ECG-AI LEF 12-Lead Algorithm

The Low Ejection Fraction AI-ECG Algorithm (v.2.2.0 (1010)) interprets 12-lead ECG voltage times series data using an artificial intelligence-based algorithm. The device analyzes 10 seconds of a single 12-lead ECG acquisition, and within seconds provides a prediction of likelihood of LVEF (ejection fraction less than or equal to 40%) to third party software. The results are displayed by the thirdparty software on a device such as a smartphone, tablet, or PC. The Low Ejection Fraction AIECG Algorithm was trained to predict Low LVEF using positive and control cohorts, and the prediction of Low LVEF in patients is generated using defined conditions and covariates.The Low Ejection Fraction AI-ECG Algorithm device is intended to address the unmet need for a point-of-care screen for LVEF less than or equal to 40% and is expected to be used by cardiologists, front-line clinicians at primary care, urgent care, and emergency care settings, where cardiac imaging may not be available or may be difficult or unreliable for clinicians to operate. Clinicians will use the Low Ejection Fraction AI-ECG Algorithm to aid in screening for LVEF less than or equal to 40% and making a decision for further cardiac evaluation.