ppt课件-统计得失数字病理学（ statistical issuesfor digital pathology）.pptVIP

Statistical Considerations in the Evaluation of Digital Pathology Devices Hematology and Pathology Devices Panel Meeting October 22-23, 2009 Shanti Gomatam, Ph.D. Mathematical Statistician FDA/CDRH/OSB/DBS Outline Intended Use Clinical Study Design Issues Study Design Examples Assessing Results Precision Studies Intended Use The intended use under discussion is for primary diagnosis of surgical pathology microscope slides in lieu of an optical microscopy (OM). Broad application -- not organ or disease specific. The Intended Use Population (IUP) is the population of subjects on whom the dev