Validation Study of a Derived 12 Lead Reconstructed ECG Interpretation in a Smartphone-Based ECG Device

For the detection of focal Ischemia and transient intermittent episode of arrhythmia, 12 lead ST-segment monitoring is widely used. The 12 lead ECG consists of 3 Limb leads, 3 Augmented leads, and 6 Precordial Leads. The Increase of Portable ECG machines in the Indian and International markets has led to uncertainty for the Accuracy related queries and confusion regarding the reliability and age of accessibility of these medical devices. In this study, we have clinically validated the Interpretation capabilities of a portable smartphone-based ECG device. A total of 202 subjects were tested with sequential 12 lead ECG machine. The trials were conducted for 112 days in an observational setup. Each 12 lead ECG test took an average time of 1 min and 30 s. The Clinical Interpretation of the ST-Elevation and Arrhythmias via. the gold standard ECG machines present in the hospital are compared with Smartphone-based 12 lead Data for computer Interpretation of the reconstructed ECG reports. This study aims to evaluate the sensitivity, specificity, Negative Predictive Value, and Positive Predictive Value of the tests taken in various subjects.