Study participants
obesity, diabetes, cardiovascular disease, Raynaud’s disease
OBESITY, PULMONARY DISEASE, CLOTTING DISORDERS, SYSTEMIC ILLNESS
Twenty-eight healthy adult (≥ 18 to < 50 years) volunteer subjects were enrolled. Inclusion criteria were good general health, non-smokers, and normal hemoglobin (≥ 10 g/dL). Exclusion criteria were obesity, serious systemic illness, diabetes, cardiovascular disease, pulmonary disease, Raynaud’s disease, clotting disorders, and pregnant or lactating females. Subject enrollment was designed to meet FDA guidance requirements of a minimum of two darkly pigmented subjects or 15% of the total pool, whichever is larger [Half of the subjects (N = 14) were randomly assigned to the motion protocol and the other half (N = 14) were randomly assigned to the low perfusion protocol. A minimum threshold of measurement pairs was included in accordance with ISO 80601-2-61:2017. The 14-subject sample size for each protocol meets FDA requirements [FDA] for the study and is consistent with other published analyses of similar technologies [