MRI Planner
Spectronic Medical ABMRI Planner is a software tool for radiation oncologists and medical physicists that uses MRI images to help plan radiotherapy treatments. It generates synthetic CT images and automatically outlines certain healthy anatomical structures to assist in treatment planning, particularly for cancers in the brain, head-neck, and pelvic regions. This helps improve the accuracy and efficiency of radiotherapy planning without manually contouring from scratch.
Intended Use
MRI Planner is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to process MRI images to provide information for radiation attenuation estimation and to assist in localization/definition of healthy anatomical structures for radiotherapy treatment planning, for adult patients with primary and metastatic cancers in brain, head-neck, and pelvic regions. It generates synthetic CT images and automatically derived contours of bladder, colon and femoral heads for prostate cancer patients only.
Technology
MRI Planner uses pre-trained machine learning models to convert MRI images into synthetic CT images and to automatically generate contours of anatomical structures (bladder, colon, femoral heads) for prostate cancer patients. The models were trained on datasets of MRI and CT images acquired in treatment positions at multiple hospitals. Software runs on standard x86-64 systems with CUDA-capable NVIDIA GPU and Ubuntu Linux.
Performance
Bench testing demonstrated dosimetric equivalence between MRI Planner generated synthetic CT and conventional CT using dose difference and gamma evaluation metrics across pelvis, brain, and head-neck regions. Auto-contouring accuracy was evaluated using Dice scores and Hausdorff distances comparing automatically generated contours to manual delineations for prostate cancer. The device meets acceptance criteria and complies with multiple FDA recognized standards. Bench tests confirm safety and effectiveness comparable to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/14/2021
1 year, 2 months - 2
FDA Approval
8/25/2022
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