Purpose or Learning Objective: The aim of this study was to analyse potential discrepancies between the claims and disclaimers of the intended purpose statements of CE-marked AI-based software for radiology.
Methods or Background: In March 2022, we asked all vendors listed on www.AIforRadiology.com (n=87) to verify or submit the intended purpose according to European clearance for their products (n=191). Any new additions were included until September 26th 2022 (n=12)). Claims and disclaimers were extracted from the statements. Potential conflicts of claims and disclaimers were flagged.
Results or Findings: We received the intended purpose statements for 157 of the 203 products. Of those, 36 were excluded as they provided too little information to analyse. The included products were certified under the current medical device regulations (class IIa = 24, class IIb = 9) and former Medical Device Directive (class I = 45, class IIa = 39, class IIb = 3). Of the 121 included statements 56 held disclaimers. For 13 of these products the claims and disclaimers were flagged to contradict each other. Potential discrepant disclaimer statements were e.g. 'act per the standard of care' (n=7) and 'not for diagnostic use' (n=6), while claiming to aid in the diagnosis, triaging or risk scoring of clinical conditions.
Conclusion: Potential discrepancies in claims and disclaimers were found for a substantial number of AI-tools bearing the risk that users of the AI software misunderstand the permitted use-cases which may lead to off-label use.
Limitations: Not all intended purpose statements received were of sufficient quality to use for analysis. The definition of what information the intended purpose should contain is not clearly specified under the MDR making it hard to objectively assess or compare.