FDA & CE | Breast | FFDM & DBT | Amplifier Partner

Description of use

Transpara® is a software only application designed to be used by physicians to improve interpretation of digital mammography and digital breast tomosynthesis (DBT, or 3D mammography). Deep learning algorithms are applied to Full-Field Digital Mammography (FFDM) images and DBT slices for recognition of suspicious calcifications and soft tissue lesions (including densities, masses, architectural distortions, and asymmetries). Algorithms are trained with a large database of biopsy-proven examples of breast cancer, benign abnormalities, and examples of normal tissue.

Transpara® offers the following functions which may be used at any time in the reading process, to improve detection of abnormalities and workflow:
a) Computer aided detection (CAD) marks to highlight locations where the device detected suspicious calcifications or soft tissue lesions.
b) Decision support is provided by region scores on a scale ranging from 1-100, with higher scores indicating a higher level of suspicion.
c) Links between corresponding regions in different views of the breast, which may be utilized to enhance user interfaces and workflow.
d) An exam-based score which categorizes exams on a scale of 1-10 with increasing likelihood of cancer. The score is calibrated in such a way that approximately 10 percent of mammograms in a population of mammograms without cancer falls in each category.

The concurrent use indication implies that it is up to the users to decide how to use Transpara in the reading process. Transpara functions can be used before, during or after visual interpretation of an exam by a user, as decision support, as an independent second reader, or as a tool to optimize workflow. If double reading is practiced, users may decide to use Transpara as a (partial) replacement of a second reader or as a third reader.

Benefits of Transpara

  • Reduces both reading times and workload
  • Improves both 2D and 3D breast cancer detection accuracy
  • Helpful in detecting cancers earlier

Regulatory Clearance:
FDA Cleared, CE Mark Approved, Health Canada Licensed

The application content is provided by the respective AI vendors.