Spine Auto Views
GE Medical Systems SCSSpine Auto Views is a software tool that automatically processes CT images of the spine to create anatomically focused reformatted views and labels vertebrae and disc spaces, facilitating quick and consistent review for clinicians. It utilizes deep learning algorithms to generate multiple reformatted image planes without user interaction and exports the results automatically for radiologist reading.
Intended Use
Spine Auto Views is a non-invasive image analysis software package which may be used in conjunction with CT images to aid in the automatic generation of anatomically focused multi-planar reformats and automatically export results to pre-determined DICOM destinations.
Technology
Spine Auto Views employs a deep learning algorithm to automatically detect vertebral bodies and intervertebral discs, generating oblique axial, curved coronal, and curved sagittal reformatted images without manual interaction, and applies anatomical labels. The software exports generated series automatically to DICOM destinations. It uses a centerline traced through the posterior edge of discs to guide reformats.
Performance
Verification and validation testing under a quality system were performed, showing no new safety concerns. Clinical reader study showed greater than 95% user acceptance of spine automated reformats in oblique axial, curved coronal, and curved sagittal planes compared to manual standards. Algorithm validation confirmed accurate detection of intervertebral discs across representative CT exams.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/14/2022
8 months - 2
FDA Approval
7/13/2023
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