đź“Š Evidence-Based Reference
modification to cyberknife robotic radiosurgery system
Accuray
Summary: The CyberKnife Robotic Radiosurgery System is a non-invasive treatment device for delivering precise radiation therapy. It is primarily used for stereotactic radiosurgery in various cancers. Key evidence highlights its surgical precision and submillimeter accuracy.
FDA Clearance Information
Pathway
510K
Number
K091146 ↗
Decision Date
May 1, 2009
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The CyberKnife Robotic Radiosurgery System by Accuray was cleared by the FDA via the 510(k) pathway on May 1, 2009. It is classified as a Class 2 device under product code MUJ.
What It Is
The CyberKnife is a robotic radiosurgery system that uses a compact linear accelerator mounted on a robotic arm to deliver high-dose radiation with precision. It is intended for the treatment of tumors and lesions in various parts of the body, offering a non-invasive alternative to traditional surgery.
Clinical Applications
Common clinical scenarios for the CyberKnife include treatment of brain metastases, early-stage breast cancer, and renal cancer. It is particularly useful in cases where conventional surgery is not feasible or poses significant risks.
Evidence Summary
The available literature includes a mix of retrospective and prospective studies, with a total of 6 studies identified. These studies span from 2008 to recent years, highlighting the system's precision and application in various cancers.
Reported Outcomes
Published studies report that the CyberKnife system achieves surgical precision in radiation delivery, with submillimeter accuracy confirmed through quality assurance techniques. It has been used effectively in treating neurinomas, breast cancer, and brain metastases, demonstrating its versatility and efficacy.
Safety Profile
Reported complications include the need for rigorous quality assurance due to the system's complexity. No specific adverse events are detailed in the provided evidence, but the importance of precise calibration and monitoring is emphasized.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials and long-term follow-up data. Further research is needed to establish comprehensive safety profiles and long-term efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for CyberKnife Robotic Radiosurgery System?
The CyberKnife is indicated for the treatment of tumors and lesions in various parts of the body, including brain metastases, early-stage breast cancer, and renal cancer.
What outcomes have been reported in clinical studies?
Studies report high precision in radiation delivery with submillimeter accuracy, effective treatment of neurinomas, breast cancer, and brain metastases.
What complications have been reported?
Reported complications include the necessity for rigorous quality assurance due to system complexity, with no specific adverse events detailed in the provided evidence.
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.