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Proceedings Paper

A case study regarding clinical performance evaluation method of medical device software for approval
Author(s): Koji Shimizu; Gakuto Aoyama; Mizuho Nishio; Masahiro Yakami; Takeshi Kubo; Yutaka Emoto; Tatsuya Ito; Tomohiro Kuroda; Hiroyoshi Isoda
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Paper Abstract

We have developed a novel medical device software program that is intended to improve radiologists’ performance with regard to the detection of bone metastases on CT images. To establish the protocol of the clinical performance evaluation for regulatory approval, the feasibility of nonclinical study (NCS) and clinical study (CS) conforming to the principles of GCP was compared. There were two main issues with establishing the protocol in Japan. Firstly, retrospective case collection was not accepted for CS due to concerns regarding selection bias. However, it is difficult to prospectively collect cases for use in an observer study due to the wide variety of bone metastases cases required. Secondly, when setting the reference standard (RS) for bone metastases, the utilization of any patient information was not accepted for NCS due to concerns regarding an inappropriate RS setting. However, it was predicted that it would be difficult to set accurate RSs only using CT images. Consequently, following discussion with a Japanese regulatory body, the protocol was established as an NCS using retrospectively collected CT images. Furthermore, we agreed to use anonymized clinical images to set the RS and to rescue the test results by reviewing the RS after the observer study, hence ensuring reliability. An NCS was a feasible method of evaluating the novel medical device software while also complying with quality management systems. By using real-world clinical image databases, this clinical performance evaluation method may be both effective and efficient as a path to regulatory approval of certain medical device software.

Paper Details

Date Published: 4 March 2019
PDF: 7 pages
Proc. SPIE 10952, Medical Imaging 2019: Image Perception, Observer Performance, and Technology Assessment, 1095210 (4 March 2019); doi: 10.1117/12.2511936
Show Author Affiliations
Koji Shimizu, Kyoto Univ. Hospital (Japan)
Gakuto Aoyama, Canon Inc. (Japan)
Mizuho Nishio, Kyoto Univ. Hospital (Japan)
Masahiro Yakami, Kyoto Univ. Hospital (Japan)
Takeshi Kubo, Kyoto Univ. Hospital (Japan)
Yutaka Emoto, Kyoto College of Medical Science (Japan)
Tatsuya Ito, Kyoto Univ. Hospital (Japan)
Tomohiro Kuroda, Kyoto Univ. Hospital (Japan)
Hiroyoshi Isoda, Kyoto Univ. Hospital (Japan)

Published in SPIE Proceedings Vol. 10952:
Medical Imaging 2019: Image Perception, Observer Performance, and Technology Assessment
Robert M. Nishikawa; Frank W. Samuelson, Editor(s)

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