Search Results

The CyberKnife® M6™ Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The CyberKnife M6 Systems are computer-controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. They use 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 provides X-rays of the treatment area that lets the user know the position of the target.

The CyberKnife M6 Systems use skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The fixed, variable aperture and multileaf collimators are available as various beam-limiting secondary collimators.

The provided text includes a 510(k) summary for the CyberKnife® M6™ Systems, which are medical devices for radiation therapy. However, this document does not contain specific acceptance criteria or the details of a study demonstrating that the device meets those criteria, as typically requested for AI/ML device evaluations.

The document highlights the device's intended use, its description, and a claim of substantial equivalence to a predicate device. It briefly mentions "Testing was done to verify that the all hardware and software perform as designed, as well as regression testing to verify integrity of existing features. The results from testing included in the premarket notification demonstrated that the performance characteristics of the device are equivalent to the predicate system."

This statement is very general and lacks the detailed information required to fill out your requested table and study information. Therefore, I cannot provide the requested details using only the provided text.

To be able to answer your questions, I would need a section of the 510(k) submission (or an accompanying document) that specifically details:

• Performance data: Specific metrics (e.g., accuracy, precision, sensitivity, specificity, agreement rates) with their defined acceptance thresholds.
• Study design: Information about a clinical validation study or other performance assessment.

Without this information, any attempt to fill out the table or answer the questions would be speculative and not based on the provided text.

Ask a specific question about this device