densitas densityai
Densitas, Inc.Densitas densityai is a software application that analyzes digital mammography and breast tomosynthesis images to automatically assess breast tissue density. It provides a Breast Density Grade according to the American College of Radiology's BI-RADS 5th Edition to assist physicians in evaluating breast composition. This adjunctive tool helps interpret breast density consistently and efficiently, enhancing clinical decision-making in breast cancer screening.
Intended Use
Densitas densityai is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. It provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. It produces adjunctive information and is not a diagnostic aid.
Technology
The software processes digital mammography 'for presentation' images and digital breast tomosynthesis exams using proprietary algorithms. It outputs a Breast Density Grade following ACR BI-RADS 5th Edition classification. Results are packaged for viewing on mammography workstations or PACS as DICOM mammography Structured Reports or Secondary Capture, and can also be transmitted to RIS. Processing speed is approximately 600 cases per hour.
Performance
No human clinical testing was required. Non-clinical performance testing included internal verification and validation with expert radiologist assessments. Reliability, accuracy, and reproducibility were tested using statistical methods including Pearson’s Correlation Coefficient and Kappa statistics. Results showed substantial agreement with expert consensus readings across multiple compatible scanner types.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/24/2019
3 months - 2
FDA Approval
2/19/2020
Other devices from Densitas, Inc.
- DM-Density2018 • 510K
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