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510(k) Data Aggregation

    K Number
    K141920
    Device Name
    Wrist Hemiarthroplasty System
    Manufacturer
    ARTHROSURFACE, INC.
    Date Cleared
    2014-12-23

    (160 days)

    Product Code
    KWN,KWO
    Regulation Number
    888.3750
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K050028
    Why did this record match?
    Reference Devices :

    K050028

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

    Indicated for use as a partial replacement of wrist joint(s) disabled by pain, deformity and/or limited motion caused by:

    • Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis
    • Rheumatoid arthritis .
    • Revision where other devices or treatments have failed ●
    • Scapholunate Advanced Collapse (SLAC) and other functional deformities ●
    • Trauma, including fractures of the carpal bones ●
      The device is a single use implant intended to be used with bone cement.
    Device Description

    The Arthrosurface HemiCAP® Wrist Hemiarthroplasty System consists of a contoured articular implant designed to articulate with the natural radius bone, a taper post and set of instruments used for implant site preparation and delivery. The resurfacing components are manufactured using implant grade cobalt-chrome alloy and will be offered in two diameters, and four articular radii. The taper post is manufactured using implant grade titanium alloy and is offered in one fixed size designed to work with all resurfacing implants.

    AI/ML Overview

    This document describes the Arthrosurface Wrist Hemiarthroplasty System, a medical device for partial wrist joint replacement. The provided text details the device's indications for use and compares it to a predicate device to establish substantial equivalence. However, it does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy).

    Instead, the document focuses on non-clinical tests performed to demonstrate safety and effectiveness and substantial equivalence to a predicate device.

    Here's a breakdown of the requested information based on the provided text, noting where information is not available:

    1. Table of Acceptance Criteria and Reported Device Performance

    Formal "acceptance criteria" for performance (like diagnostic accuracy metrics: sensitivity, specificity) and "reported device performance" are not explicitly stated or measured in the provided document. The document focuses on demonstrating substantial equivalence through mechanical testing and similarity in design and materials to a predicate device.

    Acceptance Criteria (e.g., Performance Thresholds)Reported Device Performance
    Not explicitly defined in terms of system performance like accuracy, sensitivity, specificity, or clinical outcomes.The non-clinical tests demonstrated "safety and effectiveness" and "substantial equivalence to the predicate device." Specific numerical results such as force in N for resistance to torque or cycles for dynamic fatigue are not provided in this summary.
    For example, specific thresholds for:Not provided in the summary.
    - Axial Assembly / Disassembly force
    - Resistance to Torque (e.g., minimum torque)
    - Static Compression (e.g., maximum load without failure)
    - Dynamic Fatigue (e.g., cycle count without failure)
    - Fretting & Corrosion (e.g., wear rates, corrosion levels)

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

    This information is not applicable in the context of the provided document, as it describes a non-clinical, mechanical testing study, not a clinical study involving a "test set" of patient data. The tests were performed on the device components themselves.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    This information is not applicable. Ground truth, in the context of diagnostic performance, is not relevant to the non-clinical mechanical testing described.

    4. Adjudication Method for the Test Set

    This information is not applicable for the reasons stated above.

    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

    This information is not applicable. The device is a physical implant (Wrist Hemiarthroplasty System), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

    This information is not applicable. The device is a physical implant, not an algorithm.

    7. The Type of Ground Truth Used

    This is not applicable in the context of a clinical "ground truth" for diagnostic performance. For the mechanical tests, the "ground truth" would be the known physical properties and performance standards for similar orthopedic implants, verified by engineering and material science principles. However, the exact standards or specifications used as "ground truth" for "safety and effectiveness" are not detailed in this summary.

    8. The Sample Size for the Training Set

    This information is not applicable as there is no "training set" for an AI model for this physical medical device.

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

    This information is not applicable for the reasons stated above.

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