Transpara Density 1.0.0
Screenpoint Medical B.V.Transpara Density 1.0.0 is an AI-powered software designed to assist healthcare professionals in assessing breast tissue composition from digital mammography and tomosynthesis images. It automatically calculates volumetric breast density, breast volume, and categorizes breast density according to ACR BI-RADS 5th Edition. This helps radiologists make informed decisions about breast cancer screening and diagnosis.
Intended Use
Software application intended for use with data from compatible digital mammography and digital breast tomosynthesis systems, utilizing AI algorithms to automatically determine volumetric breast density, breast volume, and an ACR BI-RADS 5th Edition breast density category to aid healthcare professionals in assessing breast tissue composition. It is not a diagnostic aid.
Technology
Transpara Density is a software module that uses deep learning AI techniques to assess breast density from processed digital mammography and tomosynthesis images, outputting volumetric breast density, breast volume, and BI-RADS 5th Edition density category. It operates as an optional feature within Transpara and requires embedding in an application that supports standardized formats like DICOM and communication with PACS.
Performance
Performance testing showed high accuracy and reproducibility. The volumetric breast density correlated strongly with a validated physics-based model (Pearson r=0.935) and breast MRI (Pearson r=0.908). Reproducibility was confirmed across views and breasts with high correlation coefficients. Agreement with eight MQSA-qualified radiologists showed 70.8% accuracy for four-category breast density and 88.9% for dense vs. non-dense classification, with sensitivities of 87.3% and specificity of 90.4%. Compatibility was demonstrated with multiple vendor data.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/13/2023
5 months - 2
FDA Approval
12/11/2023
Other devices from Screenpoint Medical B.V.
- Transpara (2.1.0)2024 • 510K
- Transpara 1.7.22022 • 510K
- Transpara 1.7.02021 • 510K
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