Table 1.

Comparison of the consensus and the study protocol in BP measurement.

	Consensus protocol	Study protocol
Validation sample size	At least 85 subjects. In case an independent general population of 85 subject studies has been completed successfully, a compromise was agreed to accept a minimum of 35 special population subjects.	35 subjects in the acute ischemic stroke population.
Cuff size-stratified subgroups	A minimum of 22 subjects per cuff, which means, that 4 cuffs could be evaluated in an 88-subject study.	Not applicable in the watch device.
Reference blood pressure measurement and validation procedure	Same arm sequential measurement. Four reference BP measurements. follow, alternated by 3 test device measurements (R1–T1–R2–T2–R3–T3–R4). Measurements will be performed with at least 60-second intervals.	Same arm sequential measurement with 2 arms performed simultaneously. Divided into 2 arms, first reference BP measurements and device calibration, followed by 2 reference BP measured simultaneously with 2 test devices. Measurement performed with 60-second intervals.
Validation criteria	BP difference meets both criteria 1 and 2. Presented with Bland–Altman scatterplots.	BP difference meets both criteria 1 and 2. Presented with Bland–Altman scatterplots.