WRDensity by Whiterabbit.ai
Whiterabbit.ai Inc.WRDensity by Whiterabbit.ai is a software tool that uses deep learning to analyze digital mammography images and automatically assess breast tissue composition according to the ACR BI-RADS 5th Edition breast density categories. It helps radiologists by providing breast density categorization and probability scores, which can improve breast cancer risk assessment and patient management. The software works with various mammography systems and outputs results to PACS and RIS for clinician review.
Intended Use
WRDensity is a software application intended for use with compatible full-field digital mammography and digital breast tomosynthesis systems. WRDensity provides an ACR BI-RADS 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. WRDensity produces adjunctive information. It is not a diagnostic aid.
Technology
WRDensity is a standalone software application that automatically analyzes "for presentation" DICOM data from digital breast x-ray systems using a deep learning algorithm. It produces Breast Density Level (BDL) and Breast Density Level Probabilities (BDLP) as outputs. The outputs are sent as DICOM Secondary Capture Image and Structured Report to PACS and RIS for radiologist review.
Performance
Performance was evaluated against radiologist consensus using accuracy metrics including quadratically-weighted Cohen's kappa. On a test dataset of 871 exams, WRDensity achieved a quadratically-weighted kappa of 0.90 for the 4-class breast density task and 0.88 for the binary dense vs. non-dense task. Consistency and reproducibility were also validated according to recognized standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/21/2020
3 months - 2
FDA Approval
10/30/2020
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