CoLumbo C-Spine

CoLumbo C-Spine is medical imaging software that analyzes cervical spine MRI images to automatically segment vertebrae (C3-C7) and disks (C2C3-C7T1), perform measurements, and flag out-of-range results. The software is intended as a clinical decision support tool for radiologists and spine surgeons in hospitals; it does not diagnose or recommend treatment.

The subject device focuses on cervical spine MR imaging, whereas the predicate (CoLumbo) analyzes lumbar spine. Both use threshold-based labeling of out-of-range measurements, support MR modality, and provide segmentation, measurement, and result export. The patient population differs slightly: cervical device supports ages 22+; lumbar device supports ages 18+. Both are Class II devices under the same CFR classification (21 CFR 892.2050, product code QIH).

Not stated in this summary. The document references ISO 13485 and ISO 13484 design controls and quality requirements but does not cite specific test methods or consensus standards for device performance validation.

CoLumbo C-Spine is substantially equivalent because it has the same intended use, similar technological characteristics, and the same principles of operation (segmentation, measurement, threshold-labeling) as the predicate CoLumbo device. Minor differences in anatomical focus (cervical vs. lumbar) and patient age range do not alter the intended use or raise new safety/effectiveness questions. Performance validation on 95 MRI c-spine studies demonstrates the software performs as intended with acceptable accuracy metrics.