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EchoGo Pro v1.0.2 is a machine learning-based decision support system, indicated as an adjunct to diagnotic stress echocardiography for patients undergoing assessment for coronary artery disease (CAD). When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis. Patient management decisions should not be made solely on the results of the EchoGo Pro v 1.0.2 analysis. EchoGo Pro v 1.0.2 is to be used with stress echo exam protocols that contain A2C, A4C and mid-ventricular short-axis views at rest and at peak stress. EchoGo Pro v1.0.2 is not intended for the assessment of mild or moderate myocardial ischemia, or localization of coronary artery disease, or for the assessment of myocardial perfusion, myocardial viability or valve disease.

EchoGo Pro v1.0.2 is a standalone software application that utilizes anonymized DICOM 3.0 compliant stress echo (SE) datasets to provide a categorical assessment as to whether the data are suggestive of a higher or lower possibility of significant CAD. The software automatically registers images, and segments and analyses selected regions of interest (ROI). EchoGo Pro v1.0.2 utilizes standard clinical SE protocols that provide apical 2 chamber and parasternal short axis (SAX) views. Ultrasound images are acquired from a third-party acquisition device. The incoming DICOM study is checked for consistency and completeness, i.e. whether all required views labels are present in metadata. Once the technical QC has been performed on the DICOM datasets, the algorithm for automated contour detection of the endocardium of the LV is applied and presented for review and approval by trained Operators. An auto-contouring algorithm places a trace around the LV that sufficiently captures the LV shape. Outlining is detected for all frames in between and including end-systole (ES) and end-diastole (ED) for AP2, AP4, and mid-ventricular short axis (SAX) views of the LV at both rest and peak stress. Trained operators review and approve of the contour traces. The approved contour traces are used in calculations for geometric parameters. Geometric parameters are calculated from the approved contours and are fed into a fixed classification model that has been previously trained on datasets with known outcomes. The output of the pre-trained model generates a report which contains a categorical assessment as to whether the data are consistent with significant CAD or not. Significant CAD as determined by EchoGo Pro, based on LV segmentation (ROI) analysis, and was defined as ≥70% stenosis in the proximal to mid LAD, proximal left circumflex or proximal to mid RCA as measured by invasive angiography performed within 6 months of stress echocardiogram.

EchoGo Core is intended to be used for quantification and reporting of cardiovascular function to support physician diagnosis. EchoGo Core is indicated for use in adult populations.

EchoGo Core is a standalone software application that automatically measures standard cardiac parameters including Ejection Fraction (EF), Global Longitudinal Strain (GLS), and Left Ventricular (LV) volume. EchoGo Core provides a service to calculate those values and provide a report back to the clinician. EchoGo Core analyzes echocardiogram cardiac parameters. An echocardiogram is performed using standard echocardiograms protocols. The anonymized echocardiogram dataset is transferred to Ultromics and once received the images are processed through the application's workflow. Once the technical QC has been performed, the automated contour detection of the endocardium of the LV is reviewed and approved by trained operators. Identifying and outlining the LV is standard practice in echocardiography and present in many other cleared devices, including the predicate device TomTec Arena TTA2 (K150122). In the proposed device, an auto-contouring algorithm places points around the LV that sufficiently capture the LV shape. These contours are used in calculations for geometric parameters. As with the TomTec Arena TTA2, the following parameters are calculated for inclusion in the report: EF: calculated from Simpson's Biplane Method (SBM) LV Volumes. GLSAVG: standard calculations, averaged from 2 chamber and 4 chamber views. LV volume: SBM calculated left ventricular volumes. A worksheet is automatically generated from the calculated parameters which is returned to the interpreting clinician. This report is intended as an additional input to standard diagnostic pathways and is only to be used by qualified clinicians.