CoLumboX

CoLumboX is image post-processing software that analyzes previously-acquired DICOM lumbar spine x-ray images to provide quantitative measurements of spine features. It performs feature segmentation, measurement, threshold-based labeling of out-of-range values, and exports results to assist radiologists and spine surgeons in visualization and documentation. The software does not produce diagnoses or treatment recommendations; users retain full control and responsibility for interpreting results.

CoLumboX provides comparable outputs to its predicate device in segmentation, measurement, and labeling functionality. Both devices use rule-based algorithms with user-defined thresholds to classify measurements. The primary difference from the predicate (CoLumbo) is that CoLumboX processes x-ray images rather than MR images, aligning it with the reference device (Spine CAMP) modality while maintaining the same intended user population and patient age restrictions (18+, excluding pregnant patients and those with post-operative complications, tumors, or infections).

Not stated in this summary.

CoLumboX is substantially equivalent because it has the same intended use (assisting radiologists and spine surgeons in routine evaluation of lumbar spine imaging), identical technological principles (feature segmentation, measurement, threshold-based labeling, and result export), and equivalent safety and effectiveness profiles. The change from MR to x-ray modality does not introduce new safety or effectiveness concerns since both the predicate and reference devices demonstrate the same functional approach to spine measurement. Clinical validation with 100 patient studies and cybersecurity testing confirm the software performs as intended in specified use conditions.