Changes in software as a medical device based on artificial intelligence technologies.
Artificial intelligence
Changes
Medical software based on artificial intelligence technologies
Modifications
Software as a medical device
Validation
Journal
International journal of computer assisted radiology and surgery
ISSN: 1861-6429
Titre abrégé: Int J Comput Assist Radiol Surg
Pays: Germany
ID NLM: 101499225
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
received:
06
12
2021
accepted:
30
04
2022
pubmed:
13
6
2022
medline:
15
9
2022
entrez:
12
6
2022
Statut:
ppublish
Résumé
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. 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. 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. 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.
Identifiants
pubmed: 35691995
doi: 10.1007/s11548-022-02669-1
pii: 10.1007/s11548-022-02669-1
pmc: PMC9188918
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1969-1977Subventions
Organisme : The Program of the Moscow Healthcare Department "Scientific Support of the Capital's Healthcare" for 2020-2022
ID : No. in the Unified State Information System for Accounting of Research, Development, and Technological Works (EGISU): AAAA-A21- 121012290079-2)
Informations de copyright
© 2022. CARS.
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