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510(k) Data Aggregation

    K Number
    K013903
    Device Name
    HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
    Manufacturer
    TRIAD MEDICAL, INC.
    Date Cleared
    2001-12-17

    (21 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2

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

    This device is used in the general management of fractures and reconstructive surgery.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Helical Compression Anchor System, Cannulated, Version 2." It primarily states that the device has been found substantially equivalent to a legally marketed predicate device for the stated indications for use.

    The document does not include:

    1. A table of acceptance criteria or reported device performance.
    2. Details about sample sizes, data provenance, or types of studies conducted (e.g., test set, ground truth experts, adjudication methods, MRMC studies, standalone performance).
    3. Information on the training set or how its ground truth was established.

    The "Indications for Use Statement" only provides the general purpose of the device: "This device is used in the general management of fractures and reconstructive surgery." This is an intended use statement, not a list of performance acceptance criteria.

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