Transpara 1.7.0
ScreenPoint Medical B.V.Transpara 1.7.0 is an AI software tool designed to assist physicians in interpreting breast imaging exams such as digital mammography and tomosynthesis. It uses deep learning algorithms to detect suspicious calcifications and soft tissue lesions, scoring their likelihood of malignancy to aid diagnosis and improve workflow. It processes images to highlight abnormal areas and provides exam-level cancer likelihood scores, supporting better identification of breast cancer indicators.
Intended Use
Transpara software is intended as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams, identifying regions suspicious for breast cancer and assessing likelihood of malignancy.
Technology
Transpara is a software-only application employing deep learning algorithms applied to FFDM and DBT image slices to detect and characterize calcifications and soft tissue lesions suspicious for breast cancer. It outputs CAD marks, region scores (0-100), and an exam score (1-10) indicating malignancy likelihood, implemented on standard PC hardware or virtual servers, integrating via DICOM.
Performance
Verification and standalone validation involved independent datasets from multiple manufacturers and centers, showing high sensitivity for calcifications (94.7%) and soft tissue lesions (80.2% at 0.02 FP/image) in 2D, and 91.3% sensitivity at 0.3 FP/volume in DBT. ROC analysis demonstrated non-inferior and statistically higher AUC compared to predicate device. Risk management and usability standards were followed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/10/2021
3 months - 2
FDA Approval
6/2/2021
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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