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segmentation assistant for prostate-auto contouring
Omisa Inc. (Segasist Technologies)
Summary: The segmentation assistant for prostate-auto contouring by Omisa Inc. is designed to aid in the automatic delineation of the prostate for radiotherapy planning. Key evidence highlights its utility in reducing manual editing time during treatment planning.
FDA Clearance Information
Pathway
510K
Number
K111311 ↗
Decision Date
October 17, 2011
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on October 17, 2011. It is manufactured by Omisa Inc. and classified as a Class 2 device under product code MUJ.
What It Is
The segmentation assistant is a software tool that automatically contours the prostate in imaging studies, primarily used in radiotherapy planning. It leverages deep learning algorithms to enhance the precision and efficiency of treatment planning.
Clinical Applications
Commonly used in radiotherapy settings, this device assists in the accurate delineation of the prostate, reducing the need for manual contouring and potentially improving treatment accuracy and efficiency.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and retrospective analyses, published between 2023 and 2024. These studies evaluate the device's effectiveness and applicability in clinical settings.
Reported Outcomes
Published studies report that the device effectively reduces the time required for manual editing of prostate contours in radiotherapy planning. It enhances the precision of contouring, which is crucial for accurate dose delivery in prostate cancer treatment.
Safety Profile
Reported complications include potential inaccuracies in auto-segmentation that may require manual correction, which could prolong treatment planning time. However, no significant adverse events directly attributed to the device were noted.
Evidence Limitations
Current evidence highlights the need for standardized assessment metrics for auto-contouring systems. Further research is needed to validate the device's performance across diverse clinical settings and imaging modalities.
Frequently Asked Questions
What are the clinical indications for the segmentation assistant for prostate-auto contouring?
The device is indicated for use in radiotherapy planning to automatically contour the prostate, aiding in precise treatment delivery.
What outcomes have been reported in clinical studies?
Studies report improved efficiency in treatment planning and reduced manual editing time, enhancing the precision of prostate contouring.
What complications have been reported?
Safety data indicate potential inaccuracies in auto-segmentation requiring manual correction, but no significant adverse events have been directly linked to the device.
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.