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    K Number
    K223422
    Device Name
    Emory Cardiac Toolbox 4.3
    Manufacturer
    Syntermed
    Date Cleared
    2023-03-30

    (136 days)

    Product Code
    KPS,JAK,LLZ
    Regulation Number
    892.1200
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K201034,K123646,K201632
    Why did this record match?
    Device Name :

    Emory Cardiac Toolbox 4.3

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

    The Emory Cardiac Toolbox™ 4.0 – 4.3 software program should be used for the quantification of myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from SPECT & PET myocardial perfusion studies (EGS™) including to quantitatively evaluate the wall motion and wall thickening of the heart using longitudinal, radial, and circumferential strain measurements, for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and analysis of the CT data to evaluate calcified plaques in the coronary arteries, for the assessment of cardiac mechanical dyssynchrony using phase analysis, for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered back projection (FBP) or iterative reconstruction (MLEM/OSEM), for the quantification of myocardial blood flow and coronary flow reserve, and for the decision support in interpretation (LVX) and automatic structured reporting of the study.

    Device Description

    The Emory Cardiac Toolbox™ 4.3 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies.

    AI/ML Overview

    The Emory Cardiac Toolbox™ 4.3 device's performance validation is described in section 8 of the provided document. The device includes two main new features: Emory-CACS for calcium plaque evaluation and ECTb™ Strain for wall motion and thickening analysis using strain measurements.

    Here's a breakdown of the acceptance criteria and study details for each feature:

    1. Table of acceptance criteria and reported device performance:

    FeatureAcceptance Criteria (Proxy)Reported Device Performance
    Emory-CACSHigh correlation with the predicate device (Siemens SyngoVia™ toolbox) for both plaque volume and Agatston score. (Implied: r² > 0.99 for both based on predicate's performance)Plaque Volume: Linear regression (m = 1.10; b = 0.46) produced an r² = 0.99.
    Agatston Score: Linear regression (m = 1.01; b = 1.06) produced an r² > 0.99.
    "The values obtained by the Emory-CACS module demonstrated excellent correlations with the Syngo.CT CaScoring developed by Siemens Medical Solutions."
    ECTb™ Strain AnalysisEstablish normal limits for longitudinal, radial, and circumferential strains from a low-risk cohort. Demonstrate strong correlation between PET MPI and TTE for longitudinal, radial, and circumferential strains at both stress and rest in a CAD cohort. (Implied: r > 0.5 for all correlations based on predicate's performance or clinical significance)Normal Limits: Established using a low-risk cohort (n=22), defined as mean radial strain - 2SD, and mean circumferential/longitudinal strain + 2SD.
    Correlation (CAD Cohort, n=80):
    Longitudinal Strain: Stress (r=0.68, p
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