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    K Number
    K241038
    Device Name
    Cardiac CT Function Software Application
    Manufacturer
    Circle Cardiovascular Imaging
    Date Cleared
    2024-06-07

    (52 days)

    Product Code
    QIH,LLZ,OIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K141302
    Why did this record match?
    Device Name :

    Cardiac CT Function Software Application

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

    The Cardiac CT Function Software Application is indicated to be used with multi-phase, multi-slice cardiovascular CT angiography images to assist qualified medical professionals in assessing and evaluating cardiac function. CT Function includes manual and semi-automatic heart segmentation of 2 chambers (LV and RV) and calculation of cardiac function metrics including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, and LV myocardial mass.

    Device Description

    Circle's Cardiac CT Function Software Application ("CT Function Module" or "CT Function", for short) is a software device that enables the analysis of cardiac images acquired using computed tomography (CT) scanners. It is designed to support physicians in the visualization, and analysis of heart function through the calculation of parameters such as volume and mass. The device is intended to be used as an aid to the existing standard of care and does not replace existing software applications that physicians use. The CT Function Module does not interface directly with any data collection equipment, and its functionality is dependent on the type of vendor acquisition equipment. The analysis results are available on-screen or can be saved for future review.

    CT Function consists of multiplanar reconstruction (MPR) views and 3D rendering of the original CT data. The module displays three MPR views that the user can freely adjust to any position and orientation. Lines and regions of interest (ROIs) can be manually drawn on these MPR images for quantitative measurements.

    The CT Function Module implements an Artificial Intelligence / Machine Learning (AI/ML) algorithm to detect and segment heart structures and post-processing methods to convert the heart segments to editable surfaces. All surfaces generated by the system are editable and users are advised to verify and correct any errors; if desired, users can also perform seqmentation of the cardiac structures manually using surface contour generation tools.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the Cardiac CT Function Software Application, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    MetricRegionAcceptance Criteria (Implied from "less than X%" or "above Y%")Reported Device Performance
    Mean Absolute Error (MAE) for Volume PredictionLV Cavity86%> 86%
    3D Hausdorff Distance (HD)LV Cavity85%> 85%
    3D Hausdorff Distance (HD)RV Cavity82%> 82%
    3D Hausdorff Distance (HD)LV Myocardium
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