LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K202489
    Device Name
    AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System
    Manufacturer
    Advanced Orthopaedic Solutions, Inc.
    Date Cleared
    2020-10-26

    (56 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K152732,K021008,K052390,K082624
    Why did this record match?
    Device Name :

    AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System

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

    The AOS Fibonacci Proximal Tibia Plating System is intended for the fixation of fractures, malunions, osteopenic bone, and tibial osteotomies of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

    Device Description

    The AOS Proximal Tibia Plating System consists of precontoured, single use, open reduction internal fixation Lateral Proximal Tibia Plates and Posteromedial Proximal Tibia Plates, manufactured from titanium alloy, and AOS Fibonacci screws 3.5mm in diameter or larger. These plates and screws, and their dedicated accessories and sterilization trays, will be added to the AOS Fibonacci Lower Extremity Plating System. The 4.0mm Fixed Angle Locking Screws are single use titanium alloy orthopedic fixation screws, designed for use with all plates in the Fibonacci Lower Extremity Plating System, including the proximal tibia plates. The 3.5mm Diamond Workhorse Screws are single use titanium alloy orthopedic fixation screws with a faceted cut core diameter, designed for use with all plates in the Fibonacci Lower Extremity Plating System, including the proximal tibia plates.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Test Type)Reported Device Performance (Summary)
    Static Four-Point Bend Testing (per ASTM F382)Results, alongside other tests, demonstrated substantial equivalence to predicate devices.
    Fatigue Four-Point Bend Testing (per ASTM F382)Results, alongside other tests, demonstrated substantial equivalence to predicate devices.
    Torsion Strength Testing (per ASTM F543)Results, alongside other tests, demonstrated substantial equivalence to predicate devices.
    Insertion Torque Testing (per ASTM F543)Results, alongside other tests, demonstrated substantial equivalence to predicate devices.
    Pullout Strength Testing (per ASTM F543)Results, alongside other tests, demonstrated substantial equivalence to predicate devices.
    Internal Engineering Analysis (Not a specific test)Contributed to the overall demonstration of substantial equivalence.

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

    The document does not explicitly state the specific sample sizes for each test. It generally refers to "the AOS Proximal Tibia Plating System" being subjected to various tests. The data provenance is not specified (e.g., country of origin). The testing described is prospective as it was conducted to demonstrate substantial equivalence for a new device submission.

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

    Not applicable. This device is a metallic bone fixation appliance, and the "ground truth" is established through mechanical and engineering performance testing, not through expert human assessment of images or clinical outcomes in the same way an AI diagnostic device would be.

    4. Adjudication Method for the Test Set

    Not applicable. As noted above, the assessment is based on objective mechanical testing against established standards (ASTM F382, ASTM F543) rather than human adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

    No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers' performance is being evaluated with and without AI assistance. This document describes a medical device (bone plating system) where performance is assessed through physical and mechanical testing.

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

    Not applicable. This is not an algorithm or AI device. The document describes the mechanical performance of a physical medical implant.

    7. The Type of Ground Truth Used

    The "ground truth" in this context is defined by the performance requirements outlined in the referenced ASTM standards (ASTM F382 for static and fatigue bending, and ASTM F543 for torsion, insertion torque, and pullout strength). The performance of the predicate devices, which are legally marketed, also serves as a benchmark for "ground truth" in the substantial equivalence argument.

    8. The Sample Size for the Training Set

    Not applicable. This is not an AI or machine learning device and therefore does not have a "training set" in that sense.

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

    Not applicable. There is no training set for this type of device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1