Transpara (2.1.0)
ScreenPoint Medical B.V.Transpara (2.1.0) is an AI software tool designed to assist doctors during screening mammography and digital breast tomosynthesis exams. It analyzes breast images to detect suspicious calcifications and soft tissue lesions and provides scores indicating the likelihood of cancer. This helps clinicians improve detection accuracy and workflow, but decisions should not be made solely on its output.
Intended Use
Transpara software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy.
Technology
Transpara is a software-only device that employs deep learning algorithms trained on biopsy-proven cases for recognizing suspicious calcifications and soft tissue lesions in digital mammography and tomosynthesis images. It outputs locations and likelihood scores of suspicious findings and integrates with medical workstations and PACS using DICOM standards.
Performance
Performance was evaluated on a large multi-center dataset of over 10,000 mammography exams, including biopsy-proven cancers. The device demonstrated high sensitivity and specificity at detecting breast cancer lesions. Temporal analysis comparing prior exams further improved performance, and subgroup analyses showed consistent results across patient demographics and lesion types.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/25/2024
5 months - 2
FDA Approval
11/25/2024
Other devices from ScreenPoint Medical B.V.
- Transpara Density 1.0.02023 • 510K
- Transpara 1.7.22022 • 510K
- Transpara 1.7.02021 • 510K
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