ProFound AI Software V3.0 is an AI-based medical imaging software that aids radiologists by detecting and highlighting suspicious soft tissue densities and calcifications in 3D digital breast tomosynthesis images. It provides confidence scores that help clinicians identify potentially malignant findings more quickly and accurately during breast cancer screening and diagnosis.
Intended Use
ProFound AI® V3.0 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
ProFound AI V3.0 uses deep learning technology for lesion detection in 3D DBT images, detecting soft tissue densities and calcifications by marking lesion contours in slices. It assigns Certainty of Finding and Case Scores representing algorithm confidence ranging from 0% to 100%. The software overlays detection marks on images and supports multiple DBT systems.
Performance
ProFound AI V3.0 was verified and validated via unit, integration and regression testing, and network integration testing on DICOM platform. Non-clinical validation compared V3.0 performance with predicate V2.0 on Hologic and GE DBT images, demonstrating non-inferiority and significantly improved specificity.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/29/2020
2 months - 2
FDA Approval
3/12/2021
Other devices from iCAD Inc.
- ProFound Detection (V4.0)2024 • 510K
- PowerLook Density Assessment V4.02021 • 510K
- ProFound AI Software V2.12019 • 510K
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