PowerLook® Tomo Detection Software by iCAD Inc is an AI-based computer-assisted detection tool designed to help radiologists more quickly and effectively interpret digital breast tomosynthesis (DBT) exams. It detects soft tissue densities such as masses, architectural distortions, and asymmetries in 3D DBT images and enhances a 2D synthetic mammography image to highlight these detections. This assists radiologists in identifying potentially suspicious areas to improve diagnostic accuracy while reducing reading time.
Intended Use
Computer-assisted detection software device to be used concurrently by radiologists while reading GE Senoclaire breast tomosynthesis exams to detect up to five soft tissue densities (masses, architectural distortions, and asymmetries) in 3D images.
Technology
The software applies pattern recognition technology trained on sample soft tissue densities to 3D breast tomosynthesis images, detects up to five suspicious soft tissue density regions, and blends these detections onto a 2D synthetic mammography image without adding CAD marks. The enhanced image assists radiologists by highlighting potential lesions while preserving the original tomosynthesis image context.
Performance
Clinical pivotal reader study with 20 radiologists reading 240 DBT cases (mixed benign, malignant, recalled, and negative) in a crossover design showed the software enabled non-inferior diagnostic performance (AUC non-inferiority margin 0.05 met) and a statistically significant 29.2% reduction in reading time. Lesion detection sensitivity was also non-inferior. No adverse events reported. Software validation and bench testing confirmed requirements.
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