Semiautonomous Deep Learning Breast Cancer Rule-out System for Screening Mammography
model2025-11-29https://doi.org/10.1148/atlas.1764446602310
81

Overview

Schema Version

https://atlas.rsna.org/schemas/2025-11/model.json

Name

Semiautonomous Deep Learning Breast Cancer Rule-out System for Screening Mammography

Link

https://dx.doi.org/10.1148/ryai.230033

Indexing

Keywords: Artificial Intelligence, Semiautonomous Deep Learning, Breast Cancer, Screening Mammography, Rule-out system, False-positive reduction
Content: BR
RadLex: RID36027, RID45682, RID10357

Author(s)

Stefano Pedemonte
Trevor Tsue
Brent Mombourquette
Yen Nhi Truong Vu
Thomas Matthews
Rodrigo Morales Hoil
Meet Shah
Nikita Ghare
Naomi Zingman-Daniels
Susan Holley
Catherine M. Appleton
Jason Su
Richard L. Wahl

Organization(s)

Whiterabbit.ai
Onsite Women's Health
SSM Health
Mallinckrodt Institute of Radiology, Washington University School of Medicine
Royal Surrey NHS Foundation Trust (OPTIMAM project team)

Version

1.0

License

Text: CC BY 4.0
URL: https://creativecommons.org/licenses/by/4.0/

Contact

ia.tibbaretihw@hcraeser

Funding

Supported by Whiterabbit.ai. Washington University in St. Louis has equity interests in Whiterabbit.ai and may receive royalty income and milestone payments per an agreement with Whiterabbit.ai to develop the technology.

Ethical review

IRB approvals obtained; informed consent waived; data handled according to HIPAA.

Date

Updated: 2024-05-01
Published: 2024-04-10
Created: 2023-02-02

References

[1] Pedemonte S, Tsue T, Mombourquette B, et al.. "A Semiautonomous Deep Learning System to Reduce False Positives in Screening Mammography". Radiology: Artificial Intelligence. 2024;6(3):e230033.. 2024-04-10. doi:10.1148/ryai.230033. PMID: 38597785. PMCID: PMC11140506.

Model

Architecture

Two-stage deep learning system: low-level vision model analyzes each mammogram image independently; high-level vision metamodel integrates multi-view, bilateral, and prior imaging along with age and prior BI-RADS assessments to produce an exam-level malignancy probability.

Clinical benefit

Reduces screening mammograms requiring radiologist interpretation, decreases false-positive callbacks and benign biopsies while maintaining cancer detection rate within a predefined noninferiority margin.

Clinical workflow phase

Patients’ triage; workflow optimization; clinical decision support for screening mammography.

Decision threshold

Rule-out operating threshold selected on validation data to achieve target 12-month sensitivity of 99% (and alternatively 97%). Exams with scores below threshold are assigned BI-RADS 1 by the device.

Degree of automation

Semiautonomous rule-out: automatically assigns BI-RADS 1 to a subset of nonsuspicious screening exams; remaining exams proceed to standard radiologist interpretation.

Indications for use

Identification of screening mammograms not suspicious for breast cancer in a screening population, to reduce radiologist workload and false-positive downstream events in screening programs (US and UK settings).

Input

2D full-field digital mammography images (multi-view, bilateral), patient age, prior mammogram images, and prior exam BI-RADS assessments when available.

Instructions

Device reads examinations before radiologists. Exams with prediction below the rule-out threshold are automatically labeled BI-RADS 1 (negative) and removed from radiologist workflow; all others are read by radiologists as usual. Site- and scanner-specific operating point selection may be considered.

Limitations

Retrospective simulation; assumes radiologist behavior unaffected by removal of exams. Performance varies by scanner model (HSE vs SED) due to training data imbalance. Limited tracking of false negatives in one dataset (US2). Test sets include multiple exams per patient which may underestimate variance. Radiologist false negatives include interval cancers likely not visible at screening. Prospective reader studies and QA/monitoring systems are needed.

Output

CDEs: RDE858
Description: Exam-level malignancy probability and binary rule-out decision; for scores below threshold, assigned BI-RADS 1 (nonsuspicious) versus send to radiologist.

Recommendation

Operate at high-sensitivity rule-out thresholds; consider site/scanner model when selecting operating point; further prospective validation and QA monitoring recommended.

Reproducibility

Evaluation conducted on retrospective datasets with specified splits; performance reported with prevalence adjustments, noninferiority tests, and bootstrap CIs. Code not provided.

Use

Intended: Detection and diagnosis
Out-of-scope: Detection and diagnosis
Excluded: Other

User

Intended: Subspecialist diagnostic radiologist, Administrator
Out-of-scope: Layperson
Excluded: Patient, Layperson