CoLumbo
Smart Soft HealthcareCoLumbo is a software tool that helps radiologists and spine surgeons analyze MRI images of the lumbar spine by automatically segmenting anatomical features and measuring spine structures. It identifies out-of-range measurements and assists users in documenting findings, streamlining the review and reporting process without making any medical diagnosis.
Intended Use
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR) images for users' review, analysis, and interpretation. It assists users in visualizing, measuring, and documenting out-of-range measurements including feature segmentation, measurement, threshold-based labeling, and generating reports.
Technology
CoLumbo uses a deep convolutional image-to-image neural network algorithm for segmentation and quantitative analysis of lumbar spine features in MRI images. It provides automated feature segmentation, measurements with user-set thresholds for out-of-range labeling, and exports reports. The software outputs are reviewed and confirmed by users before reporting.
Performance
Performance testing included software design verification, a standalone software performance assessment study using 100 MRI spine images compared to radiologist-defined ground truth, and cybersecurity vulnerability assessment. Testing demonstrated conformance with FDA recognized standards and satisfactory security with no critical vulnerabilities.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/30/2024
3 months - 2
FDA Approval
8/15/2024
Other devices from Smart Soft Healthcare
- CoLumbo2022 • 510K
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