Axial3D Insight
Axial Medical Printing LimitedAxial3D Insight is a cloud-based image segmentation and 3D modeling service that converts medical imaging data into digital files or 3D printed physical models. These outputs assist clinicians in treatment planning and diagnosis for trauma, orthopedic, maxillofacial, and cardiovascular conditions, improving clinical decision-making.
Intended Use
Cloud-based service and image segmentation framework for transfer of DICOM imaging information to output file or physical replica, for treatment planning and diagnostic purposes in trauma, orthopedic, maxillofacial, and cardiovascular fields.
Technology
A secure cloud-based framework performing image processing, segmentation, and 3D modeling from DICOM images resulting in 3D digital files or 3D printed physical replicas. Supports CT/CTA data, includes automated tools with smart editing, and validated with multiple clinical fields. Compatible with various 3D printers and materials.
Performance
Performance validated through software design verification and validation following FDA guidance for moderate risk software. Clinical segmentation performance and intended use validation studies conducted with radiologists and physicians across orthopedics, trauma, maxillofacial, and cardiovascular cases yielding acceptable assessment scores. Machine learning models independently verified. Phantom testing demonstrated 3D printer accuracy within ±0.3 mm, consistent with predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/14/2023
2 months - 2
FDA Approval
11/15/2023
Other devices from Axial Medical Printing Limited
- Axial3D Insight2023 • 510K
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