Search Results

Us2.v1 is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracy cardiac ultrasound images, automatically producing a full report with measurements of several and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists or licensed primary care providers for clinical decision-making. Us2.v1 is in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, pericardial disease, and/or intra-cardiac lesions (e.g. tumours, thrombi).

Us2.v1 is an image post-processing analysis software device used for viewing and quantifying cardiovascular ultrasound images in DICOM format. The device is intended to aid diagnostic review and analysis of echocardiographic data, patient record management and reporting.

The software provides an interface for a skilled sonographer to perform the necessary markup on the echocardiographic image prior to review by the prescribing physician. The markup includes: the cardiac segments captured, measurements of distance, time, area and blood flow, quantitative analysis of cardiac function, and a summary report.

The software allows the sonographer to enter their markup manually. It also provides automated markup and analysis, which the sonographer may choose to accept outright, to accept partially and modify, or to reject and ignore. Machine learning based view classification and border detection form the basis for this automated analysis. Additionally, the software has features for organizing, displaying and comparing to reference guidelines the quantitative data from cardiovascular images acquired from ultrasound scanners.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The documents state a single, overarching acceptance criterion:

Ask a specific question about this device