included in this letter.

    Therefore, I cannot provide the requested information based solely on the text provided.

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