LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K202716
    Device Name
    Ignite Anatomic Shoulder System
    Manufacturer
    Ignite Orthopedics LLC
    Date Cleared
    2021-05-20

    (245 days)

    Product Code
    MBF,HSD,KWS,KWT,PAO
    Regulation Number
    888.3670
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K060692,K060694,K060716,K162024,K111596,K091196,K122698,K905786,K052472,K121183
    Why did this record match?
    Device Name :

    Ignite Anatomic Shoulder System

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

    The Ignite Anatomic Shoulder System is intended for use in total or hemi-shoulder replacement procedures the following:

    • · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
    • · Rheumatoid arthritis.
    • · Revision where other devices or treatments have failed.
    • · Correction of functional deformity.
    • · Fracture of the humeral head
    • · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

    Fixation Methods
    The humeral stem is intended for cementless use. The glenoid is intended for cemented use only.

    Device Description

    The Ignite Anatomic Shoulder System is total shoulder arthroplasty system consisting of humeral heads (38 - 57mm diameters), offset taper adapters (multiple offsets), stems (66-82mm lengths), and glenoid components (multiple sizes).

    The anatomic humeral consists of a wrought Cobalt-Chromium Humeral Head, a wrought Ti-6Al-4V Taper Adapter, and an additively manufactured Ti-6Al-4V Stem.

    The All-Poly Anatomic Glenoid consists of Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene. This device also has a 316L stainless steel pin pressed into it as an x-ray marker.

    The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.

    AI/ML Overview

    The provided FDA 510(k) document is for the Ignite Anatomic Shoulder System, a medical device. This document describes the device itself and its equivalence to previously cleared devices. It does not contain information about an AI/ML powered device or a study involving acceptance criteria for such a device.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

    The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Ignite Anatomic Shoulder System to the predicate devices." This indicates that the regulatory clearance was based on non-clinical testing and comparison to predicate devices, not on a clinical study evaluating its performance against specific acceptance criteria in patient populations.

    The "Non-Clinical Testing" section lists various mechanical and material-related tests (e.g., Range of Motion, Biocompatibility, Wear Testing, Fatigue Testing) conducted to demonstrate the device's substantial equivalence to predicate devices, but these are for the physical implant itself, not an AI/ML component.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1