Evaluating Quality and Utility of Digital Mammograms and Lossy Compressed Digital Mammograms

... This paper is a summary of principles for the design of clinical experiments to quantify quality and utility of medical images along with preliminary results of a pilot experiment. It has evolved as a result of cooperative research among engineers, statisticians, radiologists, and medical physicists. The protocol and experiment provide a context for discussion of a "strawman" experimental design for approval of digital mammography devices promoted by the Center for Devices and Radiological Health of the Federal Drug Administration (CDRH/FDA)