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510(k) Data Aggregation

    K Number
    K152253
    Device Name
    Biomet Microfixation RibFix Blu Thoracic Fixation System
    Manufacturer
    BIOMET MICROFIXATION
    Date Cleared
    2016-03-24

    (227 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K142823,K151173
    Why did this record match?
    Reference Devices :

    K142823, K151173

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

    The Biomet Microfixation RibFix Blu Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.

    Device Description

    The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).

    AI/ML Overview

    This document is a 510(k) summary for the Biomet Microfixation RibFix Blu Thoracic Fixation System. It describes a medical device, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.

    Therefore, I cannot provide the requested information in the format of acceptance criteria and reported device performance because the document does not discuss these concepts for an AI/ML device.

    Here's why the provided text is not relevant to your request for AI/ML device performance:

    • Device Type: The Biomet Microfixation RibFix Blu Thoracic Fixation System is a physical medical device (metallic plates and screws for bone fixation). It is not an AI/ML algorithm or software.
    • Performance Data: The document states, "Non-Clinical Performance Data: MRI simulation and physical testing were performed to support the MR Safety Information in the labeling. Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence." This refers to physical and material performance, not algorithmic performance.
    • Lack of AI/ML Specifics: There is no mention of algorithms, machine learning, data sets (training or test), ground truth, experts for annotation, or any other terms relevant to AI/ML device evaluation.

    If you have a document about an AI/ML medical device, I would be happy to analyze it according to your requested format.

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