Hepatic VCAR
GE Medical Systems SCS • Radiology • 03/20/2020
Device Purpose
Hepatic VCAR is a CT image analysis software that utilizes deep learning algorithms, specifically convolutional neural networks, to automate the segmentation of the liver and hepatic artery from DICOM CT scans. This technology aims to assist clinicians by providing tools for assessing liver morphology, quantifying lesions, and tracking changes over time through enhanced visualization and measurement capabilities.
Summary
Hepatic VCAR is a CT image analysis software package designed for the analysis and visualization of liver CT data obtained from DICOM 3.0 compliant CT scans. Its primary purpose is to assist clinicians in assessing liver morphology, including the identification and measurement of liver lesions that exhibit a different CT appearance from surrounding tissue, and to track changes in these features over time. The software provides automated tools for the segmentation and measurement of the liver, liver lobes, liver segments, and liver lesions. It offers initial 3D segmentation, vessel analysis, visualization, and quantitative analysis of liver anatomy, with functionalities allowing users to adjust contours and confirm final segmentations. The system can be deployed on various platforms, including Advantage Workstation, AW Server, CT Scanners, PACS stations, or cloud environments. A significant technological advancement in this version of Hepatic VCAR is the introduction of two new algorithms utilizing deep learning technology, specifically convolutional neural networks. One algorithm automates the segmentation of the liver, producing an editable liver contour, while the other semi-automates the segmentation of the hepatic artery based on an initial user input point, with the resulting segmentation also being user-editable. This contrasts with previous methods that used traditional deterministic algorithms for liver segmentation and manual tools for vascular structures. The performance of these new deep learning algorithms was validated through bench tests against expert-annotated ground truth, confirming they performed as expected. Furthermore, an assessment involving board-certified radiologists evaluating clinical sample images demonstrated the capability of the deep learning-based liver and hepatic artery segmentation.
AI Regulatory Concerns
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Keywords
Device Metadata
Relevant Clinical Questions
- Q1. What specific types or characteristics of liver lesions are most accurately segmented by the deep learning algorithms, and are there known limitations (e.g., size, contrast, proximity to vessels)?; How does the performance (accuracy, speed, robustness) of the deep learning-based hepatic artery segmentation compare to experienced radiologists performing manual segmentation, particularly in complex vascular anatomies?; What was the range of variability in segmentation results observed during the radiologist assessment, and how does the software guide users in adjusting contours for optimal accuracy?; Are there specific CT acquisition protocols or contrast enhancement phases that optimize the performance of Hepatic VCAR's deep learning algorithms for liver and vessel segmentation?; How does the software handle temporal changes in liver morphology and lesion characteristics when comparing studies performed at different time points, especially concerning registration accuracy and consistency of segmentation?
Risk Classification
ESL AnalysisFDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement
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Powered by SBOMator™Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.
Supply Chain BOM Evidence
Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.
Analysis:
• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.
• Evidence of SBOM, ML-BOM, SaaSBOM, OBOM detected in AI-generated device summary.
• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.
• Not detected in AI-generated device summary: HBOM, CBOM, VDR/VEX. These may be present in the full FDA submission.
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