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Lunit INSIGHT DBT is a computer-assisted detection and diagnosis (CADe/x) software intended to be used concurrently by interpreting physicians to aid in the detection and characterization of suspected lesions for breast cancer in digital breast tomosynthesis (DBT) exams from compatible DBT systems. Through the analysis. the regions of soft tissue lesions and calcifications are marked with an abnormality score indicating the likelihood of the presence of malignancy for each lesion. Lunit INSIGHT DBT uses screening mammograms of the female population.

Lunit INSIGHT DBT is not intended as a replacement for a complete interpreting physician's review or their clinical judgment that takes into account other relevant information from the image or patient history.

Lunit INSIGHT DBT is a computer-assisted detection/diagnosis (CADe/x) software as a medical device that provides information about the presence, location and characteristics of lesions suspicious for breast cancer to assist interpreting physicians in making diagnostic decisions when reading digital breast tomosynthesis (DBT) images. The software automatically analyzes digital breast tomosynthesis slices via artificial intelligence technology that has been trained via deep learning.

For each DBT case, Lunit INSIGHT DBT generates an artificial intelligence analysis results that include the lesion type, location, lesion-level case-level score, and outline of the regions suspected of breast cancer. This peripheral information intends to augment the physician's workflow to better aid in detection and diagnosis of breast cancer.

Here's a breakdown of the acceptance criteria and the study proving the device, Lunit INSIGHT DBT, meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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