DM-Density
Densitas, Inc.DM-Density is an AI-based software that processes digital mammogram images to automatically calculate breast density, providing numerical values and breast density grades to assist physicians in assessing breast tissue composition. It supports clinical use by delivering standardized breast density information following BI-RADS classifications, integrating with mammography workstations or PACS.
Intended Use
DM-Density is a software application intended for use with compatible full field digital mammography systems. It calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates and provides numerical values for each breast as well as a density category to aid interpreting physicians in assessing breast tissue composition. It produces adjunctive information and is not a diagnostic aid.
Technology
DM-Density uses proprietary algorithms to automatically analyze full field digital mammogram images to calculate breast density according to BI-RADS density classification scales (4th and 5th editions). The software processes images 'for presentation' and outputs data as DICOM Structured Reports or Secondary Capture images compatible with mammography workstations, PACS, or RIS.
Performance
Performance testing included verification and validation demonstrating reliability, accuracy, reproducibility, and consistency of breast density measurements using expert radiologist assessments. Validation involved statistical analysis such as Pearson’s Correlation Coefficient and Kappa statistics on mammograms to confirm measurement precision and agreement. No human clinical trials were required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/23/2017
1 year - 2
FDA Approval
2/23/2018
Other devices from Densitas, Inc.
- densitas densityai2020 • 510K
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