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This study focused on the statistical aspect of establishing standard to assess the accuracy of cuff-less BP measuring devices. The results of our study on the validation reports of various cuff-based devices and an experimental study on a cuff-less device showed that the t4 distribution is better than the normal distribution in portraying the underlying error distribution of both kinds of devices. Moreover, based on both the theoretical and experimental studies, mean absolute difference or mean absolute percentage difference is recommended as continuous scale to assess the accuracy of cuff-less devices for their own distinctive advantages.

This paper proposes one of the unique requirements in the validation protocol of the IEEE P1708 standard in assessing wearable cuff-less blood pressure (BP) measuring devices. Based on principles that are different from that of the conventional cuff-based devices, the cuff-less BP measurement approaches often require an individual calibration procedure. In this study, we used data from an experiment carried out on 28 subjects with a total of 139 sets of BP measurements as an example to show that breakdown of the performance evaluation of cuff-less devices according to the change of BP from the point of calibration is crucial for understanding and interpreting the overall accuracy of the device.

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