A case study regarding clinical performance evaluation method of medical device software for approval

Koji Shimizu, Gakuto Aoyama, Mizuho Nishio, Masahiro Yakami, Takeshi Kubo, Yutaka Emoto, Tatsuya Ito, Tomohiro Kuroda, Hiroyoshi Isoda. A case study regarding clinical performance evaluation method of medical device software for approval. In Robert M. Nishikawa, Frank W. Samuelson, editors, Medical Imaging 2019: Image Perception, Observer Performance, and Technology Assessment, San Diego, California, United States, 16-21 February 2019. Volume 10952 of SPIE Proceedings, pages 1095210, SPIE, 2019. [doi]

Abstract

Abstract is missing.