CoLumboX
Smart Soft Healthcare ADCoLumboX is a software tool that helps healthcare professionals analyze lumbar spine x-ray images by automatically segmenting and measuring spine features. It provides quantitative information and highlights out-of-range measurements to assist in clinical evaluations, supporting more efficient and accurate patient assessments without making diagnoses itself.
Intended Use
CoLumboX is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine radiograph x-ray images for users’ review, analysis, and interpretation.
Technology
The device performs automated segmentation of vertebrae and sacrum from lumbar spine x-ray images, calculates quantitative measurements such as spondylolisthesis slippage, and labels out-of-range measurements based on user-defined thresholds. It outputs measurement results and supports clinical workflow without providing diagnosis.
Performance
Software design verification testing and an external clinical data-based performance assessment study with 100 lumbar spine x-ray studies demonstrated conformance with medical device software standards. Cybersecurity testing confirmed no critical vulnerabilities. The performance study showed that CoLumboX outputs are consistent with measurements by radiologists, ensuring safety and effectiveness.
Predicate Devices
No predicate devices specified
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