CoLumbo
Smart Soft Healthcare ADCoLumbo is a medical imaging AI software tool designed to assist radiologists and spine surgeons by automatically segmenting and measuring lumbar spine features from MRI images. It highlights out-of-range measurements and generates reports for review and approval by clinicians, improving the efficiency and consistency of lumbar spine evaluation, but does not provide diagnosis.
Intended Use
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine MR images for users' review, analysis, and interpretation. It provides feature segmentation, feature measurement, threshold-based labeling of out-of-range measurements, and export of measurements to reports for user review and approval. It does not produce or recommend diagnosis or treatment and is intended for use only by hospitals and medical institutions on images of patients aged 18 and above without certain excluded conditions.
Technology
CoLumbo uses deep convolutional image-to-image neural networks for semi-automatic segmentation and measurement of lumbar spine features from DICOM MRI images. Users confirm, modify, and approve threshold-based labeling of out-of-range measurements. The tool outputs segmentations and quantitative measurements, which must be reviewed and validated by the user prior to reporting. The software supports visualization and measurement but is not diagnostic.
Performance
Performance testing included software verification and validation, cybersecurity, usability (human factors), and a standalone clinical performance study. The clinical study compared CoLumbo outputs to ground truth segmentations and measurements established by three radiologists on 101 MR studies across multiple US sites and manufacturers. Results showed measurement errors and segmentation Dice coefficients within predefined acceptance criteria, demonstrating accuracy across subgroups by age, sex, race, and scanner type. No clinical studies were conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/22/2022
4 months - 2
FDA Approval
6/23/2022
Other devices from Smart Soft Healthcare AD
- CoLumbo2024 • 510K
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