RUS
Hutom Inc.RUS by Hutom Inc. is a medical imaging software designed to aid healthcare professionals in reading, interpreting, and planning treatment based on iodine contrast-enhanced abdominal CT scans. The software provides basic imaging tools, 3D modeling, and segmentation of anatomical structures, including organs and vessels, enhancing surgical planning and diagnosis. It incorporates AI-based machine learning models to improve accuracy in organ segmentation, vessel detection, and pneumoperitoneum analysis, supporting clinicians in patient management decisions.
Intended Use
RUS is medical imaging software intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for patients using iodine contrast-enhanced abdomen CT images.
Technology
RUS uses DICOM standard to receive CT images, includes three software components (h-Server, h-Space, RUS Stomach Planning), and uses AI machine learning models (CADD U-NET for organs, 3D U-NET for vessels, linear regression for pneumoperitoneum) to segment anatomical structures and reconstruct 3D models for clinical evaluation and surgical planning.
Performance
Performance testing evaluated RUS on 60 independent CT imaging studies not used in training, showing high accuracy with Dice coefficient scores of 0.927 for organs, 0.920 for vessels, and a pneumoperitoneum mean absolute error of ±0.972 mm, supporting substantial equivalence to predicate devices. Length measurement accuracy was validated within ±10%.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/20/2023
8 months - 2
FDA Approval
7/12/2024
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