LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K123110
    Device Name
    PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301
    Manufacturer
    SURGICAL INNOVATIONS PLC
    Date Cleared
    2013-01-17

    (106 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301

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

    The device is designed as an organ and tissue retractor for the use in minimally invasive surgical procedures to elevate or retract organs and tissues to provide better access as well as visualisation of surgical sites.

    Device Description

    Pretzelflex Surgical Retractor

    AI/ML Overview

    I'm sorry, but your request cannot be fulfilled. The document provided does not contain the necessary information to describe the acceptance criteria and the study that proves the device meets those criteria. Specifically, it is a 510(k) clearance letter for a surgical retractor, which focuses on regulatory approval based on substantial equivalence to a predicate device.

    The document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Details about sample sizes, data provenance, number of experts, adjudication methods, or MRMC studies.
    3. Information on standalone algorithm performance or the type of ground truth used.
    4. Information about training set size or how its ground truth was established.

    Therefore, I cannot extract the requested information from the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1