perform the following studies to evaluate the medical devices
1.qualitative parameters
a. Sensitivity and specificity
b. comparison study
c. conduct C50 analysis for qualitative precision
2.quantitative parameters
a. precision study
b. trueness study
c. comparison study
d. linearity study
e. reportable range study based on provided population
f. Uncertainty provided that cumulative data for the past 6 months should be available
the analysis conducted using Excel, SPSS, origin lab