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510(k) Data Aggregation

    K Number
    K151601
    Device Name
    SECURE-LOOP
    Manufacturer
    XIROS LTD
    Date Cleared
    2015-09-09

    (89 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K980155
    Why did this record match?
    Device Name :

    SECURE-LOOP

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

    The SECURE-LOOP is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.

    Device Description

    The SECURE-LOOP fixation device consists of a polyester continuous loop captured on a titanium alloy button. The button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The SECURE-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.

    AI/ML Overview

    The provided text describes the SECURE-LOOP device and its substantial equivalence to a predicate device, the Smith & Nephew Endobutton Continuos Loop (ECL) K980155. It focuses on comparing the technological characteristics and performance of the SECURE-LOOP with the predicate device rather than presenting specific acceptance criteria and a study to prove they are met in a traditional sense.

    Instead of a typical AI/ML device study, the document describes a device equivalency study based on pre-clinical testing for a medical fastener.

    Here's an analysis based on the information provided, formatted to answer your questions where applicable:

    Acceptance Criteria and Device Performance

    The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical thresholds. Instead, the criterion for the SECURE-LOOP device is substantial equivalence to the predicate device (Smith & Nephew Endobutton Continuos Loop (ECL) K980155) across several performance characteristics.

    Acceptance Criteria (Implied for Substantial Equivalence)Reported Device Performance (SECURE-LOOP vs. Predicate)
    Stiffness equivalenceDetermined to be substantially equivalent to Endobutton Continuous Loop (ECL)
    Tensile strength equivalenceDetermined to be substantially equivalent to Endobutton Continuous Loop (ECL)
    Cyclic fatigue testing equivalenceDetermined to be substantially equivalent to Endobutton Continuous Loop (ECL)
    Functional testing equivalenceDetermined to be substantially equivalent to Endobutton Continuous Loop (ECL)
    No new issues of safety and efficacyTesting demonstrated that differences do not raise any new issues of safety and efficacy.
    Similar safety and effectiveness profileBased on pre-clinical testing, found to have a safety and effectiveness profile similar to predicate device

    Study Details:

    1. Sample size for the test set and data provenance:
      The document does not specify the exact sample sizes (i.e., number of devices or test repetitions) used for the stiffness, tensile strength, cyclic fatigue, and functional testing.
      The provenance of the data (country of origin, retrospective/prospective) is not mentioned beyond stating "pre-clinical testing."

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
      This is not applicable as the study involves device performance testing against a predicate, not human expert interpretation for ground truth establishment.

    3. Adjudication method for the test set:
      Not applicable, as it is a physical device performance comparison, not a ground truth establishment process involving multiple experts.

    4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
      No, an MRMC study was not done. This type of study is typically for diagnostic imaging devices involving interpretation by multiple human readers, which is not relevant for this orthopedic fixation device.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
      This question is generally relevant for AI/ML algorithms. For this physical device, the "standalone performance" is implicitly what was measured in the pre-clinical tests (stiffness, tensile strength, cyclic fatigue, functional testing) where the device's properties were characterized without human intervention in its function.

    6. The type of ground truth used:
      The "ground truth" in this context is the established performance characteristics of the predicate device which the SECURE-LOOP device is attempting to demonstrate equivalence to. The performance parameters (stiffness, tensile strength, cyclic fatigue, functional performance) of both the SECURE-LOOP and the predicate device are determined through laboratory-based physical/mechanical testing.

    7. The sample size for the training set:
      The concept of a "training set" is not applicable here as this is not an AI/ML device. The testing described is for performance validation, not for training a model.

    8. How the ground truth for the training set was established:
      Not applicable, as there is no training set for an AI/ML model.

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