RE: Talk about this instead29 Jul 2021 11:08
TBF it does seems we need a larger sample size or am I reading it wrong....
Sample size of clinical positive samples Please attach and highlight relevant reference in IFU and publications Automatic reject if <100 Minimal acceptable number is 100, desired number is greater than or equal to 150
Sample size for negative clinical samples) Please attach and highlight relevant reference in IFU and publications Automatic reject is <150 Minimal acceptable number is 150, desired number is 250