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510(k) Data Aggregation

    K Number
    K133668

    Validate with FDA (Live)

    Device Name
    AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL
    Manufacturer
    SHOULDER OPTIONS, INC.
    Date Cleared
    2014-03-03

    (94 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K121672,K963172,K052483
    Predicate For
    K163361,K223933
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AFT™ Greater Tuberosity Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.

    The AFT™ Greater Tuberosity Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

    Device Description

    The AFT™ Greater Tuberosity Fracture System (AFT-GTF) consists of anatomically shaped plates which are fixated with 3.5mm or 4.5mm locking screws and 4.5mm diameter non-locking screws. 4.5mm Cannulated screws are provided to be used with or without 10mm washers. The anatomic plate contains multiple holes to allow for suturing. It is available in left and right configurations. The fasteners are available in various lengths. All components are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for singleuse.

    AI/ML Overview

    The provided text is a 510(k) summary for the "AFT™ Greater Tuberosity Fracture System," which is a cannulated bone screw and plate system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study on device performance against specific acceptance criteria.

    Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), and training set information is not present in the provided 510(k) summary.

    Instead, the document states:

    • Acceptance Criteria/Performance: Not explicitly defined or measured with a study detailed in the way requested. The core of the submission is demonstrating "geometric equivalence and engineering rationale" and "substantial equivalence" to predicate devices.
    • Study Data Summary: "Geometric equivalence and engineering rationale is provided to demonstrate substantial equivalence." This refers to comparative analysis of design, materials, and intended use against existing, approved devices, not a clinical performance study with defined acceptance criteria and statistical outcomes.

    In summary, the provided document does not contain the information required to populate the requested table and answer the specific study-related questions. It's a regulatory submission demonstrating equivalence, not a clinical trial report.

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