Figure 1.

(a) Study design for analytical validation of an algorithm (stand-alone performance assessment). Algorithm outputs are compared to the reference standard. (b) Independent crossover study design for clinical validation has two arms corresponding to pathologist evaluations without and with the algorithm. We compare the performance of these two evaluation modes. (c) Sequential study design for clinical validation has one arm corresponding to end user evaluations first without and then with the algorithm as an aid. A comparison is made between the performance of these two evaluation modes