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Smart Segmentation Knowledge Based Contouring
Summary: Smart segmentation knowledge based contouring is a device used for automated contouring in medical imaging. It is primarily used in radiation therapy planning. Key evidence highlights its efficacy in delineating anatomical structures with high accuracy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K141248 ↗
Decision Date ?
September 5, 2014
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on September 5, 2014. It is manufactured by Varian Medical Systems and classified as a Class 2 device under product code MUJ.
What It Is
The smart segmentation knowledge based contouring device utilizes advanced algorithms to automate the contouring process in medical imaging. It is designed to enhance precision in delineating anatomical structures, particularly in radiation therapy planning.
FDA-Cleared Indications
- For computer-assisted identification and delineation of anatomical structures in medical images.
- For use as part of radiation therapy treatment planning under the supervision of qualified healthcare professionals.
- The generated contours are intended to be reviewed and edited by the clinician before clinical use.
Clinical Applications
- Contouring organs at risk during radiation therapy planning.
- Delineating target volumes and other anatomical structures on treatment-planning images.
- Supporting review and modification of radiation therapy contours by qualified clinicians.
- Reducing manual contouring time and variability in image-guided treatment planning.
Evidence Summary
The available literature includes three studies, with publication years ranging from 2019 to 2021. These studies encompass various methodologies, including retrospective and prospective analyses, focusing on the efficacy of automated segmentation techniques.
Reported Outcomes
Published studies report that the smart segmentation method achieves a mean Dice Similarity Coefficient (DSC) of 0.964, indicating high accuracy in anatomical delineation. Comparatively, 2D and 3D U-Net methods reported slightly higher DSC values, suggesting competitive performance in specific contexts.
Safety Profile
Reported complications include no specific adverse events directly linked to the device in the provided studies. The safety profile appears favorable, with no significant complications noted in the literature.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of diverse clinical settings. Further research is needed to validate the device's efficacy across different patient populations and anatomical regions.
Practical Considerations
- This is software rather than an implantable or disposable device, so it does not have a physical device size or indwelling duration.
- Contours are algorithm-generated and require clinician review, correction, and approval before treatment planning or delivery.
- Performance can vary with imaging quality, anatomy, patient positioning, pathology, and the imaging dataset used.
- The software is intended for use within a compatible radiation therapy planning and medical-imaging workflow; compatibility should be confirmed with the installed system and software version.
- MRI safety considerations apply to the MRI scanner and associated hardware, not to the contouring software itself. The software does not make an MRI environment safe for patients or equipment.
Frequently Asked Questions
What are the clinical indications for smart segmentation knowledge based contouring?
The device is indicated for use in radiation therapy planning, where precise anatomical delineation is critical.
What outcomes have been reported in clinical studies?
Studies report high accuracy in anatomical delineation, with a mean DSC of 0.964 for the smart segmentation method.
What complications have been reported?
Reported complications include no significant adverse events directly associated with the device in the available studies.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.