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. 2022 Oct;17(10):1969-1977.
doi: 10.1007/s11548-022-02669-1. Epub 2022 Jun 13.

Changes in software as a medical device based on artificial intelligence technologies

Victoria Zinchenko  1 , Sergey Chetverikov  2 , Ekaterina Akhmad  3 , Kirill Arzamasov  2 , Anton Vladzymyrskyy  4 , Anna Andreychenko  5   2 , Sergey Morozov  6
Affiliations

Changes in software as a medical device based on artificial intelligence technologies

Victoria Zinchenko et al. Int J Comput Assist Radiol Surg. 2022 Oct.

Abstract

Purpose: to develop a procedure for registering changes, notifying users about changes made, unifying software as a medical device based on artificial intelligence technologies (SaMD-AI) changes, as well as requirements for testing and inspections-quality control before and after making changes.

Methods: The main types of changes, divided into two groups-major and minor. Major changes imply a subsequent change of a SaMD-AI version to improve efficiency and safety, to change the functionality, and to ensure the processing of new data types. Minor changes imply those that SaMD-AI developers can make due to errors in the program code. Three types of SaMD-AI testings are proposed to use: functional testing, calibration testing or control, and technical testing.

Results: The presented approaches for validation SaMD-AI changes were introduced. The unified requirements for the request for changes and forms of their submission made this procedure understandable for SaMD-AI developers, and also adjusted the workload for the Experiment experts who checked all the changes made to SaMD-AI.

Conclusion: This article discusses the need to control changes in the module of SaMD-AI, as innovative products influencing medical decision making. It justifies the need to control a module operation of SaMD-AI after making changes. To streamline and optimize the necessary and sufficient control procedures, a systematization of possible changes in SaMD-AI and testing methods was carried out.

Keywords: Artificial intelligence; Changes; Medical software based on artificial intelligence technologies; Modifications; Software as a medical device; Validation.

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Conflict of interest statement

The authors declare they have no financial interests. Morozov S.P. was an unpaid president European Society of Medical Imaging Informatics (till 2018). Morozov S.P. is an unpaid chairman of SC 01 “Artificial Intelligence in Healthcare”.

Figures

Fig. 1
Fig. 1
Variants of SaMD-AI changes
Fig. 2
Fig. 2
SaMD-AI No.1 operation results after making a change. Errors – localization of pathology outside the organ of interest – the lungs (a, b)
Fig. 3
Fig. 3
SaMD-AI No.2 operation results before making changes (a) and after (b)
Fig. 4
Fig. 4
SaMD-AI operation results No.3: a defects in the first version of SaMD-AI No.3 – localization of pathology on the heart, spine, abdominal organs; b after making the second changes – areas without pathological changes are localized, labeling outside the target organ
Fig. 5
Fig. 5
“Changes in SaMD-AI efficiency and safety”
Fig. 6
Fig. 6
“Changes related to input data without changes in the functional purpose of the SaMD-AI”
Fig. 7
Fig. 7
“Changes in the functional purpose of the SaMD-AI”
Fig. 8
Fig. 8
“Changes related to the elimination of errors and program code modifications of the SaMD-AI”
See this image and copyright information in PMC

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