SpineUs™ System
Verdure ImagingThe SpineUs™ System by Verdure Imaging is a diagnostic ultrasound platform designed to help trained chiropractors and radiologists acquire, view, segment, and measure spinal ultrasound images. It uses AI technology to automatically segment vertebral bone structures and provides 3D reconstructions and quantitative measurements such as intervertebral angles and spine curvature, aiding clinical evaluation of the spine in both hospital and clinic settings.
Intended Use
The SpineUs™ system is a software-based, tracked, ultrasound imaging system intended for diagnostic ultrasound imaging of the musculoskeletal system, specifically for imaging the spine, and intended for use by trained chiropractors and radiologists in hospital or medical clinic settings.
Technology
The system integrates an FDA-cleared Clarius Ultrasound Scanner (model C3 HD3), a consumer PC with SpineUs™ computer application, and a tracking system utilizing OptiTrack cameras and active LED markers. The AI-based software segments vertebral bone surfaces from ultrasound images in real-time, reconstructs 3D spine surface models, measures anatomical components such as intervertebral angles and curvature, and manages patient data.
Performance
Performance testing included standalone AI segmentation validation using a development dataset of 17684 ultrasound images from 45 patients and clinical testing comparing scoliosis angle measurements using SpineUs™ to X-ray-based measurements for 31 patients. The AI achieved 100% identification of transverse processes and processed images at 140 frames per second. Clinical angle measurement error compared to X-ray averaged 2.81 degrees. The system demonstrated compliance with key medical device safety standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/15/2024
5 months - 2
FDA Approval
10/7/2024
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