See-Mode Augmented Reporting Tool, Breast (SMART-B)
See-Mode Technologies Pty, Ltd.The See-Mode Augmented Reporting Tool, Breast (SMART-B), is a software platform that uses AI to help radiologists analyze breast ultrasound images. It automatically highlights suspicious soft tissue breast lesions, provides standardized BI-RADS descriptors and categories, and streamlines structured reporting. The tool is designed to improve detection and reporting accuracy for clinicians interpreting ultrasound scans for patients with breast lesions.
Intended Use
Assist trained interpreting physicians in analyzing breast ultrasound images of patients with soft tissue breast lesions who are being referred for diagnostic ultrasound. The tool localizes suspicious lesions from two orthogonal views, provides BI-RADS category and descriptors, and may be used to generate structured reports. It is intended as a tool to aid, not replace, physician judgment.
Technology
SMART-B is a web-based machine learning software that processes DICOM breast ultrasound images, localizes soft tissue lesions using AI algorithms, assigns BI-RADS categories and descriptors, and generates structured reports. It accepts images via standard DICOM interfaces, uses automated ROI generation, and allows user modification before report finalization.
Performance
Device performance was validated in both a multi-reader multi-case (MRMC) study (n=589 patients, 16 radiologists) and a standalone study (n=972 unique patients). In the MRMC, use of SMART-B significantly improved reader localization and diagnostic accuracy (increase in LROC AUC from 0.824 to 0.897 with aid, p=0.001). The standalone device achieved an AUCLROC of 0.901, sensitivity of 94.7%, and specificity of 51.4%. Software verification and validation followed FDA and IEC 62304 standards.
Predicate Devices
No predicate devices specified
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