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

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. Meth...

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Bibliographic Details
Published in:International journal for computer assisted radiology and surgery 2022, Vol.17 (10), p.1969-1977
Main Authors: Zinchenko, Victoria, Chetverikov, Sergey, Akhmad, Ekaterina, Arzamasov, Kirill, Vladzymyrskyy, Anton, Andreychenko, Anna, Morozov, Sergey
Format: Article
Language:English
Subjects:
Artificial intelligence
Computer Imaging
Computer Science
Decision making
Functional testing
Health Informatics
Imaging
Medical equipment
Medicine
Medicine & Public Health
Modules
Pattern Recognition and Graphics
Quality control
Radiology
Short Communication
Software
Surgery
Vision
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Summary: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.
ISSN:1861-6429
1861-6410
1861-6429
DOI:10.1007/s11548-022-02669-1