OsteoDetect
Imagen Technologies, Inc. • Radiology • 05/24/2018
Device Purpose
OsteoDetect is an advanced computer-aided detection system that utilizes a convolutional neural network to analyze wrist X-ray images (PA and lateral views) for the identification of distal radius fractures. It serves as an adjunct tool integrated into PACS workstations, aiming to improve radiologists' diagnostic accuracy and efficiency by automatically highlighting potential fracture sites with high sensitivity and specificity.
Summary
OsteoDetect is a specialized computer-aided detection (CAD) system engineered to assist medical professionals in identifying distal radius fractures through the analysis of wrist X-ray images. The system employs a sophisticated convolutional neural network (CNN) to process both posteroanterior (PA) and lateral radiographic views of the wrist. Designed for seamless integration into Picture Archiving and Communication System (PACS) workstations, OsteoDetect automatically highlights potential areas of concern by drawing a bounding box on the image, which is then labeled either “Fracture Detected” or “Not Detected,” providing an initial screening for subsequent expert review by a radiologist. The efficacy of OsteoDetect has been substantiated through validation studies, which demonstrate its high performance with an approximate sensitivity of 97% and specificity of 92%. These figures underscore the system's capability for both identifying fractures when they are present and correctly indicating their absence, thereby facilitating rapid and accurate fracture marking. OsteoDetect is intended to function as an adjunct diagnostic tool, augmenting the radiologist's expertise rather than replacing it. The ultimate aim is to enhance the overall diagnostic capabilities of clinicians in detecting wrist fractures, leading to more efficient clinical workflows and more precise patient assessments in radiological practice.
AI Regulatory Concerns
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Keywords
Device Metadata
Relevant Clinical Questions
- Q1. How does OsteoDetect's performance vary with different X-ray machine models or image acquisition protocols?; What was the demographic diversity (age, sex, ethnicity) of the patient population used in the validation studies, and how might this affect its generalizability?; Are there studies comparing the diagnostic outcomes and radiologist workload with and without the use of OsteoDetect in a prospective clinical setting?; How does the system handle subtle or hairline fractures compared to more obvious displacements, and what is the threshold for detection?; What are the computational requirements for OsteoDetect, and how does its processing time impact real-time clinical workflow in high-volume emergency departments?
Risk Classification
ESL AnalysisFDA Class II via De Novo 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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