PowerLook Tomo Detection V2 Software by iCAD Inc. is an AI-based computer-assisted detection and diagnosis tool that helps physicians identify suspicious lesions and calcifications in digital breast tomosynthesis images. It provides confidence scores to assist in evaluating findings, improving radiologist accuracy and reducing reading time during breast cancer screening exams.
Intended Use
PowerLook® Tomo Detection V2 software 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
PowerLook Tomo Detection V2 uses deep learning techniques for feature computation and pattern recognition to identify suspected lesions in DBT images. It outputs detection marks and computes Certainty of Finding and Case Scores on a 0-100% scale reflecting the algorithm's confidence of malignancy. Compatible with Hologic Selenia Dimensions and GE Pristina DBT systems, it operates as standalone software within the PowerLook AMP framework.
Performance
Performance was evaluated via standalone testing on Hologic and GE DBT datasets and a pivotal reader study with 24 radiologists on 260 cases. Results demonstrated non-inferior and statistically superior diagnostic performance (AUC) with CAD use and significantly improved reading times. Sensitivity improved at both case and lesion levels, with maintained or improved specificity and reduced recall rates in non-cancer cases.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/31/2018
3 months - 2
FDA Approval
12/6/2018
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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