Reliability analysis and clinical validation of smart portable ECG devices for home patient cardiac care

Abstract This research paper presents a detailed reliability analysis and validation of a smartphone-based Electrocardiogram (ECG) acquisition device (Spandan) for prior-cardiac disorder detection for home patients. Numerous IoT-based wearable medical devices for continuous cardiovascular signal monitoring are available; however, conducting validation and reliability analyses of these medical devices is crucial to ensure their effectiveness. The study includes 28 normal and abnormal participants for the investigation of the Spandan ECG device. It aims to validate and assess the reliability of the Spandan ECG device with respect to the RMS Vesta 301i ECG device (standard 12-lead ECG device). So, this study compares the time interval of the ECG parameters of the Spandan ECG device with the RMS Vesta 301i ECG device. The statistical analysis reveals that the Spandan ECG device achieves an overall accuracy of 95.3% with respect to the RMS Vesta 301i ECG device. The investigation of the reliability of the Spandan devices is assessed using Bland-Altman limits of agreement, Intra-class correlation coefficient (ICC), Paired t-tests, Repeatability test, and Pearson coefficient. The ICC is evaluated with a high value of 0.9957 (99.57%), demonstrating the excellent reliability of Spandan ECG devices. The obtained p-value is 0.0001, which signifies a substantial degree of agreement between Spandan and the RMS Vesta 301i ECG device.