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510(k) Data Aggregation

    K Number
    K200361
    Device Name
    Akros Scruture Anchor LisFranc Repair Kit
    Manufacturer
    Akros Medical
    Date Cleared
    2020-04-06

    (52 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K162805,K061925
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K162805

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

    The Akros Scruture Anchor LisFranc Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external fixation systems involving plates, with fracture braces and casting. Specifically, the Akros Scruture Anchor LisFranc Repair Kit is intended to provide fixation during the healing process following Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction).

    Device Description

    The Akros Scruture Anchor Lisfranc Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the bones of the midfoot during the healing process following a Lisfranc injury. The design of the implant permits placement through any fracture repair plate that can accept a 4.0mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter and summary for a medical device called the "Akros Scruture Anchor LisFranc Repair Kit."

    Based on the content of the document, the device described is a metallic bone fixation appliance, not an Artificial Intelligence/Machine Learning (AI/ML) enabled device. Therefore, the information typically required for an AI/ML device's acceptance criteria and study proving its performance (such as ROC curves, sensitivity/specificity, sample sizes for AI model training/testing, expert ground truth establishment, etc.) is not present in this document.

    The document focuses on the substantial equivalence of this physical implant device to a predicate device, primarily through non-clinical testing (e.g., mechanical testing, biocompatibility).

    Here's what can be extracted, acknowledging the nature of the device:

    1. A table of acceptance criteria and the reported device performance

    The document does not provide a table with quantitative acceptance criteria and reported device performance in the manner expected for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it states that:

    Acceptance Criteria Category (for physical device)Reported Device Performance (Summary)
    Mechanical Performance Testing (e.g., pull-to-failure, load-to-failure, torque, fatigue, fretting, pitting corrosion)"The results of these tests indicate that the performance of the Scruture Anchor device is adequate for its intended use." Data was adopted from a reference device due to design similarity.
    Biocompatibility (e.g., cytotoxicity, pyrogenicity, bacterial endotoxin)"Results demonstrated that the reference device meets an endotoxin limit of <20 EU/device." (For Bacterial Endotoxin Testing)

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

    • Test Set (for AI/ML): Not applicable. This is a physical implant device, not an AI/ML algorithm.
    • Data Provenance: The testing appears to be primarily lab-based (non-clinical) mechanical and chemical testing, rather than human subject data or image data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

    • Not applicable. Ground truth in the context of expert review for AI/ML performance is not relevant for this physical device's evaluation. Its "performance" is assessed through engineering and material science tests.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable. No expert adjudication process is described as this is not an AI/ML device relying on human interpretation for ground truth.

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

    • No. This device is a bone fixation kit, not an AI-assisted diagnostic or prognostic tool. Therefore, MRMC studies are irrelevant.

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

    • Not applicable. There is no algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • The "ground truth" for this device's performance is established by standardized material and mechanical testing methods (e.g., ASTM standards for mechanical properties like pull-to-failure, torque-to-failure) and biocompatibility tests. It is not based on expert consensus, pathology, or clinical outcome data in the context of "ground truth" for an AI model.

    8. The sample size for the training set

    • Not applicable. This device does not involve a training set for an AI model.

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

    • Not applicable. There is no training set for an AI model.
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