ProFound AI Software V2.1 is an AI-based software designed to assist radiologists in detecting soft tissue densities and calcifications in 3D digital breast tomosynthesis images. It highlights suspicious breast lesions by marking areas in the images and assigns confidence scores to help physicians identify likely malignant regions, supporting earlier and more accurate breast cancer diagnosis.
Intended Use
ProFound AI V2.1 is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting physician.
Technology
Uses deep learning technology for feature computation and pattern recognition to detect malignant soft tissue densities and calcifications in 3D digital breast tomosynthesis (DBT) images. Marks and scores detected regions with an algorithm confidence representing likelihood of malignancy, displayed as overlays on DBT images. Supports multiple DBT systems including Hologic, GE, and Siemens models.
Performance
The software underwent verification and validation including unit, integration, regression, system testing, and clinical performance studies. Standalone studies on Siemens DBT image datasets demonstrated that sensitivity, specificity, and false positive rates met performance specifications and were statistically non-inferior to the predicate device tested on Hologic DBT images.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/26/2019
2 months - 2
FDA Approval
10/4/2019
Other devices from iCAD Inc.
- ProFound Detection (V4.0)2024 • 510K
- PowerLook Density Assessment V4.02021 • 510K
- ProFound AI Software V3.02021 • 510K
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