Table 4 Two examples of disclaimers that contradicted the claim in the intended use statement

A chest CT AI tool:

“It is a tool used to support the oncological workflow by helping the user confirm the absence or presence of lesions, […]. […] it does not directly generate any diagnosis or potential findings.”

A breast density AI tool:

“[…]. [PRODUCT] calculates and quantifies a density map and from that determines volumetric breast density […]. [PRODUCT] is not an interpretive or diagnostic aid […]”

A chest X-ray AI tool:

“The device […] provides a list of suspected findings on the chest X-ray […] and is able to identify the location of the suspected abnormalities. […] It is not intended to be used as a diagnostic device, a source of medical advice or to aid in determining patient management plan. […] Clinicians are responsible for viewing the original chest X-rays as per the standard of care.”