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510(k) Data Aggregation

    K Number
    K182591
    Device Name
    RadiForce RX360, RX360-AR
    Manufacturer
    EIZO Corporation
    Date Cleared
    2018-10-18

    (28 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    K153354
    Why did this record match?
    Device Name :

    RadiForce RX360, RX360-AR

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

    This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

    Device Description

    RadiForce RX360 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 mm.

    Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.

    There are two model variations, RX360 and RX360-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX360 is Anti-Glare (AG) treatment and that of the RX360-AR is Anti-Reflection (AR) coating.

    RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX360 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce RX360.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the EIZO RadiForce RX360 and RX360-AR displays. This document focuses on demonstrating substantial equivalence to a predicate device (EIZO RadiForce RX350) for displaying radiological images. It does not describe an AI medical device, nor does it present a study that uses AI to improve diagnostic performance.

    Therefore, I cannot fulfill your request for information related to AI device acceptance criteria, human reader improvement with AI, or standalone AI performance, as these topics are not addressed in the provided text.

    However, I can extract information regarding the performance testing of the EIZO RadiForce RX360 displays, as described in section 7 ("Performance Testing"):

    Table of Acceptance Criteria and Reported Device Performance

    Feature/TestAcceptance Criteria (not explicitly quantified in the document, but implied by "meet pre-defined criteria")Reported Device Performance
    Spatial Resolution (MTF)Meet pre-defined criteria"has display characteristics equivalent to those of the predicate device"
    Pixel Defects/Faults"The maximum number allowed for each type of pixel defects/faults""meet the pre-defined criteria"
    Miscellaneous ArtifactsAbsence of artifacts as specified in TG18 guideline"meet the pre-defined criteria"
    Temporal ResponseMeet pre-defined criteria"meet the pre-defined criteria"
    LuminanceMeet pre-defined criteria"meet the pre-defined criteria"
    Conformance to DICOM GSDFConformance as specified in AAPM TG18 guideline"meet the pre-defined criteria"
    Color TrackingMeet pre-defined criteria"meet the pre-defined criteria"

    Additional Information based on the provided document:

    1. Sample Size Used for the Test Set and Data Provenance:

      • Sample Size: Not applicable in the context of this device. The performance testing was conducted on the device itself (RadiForce RX360), not on a set of patient data.
      • Data Provenance: Not applicable. The tests were bench tests performed on the display device following FDA guidance.

    2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

      • Not applicable. This device is a display monitor, and its performance tests do not involve establishing ground truth from expert readings of medical images. The tests measure technical display characteristics.

    3. Adjudication Method for the Test Set:

      • Not applicable. As above, this document describes technical performance testing of a display monitor, not a diagnostic algorithm.

    4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

      • No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No animal or clinical testing was performed on the RadiForce RX360."

    5. Standalone Performance (Algorithm only without human-in-the-loop performance):

      • Not applicable. This is not an AI algorithm. Its performance refers to its technical specifications as a display device.

    6. Type of Ground Truth Used:

      • Not applicable. The "ground truth" for this device would be the established technical standards and specifications (e.g., DICOM GSDF, AAPM TG18 guidelines) against which the display's performance is measured. It's not clinical "ground truth" like pathology or outcomes data.

    7. Sample Size for the Training Set:

      • Not applicable. This is not an AI device trained on data.

    8. How the Ground Truth for the Training Set was Established:

      • Not applicable.

    In summary, the provided document describes the regulatory submission for a medical display monitor and its technical performance validation, not an AI medical device.

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