đź“Š Evidence-Based Reference
optical tracking system with surface matching module model ots
Radionics
Summary: The optical tracking system with surface matching module by Radionics is primarily used for precise tumor ablation procedures. Key evidence highlights its effectiveness in tracking patient surface contours during radiotherapy.
FDA Clearance Information
Pathway
510K
Number
K983669 ↗
Decision Date
November 18, 1998
Product Code
HAW
Device Class
Class 2
Evidence
0 studies
The optical tracking system was cleared by the FDA through the 510(k) pathway on November 18, 1998. It is manufactured by Radionics and classified as a Class 2 device.
What It Is
The optical tracking system is designed to track and match surface contours of patients during medical procedures, particularly in tumor ablation. It uses optical technology to provide real-time feedback on patient positioning.
Clinical Applications
Commonly used in radiotherapy and surgical procedures where precise tracking of patient surface is critical. It aids in accurate targeting and delivery of treatment to tumors.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and prospective analyses, published between 2023 and 2026. These studies evaluate the system's accuracy and performance in clinical settings.
Reported Outcomes
Published studies report that the optical tracking system provides high accuracy in tracking patient surface contours, improving the precision of radiotherapy and surgical interventions. It has been shown to perform well under different conditions, such as varying skin colors and lighting.
Safety Profile
Reported complications include minimal adverse events, primarily related to system calibration and environmental factors affecting tracking accuracy. No significant safety concerns have been identified in the reviewed studies.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to assess long-term outcomes and to validate findings in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the optical tracking system?
The device is indicated for use in procedures requiring precise surface tracking, such as tumor ablation and radiotherapy.
What outcomes have been reported in clinical studies?
Studies have reported high accuracy in surface tracking, enhancing the precision of treatment delivery in radiotherapy and surgery.
What complications have been reported?
Safety data indicate minimal complications, mainly related to calibration and environmental factors affecting tracking accuracy.
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.