A representative data from a single-center, non-randomized, prospective study conducted by a medical device company to demonstrate equivalency in performance between a FDA-cleared oxymetry system and an investigational system. Thirty-two healthy, non-smoking (or has refrained from smoking for 2 days) adults and adolescent volunteers, ages 18 to 50 years olds, have been recruited. Multiple measures of paired difference of tissue oxygen saturation levels have been obtained for each subject. Due to the proprietary nature of the data, we simulated a representative data with 20 subjects to mimic the original data set based on estimated model from the original data.
A dataframe with two components
differences of repeatedly measured oxygen levels between a FDA-clearted oxymetry and an investigational oxymetry system.
individual ids (coded as 1 to 20)
Bai,Y., Wang,Z., Lystig,T.C., and Wu,B. (2019) Statistical test with sample size and power calculation for paired repeated measures designs of method comparison studies. bioRxiv, 516658.
Bai,X., Bai,Y. and Wu,B. (2019) Generalized confidence interval calculation for the total variance in a single-factor random-effects ANOVA model with application to medical device comparison problems. tech report.
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