QUANTRA
HOLOGIC, INC.Quantra is a software application used with digital breast x-ray images to calculate volumetric and area breast density. It aids radiologists by providing quantitative breast tissue composition data to help in consistent breast density reporting. It does not interpret images directly but supports breast cancer risk assessment and reporting.
Intended Use
Quantra™ is a software application intended for use with images acquired using digital breast x-ray systems. It calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates, and provides area breast density as a ratio of fibroglandular tissue area and total breast area estimates. Quantra categorizes breast density helpful in reporting consistent BI-RADS breast composition categories. It produces adjunctive information to aid radiologists in breast tissue composition assessment but is not an interpretive or diagnostic aid.
Technology
The Quantra software calculates volumetric and area measurements of breast tissue from digital x-ray images. It operates on a Windows server, processing images from various digital breast x-ray systems, without direct patient contact or control of devices. The algorithm estimates breast tissue volume and area, updated in version 2.1 for independence from certain acquisition parameters and uses a new reference population dataset.
Performance
Performance testing included accuracy assessment using breast phantoms, reproducibility studies comparing images across acquisition systems, statistical evaluation of density measures between views and breasts, and comparison with BI-RADS category scores from multiple readers. These studies demonstrated acceptable safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/28/2014
2 months - 2
FDA Approval
10/10/2014
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