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510(k) Data Aggregation

    K Number
    K212197
    Device Name
    WasherCap Fixation System
    Manufacturer
    Abanza Tecnomed SL.
    Date Cleared
    2022-09-22

    (435 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K130217
    Predicate For
    K243712,K250238
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.

    Device Description

    WasherCap™ Fixation System is an implantable device indicated for soft tissue graft fastening during Anterior Cruciate Ligament repair surgery.

    WasherCap™ Fixation System consists of three components: a Cap, a Screw and a Washer. The Cap and the Washer are manufactured from polyetheretherketone (PEEK) as per ASTM F-2026. The Screw is made of titanium alloy as per ASTM F136.

    The WasherCap™ Fixation System is provided sterile and individually packaged and, it is available in a variety of sizes and should be implanted following the surgical procedure.

    AI/ML Overview

    The provided text describes the WasherCap™ Fixation System, a medical device intended for fixation of soft tissue grafts during ACL reconstruction. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the context of an AI/ML-driven medical device.

    The document appears to be an FDA 510(k) clearance letter and summary for a physical medical device (WasherCap™ Fixation System), not an AI/ML diagnostic or assistive device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to the content provided.

    Specifically, the document states:

    • "No clinical studies were conducted." This directly indicates that there aren't clinical performance metrics to discuss.
    • "Performance Data" section lists "DESIGN VALIDATION" and "PERFORMANCE TESTING" (Cyclic and load-to-failure properties), and "PYROGENICITY" tests. These are mechanical and biological safety tests for a physical implant, not performance metrics for an AI/ML algorithm.

    Therefore, I cannot provide the requested information based on the given input. The prompt's questions are designed for AI/ML device evaluations, and the provided document pertains to a traditional physical medical device.

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