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510(k) Data Aggregation

    K Number
    K091889
    Device Name
    DRX-EVOLUTION, MODEL VX3733-SYS
    Manufacturer
    CARESTREAM HEALTH, INC.
    Date Cleared
    2009-07-20

    (26 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K051258,K090318
    Why did this record match?
    Device Name :

    DRX-EVOLUTION, MODEL VX3733-SYS

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

    The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

    Device Description

    The DRX-Evolution is a diagnostic x-ray system utilizing digital radiography (DR) technology. The DRX-Evolution is designed for horizontal and upright projections. It consists of a high frequency x-ray generator, overhead tube crane (with x-ray tube assembly), elevating 4-way float radiographic table with detector tray, tilting Bucky receptor on an upright Wall Stand, and x-ray controls containing a power distribution unit and operator PC.

    AI/ML Overview

    Due to the nature of the submitted document, which is a 510(k) summary for a diagnostic X-ray system, the information typically found in a study demonstrating how a device meets acceptance criteria for an AI/CADe (Computer-Aided Detection/Diagnosis) system is not present.

    This document describes a conventional diagnostic X-ray system (DRX-Evolution) and its substantial equivalence to predicate devices, focusing on hardware components and intended use. It is not an AI/CADe device, and therefore, the concepts of "acceptance criteria" and a "study to prove the device meets acceptance criteria" as defined in the prompt for AI/CADe are not applicable here.

    The "Discussion of Testing" mentions "Predefined acceptance criteria was met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device." However, these acceptance criteria relate to the performance of an X-ray system (e.g., image quality, radiation output, mechanical safety, software functionality), not the diagnostic performance of an AI algorithm based on sensitivity, specificity, or other metrics typically used for AI/CADe.

    Therefore, I cannot provide the requested information regarding AI/CADe specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as this device does not appear to incorporate such AI technology requiring these types of evaluations.

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