Axial3D Insight
Axial Medical Printing LimitedAxial3D Insight is a cloud-based service that processes medical imaging DICOM data to create detailed 3D digital files or physical 3D printed models. These models assist clinicians in treatment planning and diagnosis across orthopedic trauma, maxillofacial, and cardiovascular applications, improving surgical preparation and outcomes.
Intended Use
Axial3D Insight is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file. The output file or physical replica can be used for treatment planning and diagnostic purposes in orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications.
Technology
Axial3D Insight is a cloud-based image processing, segmentation, and 3D modeling framework that outputs digital files used for 3D printing patient-specific replicas. It leverages a combination of automated segmentation tools with smart editing, validated machine learning models, and supports CT and CTA images.
Performance
The device underwent software design verification and validation according to FDA guidance for moderate risk software. Clinical segmentation performance was validated with radiologist review of 12 cases. Intended use validation was conducted with 9 physicians reviewing cases across orthopedics, trauma, maxillofacial, and cardiovascular fields. The machine learning models used for initial segmentation were independently validated on thousands of CT images from multiple manufacturers.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/12/2022
9 months - 2
FDA Approval
7/3/2023
Other devices from Axial Medical Printing Limited
- Axial3D Insight2023 • 510K
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