O-arm O2 Imaging System
Medtronic Navigation, IncThe O-arm O2 Imaging System by Medtronic Navigation, Inc is a mobile X-ray device designed to provide detailed 2D and 3D imaging of patients' bony anatomy and metallic objects, mainly used during image-guided surgeries. It includes advanced software features such as metal artifact reduction and dose reduction using machine learning, helping clinicians obtain clearer images with lower radiation exposure for improved surgical navigation and patient safety.
Intended Use
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D and 3D imaging of adult and pediatric patients (≥60 lbs and abdominal thickness >16 cm), providing detailed information on anatomic structures and highly attenuating objects like bone and metallic implants, compatible with image-guided surgery systems.
Technology
The system consists of an Image Acquisition System with motorized gantry and X-ray tank powered by internal batteries, and a Mobile View Station. It uses cone-beam CT for 3D image reconstruction through a 360-degree gantry rotation. Key software updates include Medtronic Implant Resolution (metal artifact reduction via known-geometry algorithms), 3D Long Scan for extended spinal imaging, and Spine Smart Dose, a machine learning algorithm reducing 3D scan noise at approximately 70% radiation dose reduction.
Performance
Performance testing included clinical equivalence studies by board-certified radiologists, bench testing of image quality and navigation accuracy, dosimetry confirming radiation dose reductions, and usability validations. The newly introduced software features Spine Smart Dose and Known-Component Metal Artifact Reduction (KCMAR) demonstrated statistically equivalent or superior image quality compared to the predicate, with substantial dose reduction and improved artifact suppression.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/16/2024
4 months - 2
FDA Approval
6/21/2024
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