Retrospective evaluation of a CE-marked AI system, including 1,017,208 mammography screening examinations.

ABSTRACT:

Objectives

To retrospectively evaluate the performance of a CE-marked AI system for identifying breast cancer on screening mammograms. Evidence from large retrospective studies is crucial for planning prospective studies and to further ensure safe implementation.

Materials and methods

We used data from screening examinations performed from 2004 to 2021 at ten breast centers in BreastScreen Norway. In the standard independent double reading setting, each radiologist scored each breast from 1 (negative) to 5 (high probability of cancer). The AI system assigned each examination an NT and an SN score; the NT score aimed to classify examinations as negative with minimal misclassification while the SN score aimed to classify examinations as positive with high confidence. N70 was d

SUBMITTER: Hovda T 

PROVIDER: S-EPMC12350444 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature