Us2.v2 is software that processes cardiac ultrasound images to automatically measure various heart structures and functions, helping clinicians analyze echocardiograms more efficiently and accurately. It supports qualified healthcare professionals by providing automated measurements of cardiac size and function, improving workflow and aiding diagnosis in adult patients.
Intended Use
Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients.
Technology
Us2.v2 is an image post-processing analysis software that provides automatic, reproducible quantitative echocardiographic measurements from DICOM-format cardiovascular ultrasound images, using machine learning-based view classification and border detection. It automates measurements of cardiac dimensions and left ventricular function from multiple ultrasound modalities (B mode, M mode, Doppler), integrating guideline-based reference values and offers editable markup for clinical use.
Performance
The device was developed per design control processes and underwent extensive verification and validation, including unit, module, and integration testing. Clinical validation compared automated measurements versus expert human measurements using separate datasets from distinct cohorts. Metrics such as Root Mean Square Error (RMSE) and Intraclass Correlation Coefficient (ICC) demonstrated performance parity, with testing conducted on data from 8 ultrasound device vendors and US-based patient populations.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/16/2023
4 months - 2
FDA Approval
4/1/2024
Other devices from Eko.ai Pte. Ltd d/b/a Us2.ai
- Us2.v12021 • 510K
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