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510(k) Data Aggregation

    K Number
    K041961
    Device Name
    SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
    Manufacturer
    SCANDIUS BIOMEDICAL, INC.
    Date Cleared
    2004-10-20

    (91 days)

    Product Code
    HWC,MAI
    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

    The Scandius Absorbable ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.

    Device Description

    The Absorbable ACL Reconstruction System consists of a two piece implant. The femoral implant is designed to maintain the graft block in the femoral tunnel. A screw placed transversely to the femoral tunnel secures the graft block in place. The System includes instrumentation to create the bone tunnel and place the device as well as a sterilization tray.

    AI/ML Overview

    The provided document is a 510(k) summary for the Scandius Absorbable ACL Reconstruction System, submitted to the FDA in 2004. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data like bench testing. It is not a clinical study report for an AI/ML powered device, and therefore does not contain the information requested in the prompt regarding acceptance criteria, expert ground truth, sample sizes for training/test sets, or MRMC studies.

    The document explicitly states:

    • "Bench testing demonstrates that any minor technological differences do not... [raise] new questions of safety and effectiveness." (page 2 of 2)
    • "The following performance data was provided in support of the substantial equivalence determination: Mechanical ultimate failure strength. In-Vitro Analysis." (page 2 of 2)

    Therefore, I cannot provide the requested information for an AI/ML powered device study. The document only details mechanical and in-vitro performance data for a medical implant.

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