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510(k) Data Aggregation

    K Number
    K973005
    Device Name
    THE CORIFIX LIGAMENT ANCHOR
    Manufacturer
    CORIN U.S.A.
    Date Cleared
    1997-11-10

    (89 days)

    Product Code
    HWC,HMC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in conjunction with the patient's medial hamstring tendons, namely semitendinosus and gracilis, by securing the looped tendons to the femur and tibia in order to repair damaged anterior and posterior cruciate ligaments.

    Relief of pain and restoration of knee finction arising from damage to anterior of posterior cruciate ligaments,

    Device Description

    A Ligament Anchor system comprising a range of Ligament Anchors, Ligament Staples (Claws) and Bone Screws.

    The devices are used in conjunction with the patient's medial hamstring tendons, namely semitendinosus and gracilis. by securing the looped tendons to the femur and tubia in order to repair damaged anterior and posterior cruciate ligaments.

    A dedicated Ligament Claw Impactor is used during unpaction of the Ligament Claw into the patient's femur.

    Each of the implantable devices is manufactured from titanium which is certified to BS 7252 Part 3 (ISO 5832 Part 3)

    Reconstruction of the anterior and posterior cruciate ligaments using the Corifix Ligament Anchor System allows immediate post-operative early joint motion and early weight bearing

    AI/ML Overview

    The provided text is a 510(k) premarket notification for the Corifix Ligament Anchor System and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a modern AI/ML device submission would. This document is from 1997 and focuses on substantial equivalence to a predicate device rather than detailed performance studies with acceptance criteria, ground truth, or expert review for AI/ML algorithms.

    Therefore, many of the requested categories cannot be filled from the provided text.

    Here's an attempt to answer based on the available information, with clear indications where the information is not provided in the document:

    1. Table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Not provided. The document focuses on substantial equivalence to a predicate device, not specific quantitative performance criteria. It mentions "mechanical test data and clinical results confirming the device's safety and effectiveness" but does not detail these or present acceptance criteria for them.The device has been in clinical use outside the USA for approximately four years, and "no significant post-operative problems have been reported."

    2. Sample size used for the test set and the data provenance

    • Sample size for test set: Not provided. The submission states there are "clinical results" and that the device has been in use for four years, implying a real-world clinical test set, but no specific numbers are given for a formal study.
    • Data provenance: "Outside the USA" (for approximately four years) for the clinical use. Implied to be retrospective from clinical experience.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Number of experts: Not provided.
    • Qualifications of experts: Not provided.

    4. Adjudication method for the test set

    • Adjudication method: Not provided.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

    • MRMC study: Not performed/described. This type of study is relevant for AI/ML devices influencing human interpretation, which is not the case for a ligament anchor system.
    • Effect size: Not applicable.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

    • Not applicable. This is a medical device (ligament anchor system), not an AI/ML algorithm.

    7. The type of ground truth used

    • Type of ground truth: Not explicitly stated as "ground truth" in the modern sense. However, the basis for effectiveness and safety appears to be:
      • Substantial equivalence to a legally marketed predicate device (Linvatec Concept 6.5mm Screw and Spiked Washer Anchoring Implant).
      • Mechanical test data.
      • Clinical use data ("no significant post-operative problems have been reported" over approximately four years outside the USA).

    8. The sample size for the training set

    • Sample size for training set: Not applicable in the context of an AI/ML device. For a physical device, the "training" would be the design and development based on engineering principles and existing device knowledge. The provided text does not quantify this.

    9. How the ground truth for the training set was established

    • How ground truth for training set was established: Not applicable in the context of an AI/ML device. The design of the Corifix Ligament Anchor System was likely based on:
      • Engineering design principles for medical implants.
      • Characteristics of the predicate device.
      • Understanding of existing surgical techniques and anatomical requirements for ACL/PCL repair.
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