PhantomMSK Trauma
OrthoGrid Systems Inc.PhantomMSK Trauma is a software tool that helps surgeons during orthopedic trauma surgeries by providing precise measurements and image analysis of fluoroscopic images. It assists in the intraoperative positioning of implants relative to bone structures, helping improve surgical accuracy without primary image interpretation.
Intended Use
PhantomMSK Trauma is an image-processing software indicated to assist in the positioning of Orthopedic Trauma components intraoperatively by measuring their positions relative to bone structures identifiable from radiology images. It is not for primary image interpretation and requires clinical judgment.
Technology
PhantomMSK Trauma is non-invasive image processing software that analyzes fluoroscopic images acquired from a C-arm. It provides templating, measurement, and distortion correction tools. The system uses a radiopaque calibration array attached to the C-arm image intensifier to calculate and correct fluoroscopic distortion, and operates on standard PC hardware.
Performance
Verification and validation testing were conducted at code and system levels following pre-established test protocols, ensuring the templating, measurement, and distortion correction functions perform as expected. Testing included compatibility with GE OEC 9900 and 9800 C-arms and various image intensifier sizes. Results met acceptability criteria for software release.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/22/2019
3 months - 2
FDA Approval
12/7/2019
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.