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510(k) Data Aggregation

    K Number
    K112193
    Device Name
    ARROW REVERSE SHOULDER SYSTEM
    Manufacturer
    FOURNITURES HOSPITALIERES INDUSTRIE
    Date Cleared
    2012-07-12

    (349 days)

    Product Code
    PHX,KWS,KWT
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K053274,K073688,K063569,K062250,K093599
    Why did this record match?
    Device Name :

    ARROW REVERSE SHOULDER SYSTEM

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

    The ARROW® reverse shoulder prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented of cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

    Device Description

    The ARROW® reverse shoulder system is a shoulder joint prosthesis, composed of the following elements :

    • Humeral stems, ・
    • STD humeral inserts, •
    • Glenospheres -
    • Metal-back glenoid bases -
    • And fixation screws for the metal back glenoid base (cancellous and cortical bone screws)
      The ARROW® reverse shoulder system is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
    AI/ML Overview

    This document is a 510(k) premarket notification for the ARROW® Reverse Shoulder System, outlining its request for substantial equivalence to legally marketed predicate devices. It focuses on the device's design, materials, and mechanical performance, rather than clinical performance (e.g., diagnostic accuracy or treatment efficacy measured through patient outcomes).

    Therefore, the requested information regarding acceptance criteria for clinical performance, study types like MRMC, accuracy metrics, ground truth establishment, or training set details cannot be fully provided from this document. This document is primarily focused on demonstrating mechanical and material equivalence and safety.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (What was measured)Reported Device Performance (How the device performed)
    Mechanical performance of glenoid components per ASTM F1378-05"After the testing was completed, it was determined that the ARROW reverse shoulder system performances were substantially equivalent to those of the selected predicated devices."
    Mechanical performance of glenoid components per ASTM F1829-98"After the testing was completed, it was determined that the ARROW reverse shoulder system performances were substantially equivalent to those of the selected predicated devices."

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

    • Sample Size: Not explicitly stated for each test (ASTM F1378-05 and ASTM F1829-98). Mechanical testing standards typicaly specify the number of samples to be tested, but this document does not provide the specific number of ARROW® devices tested.
    • Data Provenance: The device manufacturer, Fournitures Hospitalières Industrie, is based in Quimper, France. The testing was conducted internally or by a third-party laboratory usually located in the country of origin or a specialized testing facility. Details about the exact location of testing are not provided. The study is a prospective engineering study (i.e., testing of the device for regulatory submission) not a clinical study.

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

    • Not applicable (N/A). This is a mechanical/material engineering study, not a study requiring expert clinical ground truth evaluation. The "ground truth" for these tests are the established parameters and failure modes defined by the ASTM standards, which are objective and quantitative.

    4. Adjudication Method for the Test Set

    • N/A. Adjudication methods like 2+1 or 3+1 are used in clinical studies for expert consensus, which is not relevant for mechanical testing against industry standards. The compliance with the ASTM standards is objectively measured.

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

    • No. This document focuses on demonstrating mechanical equivalence and safety for a medical device (reverse shoulder system). MRMC studies are typically performed for diagnostic imaging devices or AI-assisted diagnostic tools to assess the impact of the technology on human reader performance.

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

    • N/A. This is a physical medical device, not an algorithm. Standalone performance analysis is not applicable here.

    7. The Type of Ground Truth Used

    • Established ASTM (American Society for Testing and Materials) Standards for mechanical performance. The device's performance was compared against the requirements and benchmarks set by these recognized industry standards (F1378-05 and F1829-98) and against the performance of predicate devices.

    8. The Sample Size for the Training Set

    • N/A. This device does not involve a "training set" in the context of machine learning or AI.

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

    • N/A. This device does not involve a "training set" or "ground truth" in the context of machine learning for which such establishment would be necessary.
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