IEEE Std 1708a-2019 pdf download – IEEE Standard for Wearable, Cuffless Blood Pressure Measuring Devices.
4.3 Subject selection Insert new 4.3.1 heading before text in 4.3 and change text as follows: 4.3.1 Subject selection requirements for normal adult population The summarized requirements on subject selection are presented in Table 1. Forty five At least eighty-five (85) subjects, with at least 22 26 females and 22 4226 males, aged between 1821 years and 6550 years old shall be recruited if the device is intended for adult use. The study participants are to be introduced to the observers, who will explain to them the eligibility requirements and specific procedures. Initials, sex, date of birth, medical history and current medications are to be recorded on the case report form. Pregnant, pediatric, or elderly people, or those with present arrhythmias, should not be included in the study. If a wearable. cuffless BP measuring device’s intended use is not limited to the population described by the subject sclection requirements in 4.3.1. additional performance evaluation shall be conducted according to 4.3.3. The intended use population is determined by reviewing the instructions for use. The subjects shall also have a specified range of BP. The endpoint of the BP classification is determined according to the JNC 7 report [B5]. The BP used in the analysis should be the entry BP measured by a trained observer following the recommendation called out by BHS protocol [B21]. Three measurements are required at the sitting position, and the averaged value is used as the entry BP to determine the subject’s BP classification. If a wearable, cuffless BP measuring device uses patient-specific parameters (height, weight, sex, age. etc.) in the calculation of BP. each patient-specific parameter used in the calculation should be recorded in the case report form. The range of each parameter from the study participants should cover the expected population during device use.
The validation may proceed to Phase 2 only if the test device passes accuracy criteria in Phase 1 (see 4.5.2); if not, the device should be eliminated from further testing. Correlation between errors in measurements from the same subject is considered after Phase 1 to determine if additional subjects (more than 65) may be needed in Phase 2, see 4.5.3. Two test devices should be randomly chosen from the device pool. Those two devices should be used through the whole validation procedure with each device completing validation on at least 22 42 subjects.