TechCare Trauma by Milvue is an AI software that analyzes 2D X-ray images to help clinicians detect, localize, and characterize fractures and elbow joint effusions in a wide range of anatomical areas and patient populations including neonates, children, and adults. The software integrates into existing medical imaging workflows and supports clinicians by highlighting suspicious findings, improving diagnostic accuracy without replacing primary clinical decision-making.
Intended Use
TechCare Trauma is intended to analyze 2D X ray radiographs using machine learning techniques to aid in the detection, localization, and characterization of fractures and/or elbow joint effusion during the review of commonly acquired radiographs.
Technology
TechCare Trauma is a Software as a Medical Device (SaMD) that uses a deep learning artificial intelligence algorithm to analyze 2D X-ray radiographs. It integrates via DICOM interfaces in clinical imaging workflows and can be deployed on-premises or in the cloud. It outputs annotated images with bounding boxes denoting findings and generates summary images and optionally DICOM Structured Reports.
Performance
Performance testing included standalone model validation and a multiple-reader multiple-case (MRMC) clinical study with adult and pediatric patient populations. Testing showed high accuracy (ROC-AUC approximately 0.96) for fracture and elbow joint effusion detection. The clinical study demonstrated statistically significant improvement in reader diagnostic accuracy with TechCare Trauma assistance compared to unaided reading.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/24/2024
5 months - 2
FDA Approval
1/17/2025
Other devices from Milvue
- SmartChest2024 • 510K
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