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510(k) Data Aggregation

    K Number
    K213891
    Device Name
    RealNow
    Manufacturer
    YIWEI Medical Technology Co., Ltd
    Date Cleared
    2023-02-24

    (437 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K121447
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    RealNow is an image processing software package to be used by trained professionals including physicians. The software runs on a standard "off-the-shelt" computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, analysis and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM compliant imaging devices.

    RealNow provides viewing, analysis and communication capabilities for functional and dynamic imaging datasets that are acquired with CT Perfusion imaging protocols.

    Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated in the standard DICOM format and may be viewed on existing radiological imaging viewers.

    Device Description

    RealNow image analysis includes calculation of the following perfusion related parameters:

    • Cerebral Blood Flow (CBF)
    • Cerebral Blood Volume (CBV)
    • Mean Transit Time (MTT)
    • Residue function time-to-peak (TMax)
    • Arterial Input Function (AIF)

    The primary users of RealNow are medical imaging professionals who analyze dynamic CT perfusion studies. The results of image analysis produced by RealNow should be viewed through appropriate diagnostic viewers when used in clinical decision making.

    AI/ML Overview

    The RealNow device is an image processing software package for CT perfusion scans of the brain. The acceptance criteria and the study proving the device meets these criteria are detailed below. The study's "ground truth" for non-clinical testing was the output of a legally marketed predicate device, RAPID (K121447).

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for RealNow were established by comparing its output to the RAPID predicate device. The performance was assessed through pixel-by-pixel comparison and volumetric analysis.

    Acceptance Criterion (for each scan)Reported Device Performance
    Intraclass Correlation Coefficient (ICC) > 0.75 for all voxels within the brain tissue for parametric maps.CBF, CBV, MTT, Tmax Parameter Maps: All proportion of acceptable maps (ICC > 0.75) were > 90% (p=0.0009 for CBF and CBV, p=0.0196 for MTT and Tmax). Specific ICC values are not provided, only the proportion of maps meeting the threshold.
    Assessment of bias for volumetric comparison (e.g., CBF
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