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510(k) Data Aggregation

    K Number
    K233659
    Device Name
    Suture Wing
    Manufacturer
    OSTEONIC Co., Ltd.
    Date Cleared
    2023-12-26

    (41 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K231326,K110879,K202663
    Why did this record match?
    Reference Devices :

    K231326, K110879

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

    Suture wing is intended for fixation of soft tissue to bone, using suture, in orthopedic surgery.

    Device Description

    This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The anchor and sutures is made of non-absorbable and consists of Driver Shaft for anchor insertion. This product is sterilized product and single use only.

    Sterile bone anchor-all suture is supplied EO gas sterile state and it was packed in tyvek and PE film.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for a medical device called "Suture Wing." This document focuses on demonstrating substantial equivalence to a previously cleared device, not on proving that the device meets specific acceptance criteria based on a study involving AI or human readers.

    Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving the device meets those criteria (especially in the context of AI performance, human reader studies, and ground truth establishment) is NOT present in the provided document.

    The document details non-clinical bench tests to verify design specifications and compliance with various standards related to materials, mechanical performance, sterilization, shelf-life, packaging, bacterial endotoxin, and pyrogenicity. It explicitly states: "Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

    It describes the comparison to a predicate device and a reference device, indicating similarities and minor differences in material (needle presence, which is addressed by the reference device) and product size, with the safety of these differences evaluated through bench testing.

    In summary, this document is a regulatory submission for a physical medical device (Suture Wing) establishing substantial equivalence based on bench testing and comparison to predicates, not a study evaluating AI or human reader performance.

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