Search Results

The CyberKnife® Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The CyberKnife® Treatment Delivery System may be used to treat astrocytoma, glioma, skull base tumors, metastases (brain and bony), nasopharyngeal carcinoma, meningioma, acoustic neuroma, schwannoma, pituitary adenoma, hemangioblastoma, craniopharngioma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, and tumors of the neck, spine, pancreas, liver, lungs, ovary, prostate, and bladder. Patients should be examined by a team of physicians to determine if they are candidates for CyberKnife treatment.

The CyberKnife® Treatment Delivery System (CKTDS), subject of this submission, is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision™ Treatment Planning System (K161136) and iDMS™ Data Management System (K161144).

The CKTDS uses a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem of the treatment delivery system provides X-rays of the treatment area that lets the user know the position of the target. The CyberKnife® Treatment Delivery System uses skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Tracking for dynamic positioning and pointing of the linear accelerator. The fixed aperture, variable aperture, and multileaf collimators are available as various beam-limiting secondary collimators.

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them, as outlined in your request. The document is a 510(k) summary for the CyberKnife® Treatment Delivery System, which primarily focuses on establishing substantial equivalence to a predicate device.

Specifically, it lacks:

• A table of acceptance criteria and reported device performance. While it states "Testing was done to verify that all hardware and software perform as designed" and "The results from testing included in the premarket notification demonstrate that subject device performance characteristics are equivalent to the treatment delivery component of the predicate device," it does not provide specific acceptance criteria or quantitative performance data.
• Sample sizes used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily states that the CyberKnife® Treatment Delivery System is substantially equivalent to the treatment delivery component of the predicate, CyberKnife M6 Systems (cleared under K150873), based on shared intended use, principles of operation, technological characteristics, design, materials, and physical properties. It mentions "regressing testing" was performed to verify existing features, but no details of this testing are provided.

Ask a specific question about this device