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510(k) Data Aggregation

    K Number
    K170040
    Device Name
    BePOD Cannulated Arthrodesis Screws
    Manufacturer
    Fournitures Hospitalieres Industrie
    Date Cleared
    2017-04-04

    (89 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K120740,K070617
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Arthrodesis cannulated screws are designed for the following indication: Arthrodesis of the metatarsal-phalangeal joint of the big toe.

    Device Description

    BePOD® Cannulated Arthrodesis Screws includes the following elements: BePOD® Arthrodesis cannulated screws. The BePOD® Cannulated Arthrodesis Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device, specifically the BePOD® Cannulated Arthrodesis Screws. Such notifications typically focus on demonstrating substantial equivalence to a predicate device rather than providing detailed studies on a device's performance against specific acceptance criteria for AI algorithms.

    Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance is not applicable to this document.

    This document describes a traditional medical device (screws for bone fixation), not an AI/ML-driven device. The "Performance" section refers to material testing (LAL testing) and compliance with manufacturing regulations, not performance metrics based on data analysis or AI algorithms.

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