Challenges in digital pathology and its recent development
*Yuying Jin, FDA/CDRH  Meijuan Li, US Food and Drug Administration 

Keywords: Digital Pathology, Reader Variabiltiy, Models

Advancement in computer technology enables the improved management of image-based information from a digital pathology slide. The digital pathology converts glass slides into digital slides whose pattern can be recognized, searched and analyzed on a computer monitor. There are several challenges in evaluating such device. Reader is often a large source of variability for device of digital pathology. How to assess it appropriately is one of the challenges, in particular models selected for the study that assess reader variability may have an impact on the results of reader variability, as well as other sources of variability included in the study. In addition, the proposed device may have very different technology from the existing device, how to evaluate the performance in a meaningful way is not straightforward. In this presentation, statistical considerations on the study design and analyses will be discussed based on our experience and current thinking.