Bone VCAR (BVCAR)
GE Medical Systems SCS • Radiology • 04/08/2019
Device Purpose
Bone VCAR is an advanced post-processing software designed to enhance the analysis of CT images of the spine by utilizing deep learning for automated vertebrae identification and labeling. Its methodology aims to improve clinical workflow efficiency and accuracy in radiological reporting by providing optimized visualization tools and streamlined image review processes.
Summary
Bone VCAR is a software analysis package designed as a post-processing application for computed tomography (CT) images, specifically to aid clinicians in the assessment and reporting of images that include the spine. Utilizing a deep learning technique, the software analyzes CT data to provide an optimized display and quick access to tools that enhance the reading experience and efficiency for anatomical review. It operates on platforms such as the Advantage Workstation (AW), CT Scanners, Cloud, or PACS stations, and its core function is to support clinicians in visualizing the spine by automatically identifying and labeling vertebrae, which assists in report dictation. The system is compatible with both single energy and Gemstone Spectral Imaging (GSI) acquisition methods and is intended for use across multiple care areas including trauma, oncology, and routine body exams, without being specific to any particular disease state. Key functionalities of Bone VCAR include Multiplanar Reconstruction (MPR) displays in various views (axial, sagittal, coronal, oblique, x-section, curved) and modes (thin/thick, Average, MIP, MinIP, Volume Rendering), automatic generation of anatomical labels and curved views with full editing capabilities, and access to standard volume viewer tools for measurements and annotations. The software allows for synchronization of views when multiple series are loaded and offers users flexibility in utilizing its features. Algorithm validation demonstrated a success rate greater than 90% for automatic spine labeling. Furthermore, a clinical assessment by board-certified radiologists indicated that Bone VCAR's automated labeling is faster than manual methods, significantly improves reading and reporting efficiency, and ensures accurate vertebra identification.
AI Regulatory Concerns
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Relevant Clinical Questions
- Q1. What specific deep learning architecture does Bone VCAR utilize for vertebrae identification and labeling, and how was its training dataset constructed to account for anatomical variance and pathological conditions?; How does the performance of Bone VCAR's automated spine labeling, in terms of accuracy and processing time, compare against other leading automated systems when challenged with complex cases like severe scoliosis or post-surgical changes?; Can Bone VCAR differentiate and label pathological features or anomalies in the vertebrae, or is its functionality strictly limited to identifying normal anatomical structures?; What are the specific image acquisition parameters (e.g., slice thickness, contrast protocols) that yield optimal performance for the Bone VCAR software, and how does it handle suboptimal image quality?; Beyond spine labeling, are there plans to extend the Bone VCAR deep learning technology to other anatomical regions or to incorporate quantitative analysis features?
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 ML-BOM, SaaSBOM detected in AI-generated device summary.
• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.
• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.
• Not detected in AI-generated device summary: SBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.
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