Transpara
Screenpoint Medical B.V.Transpara is an AI-powered software designed to assist radiologists in detecting and diagnosing breast cancer from screening mammograms. It highlights suspicious soft tissue lesions and calcifications and provides likelihood scores for cancer presence, helping clinicians make more informed decisions during mammogram interpretation.
Intended Use
The ScreenPoint Transpara™ system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms from compatible FFDM systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy.
Technology
Transpara is a software-only device consisting of a processing server and optional viewer, applying machine learning algorithms trained on large biopsy-proven datasets to detect suspicious calcifications and soft tissue lesions on mammograms. It outputs CAD marks, region-based suspiciousness scores, and an overall risk score, integrating via DICOM protocols for radiology workstation compatibility.
Performance
Performance testing included software verification and validation on a multi-vendor mammogram dataset not used for training, demonstrating improved detection performance over the predicate device across mammography systems from five manufacturers. A pivotal clinical reader study was also conducted to establish safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/22/2019
3 months - 2
FDA Approval
12/10/2019
Other devices from Screenpoint Medical B.V.
- Transpara (2.1.0)2024 • 510K
- Transpara Density 1.0.02023 • 510K
- Transpara 1.7.22022 • 510K
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