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510(k) Data Aggregation

    K Number
    K203605
    Device Name
    SteriTrak
    Manufacturer
    Arbutus Medical Inc.
    Date Cleared
    2021-04-23

    (134 days)

    Product Code
    JEC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K960385,K761088
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arbutus Medical Inc.

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

    SteriTrak is indicated for implantation through the skin and bone so that traction may be applied to the skeletal system.

    Device Description

    SteriTrak™ is a sterile, temporarily implantable Kirschner wire (K-wire). SteriTrak™ is intended to be implanted into the bone for the purposes of providing an anchor for skeletal traction. SteriTrak™ is intended to be inserted while the patient is in the Emergency Room, prior to admittance to the Operating Room for surgery. When the patient is transferred to the Operating Room for surgery, skeletal traction is released and SteriTrak™ is removed.

    The SteriTrak™ surgical grade 316L stainless steel pin is implantable up to 30 days. SteriTrak™ is provided with a guiding handle intended to be used as a pin stabilizing holder for the orthopedic surgeon.

    AI/ML Overview

    The provided text is a 510(k) summary for the SteriTrakTM device, a skeletal traction pin. It focuses on establishing substantial equivalence to predicate devices based on intended use, design, technological characteristics, and non-clinical performance testing. However, it does not contain information about acceptance criteria or a study that utilizes AI/ML for medical image analysis, which is the premise of your request.

    Specifically, the document does not provide the following information from your prompt:

    • A table of acceptance criteria and reported device performance (in the context of AI/ML).
    • Sample size used for the test set or data provenance for an AI/ML study.
    • Number of experts used to establish ground truth or their qualifications.
    • Adjudication method for a test set.
    • Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human readers with AI assistance.
    • Details about standalone (algorithm only) performance.
    • The type of ground truth used (expert consensus, pathology, outcomes data) for an AI/ML model.
    • Sample size for the training set of an AI/ML model.
    • How the ground truth for the training set was established for an AI/ML model.

    The document describes non-clinical performance testing such as:

    • Biocompatibility assessment to ISO 10993-1
    • Usability testing to IEC 62366-1
    • Pin torque transfer to ASTM F-138-19 and ISO 5832-1
    • Label legibility testing to ISO 14630:2012

    These tests are standard for a medical device cleared via the 510(k) pathway, demonstrating mechanical, biological, and user interface safety and efficacy, but they are not related to AI/ML performance evaluation.

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