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510(k) Data Aggregation

    K Number
    K163293
    Device Name
    Colink™ Plating System
    Manufacturer
    IN2BONESUSA, LLC
    Date Cleared
    2017-05-05

    (164 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K131920,K153609,K161426,K083447,K123000
    Why did this record match?
    Reference Devices :

    K131920, K153609, K161426

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

    The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

    Device Description

    The In2Bones CoLink™ Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the bones of the extremities.

    AI/ML Overview

    1. Table of Acceptance Criteria and Reported Device Performance

    Test TypeAcceptance Criteria (Implied)Reported Device Performance
    Bacterial EndotoxinDevice meets biocompatibility requirements.Testing performed; results demonstrate substantial equivalence.
    Static Driving TorqueDevice components (screws) can be appropriately driven without failure, supporting the intended fixation.Testing performed; results demonstrate substantial equivalence.
    Static PulloutScrews maintain adequate fixation in bone material under static axial loads, ensuring stability.Testing performed; results demonstrate substantial equivalence.
    Static TorsionScrews and plates withstand torsional forces without failure, relevant for rotational stability.Testing performed; results demonstrate substantial equivalence.
    Screw/Plate Push ThroughScrews do not "push through" the plate, maintaining the integrity of the fixation construct.Testing performed; results demonstrate substantial equivalence.
    Static BendingPlates and screws maintain mechanical integrity and resist deformation under static bending loads, crucial for fracture stabilization.Testing performed; results demonstrate substantial equivalence.
    Pullout Fixation (General)The overall construct (plate and screws) provides secure and stable fixation in bone.Testing performed; results demonstrate substantial equivalence.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not explicitly state the specific sample sizes used for each mechanical test. It only generally refers to "testing" being performed. The data provenance is pre-market (regulatory submission for 510(k) clearance), suggesting it's from studies conducted by the device manufacturer, In2Bones USA, LLC. The country of origin of the data is not specified but would typically be where the manufacturer's testing facilities are located or where contract research organizations (CROs) performed the tests. The studies are prospective in nature, meaning they were designed and conducted specifically to generate data for this regulatory submission.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    This information is not applicable. The device being described is a mechanical bone fixation system (plates and screws), not a diagnostic or AI-driven device that requires expert-established ground truth for performance evaluation in a clinical or imaging context. The "ground truth" for this type of device is established through engineering and mechanical testing standards and simulations rather than expert consensus on clinical findings.

    4. Adjudication Method for the Test Set

    This information is not applicable for the reasons mentioned in point 3. The evaluation of mechanical test results typically involves adherence to recognized standards and objective measurements, not adjudication by human experts in the way clinical studies are adjudicated.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human readers in interpreting medical images or data. The Colink™ Plating System is a surgical implant, and its effectiveness is assessed through mechanical testing and, if applicable, clinical performance data (which is not detailed here beyond the substantial equivalence claim).

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

    This information is not applicable. The Colink™ Plating System is a physical medical device, not an algorithm. Therefore, there is no "standalone" algorithm-only performance to assess.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's performance evaluation is established through objective, standardized mechanical testing data (e.g., measurements of force, torque, displacement) against pre-defined engineering specifications and relevant industry standards for orthopedic implants. It is not based on expert consensus, pathology, or outcomes data in the context of this 510(k) summary, which focuses on substantial equivalence based on technological characteristics and mechanical performance.

    8. The Sample Size for the Training Set

    This information is not applicable. The Colink™ Plating System is an orthopedic implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data acquisition for AI model development.

    9. How the Ground Truth for the Training Set was Established

    This information is not applicable for the reasons mentioned in point 8.

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