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510(k) Data Aggregation

    K Number
    K990355
    Device Name
    STAINLESS STEEL SOFT SUTURE WIRE
    Manufacturer
    BREGMA INTERNATIONAL TRADING COMPANY LTD.
    Date Cleared
    1999-07-08

    (153 days)

    Product Code
    LRN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STAINLESS STEEL SOFT SUTURE WIRE

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

    The Stainless Steel Soft Suture Wire is intended for general orthopedic surgery such as Sternulli Closure, nature bones and patella fracture fixation. The device is also intended for soft tissue approximation such as abdominal wound closure and hernia repair.

    Device Description

    Suture Wire (87 LRN)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Stainless Steel Soft Suture Wire." It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information about acceptance criteria, device performance studies, or details regarding ground truth, expert opinions, or sample sizes.

    Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the input document. The document is a regulatory approval, not a technical report detailing performance studies.

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