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

doi:10.1117/12.2511936

4 March 2019 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

Author Affiliations +

Proceedings Volume 10952, Medical Imaging 2019: Image Perception, Observer Performance, and Technology Assessment; 1095210 (2019) https://doi.org/10.1117/12.2511936
Event: SPIE Medical Imaging, 2019, San Diego, California, United States

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.

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Koji Shimizu, Gakuto Aoyama, Mizuho Nishio, Masahiro Yakami, Takeshi Kubo, Yutaka Emoto, Tatsuya Ito, Tomohiro Kuroda, and Hiroyoshi Isoda "A case study regarding clinical performance evaluation method of medical device software for approval", Proc. SPIE 10952, Medical Imaging 2019: Image Perception, Observer Performance, and Technology Assessment, 1095210 (4 March 2019); https://doi.org/10.1117/12.2511936

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KEYWORDS

Computed tomography

Bone

Medical devices

Diagnostics

Clinical trials

Medical research

Medical device development

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