Key result
The Spandan 12-lead smartphone ECG device achieved 95.3% overall accuracy and an intraclass correlation coefficient of 0.9957 (p=0.0001) compared to the standard RMS Vesta 301i 12-lead ECG device.
Why the study?
Although numerous IoT-based wearable medical devices for continuous cardiovascular signal monitoring are available, validation and reliability analyses are needed to ensure the effectiveness of the smartphone-based Spandan ECG device for home patients.
Does the Spandan 12-lead smartphone-based portable ECG device provide accurate and reliable ECG interval measurements (PR, QRS, QT, QTc) compared to a standard 12-lead RMS Vesta 301i ECG device in adult patients?
Observational (n=28)
No
Does the Spandan 12-lead smartphone-based portable ECG device provide accurate and reliable ECG interval measurements (PR, QRS, QT, QTc) compared to a standard 12-lead RMS Vesta 301i ECG device in adult patients?
This clinical validation study demonstrates that the portable smartphone-based Spandan 12-lead ECG device achieves 95.3% accuracy and high reliability (ICC 0.9957) in measuring standard ECG intervals (PR, QRS, QT, QTc) compared to a conventional 12-lead ECG machine, supporting its utility for home cardiac monitoring.
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May support portable ECG monitoring in select settings; leaves open larger prospective validation before clinical adoption.
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.
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Patel et al. (2026) conducted an observational in Normal and abnormal cardiac conditions (17 normal, 11 abnormal) (n=28). Spandan 4.0 12-lead smartphone-based portable ECG device vs. RMS Vesta 301i standard 12-lead ECG device was evaluated on Overall accuracy and reliability (Intraclass Correlation Coefficient [ICC]) of ECG time interval parameters (PR, QRS, QT, QTc) (ICC 0.9957 (overall accuracy 95.3%), p=0.0001). The Spandan 12-lead smartphone ECG device achieved 95.3% overall accuracy and an intraclass correlation coefficient of 0.9957 (p=0.0001) compared to the standard RMS Vesta 301i 12-lead ECG device.
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