(78 days)
The CyberKnife VSI™ Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.
The CyberKnife VSI Robotic Radiosurgery System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife VSI uses skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.
The provided text describes a 510(k) summary for the CyberKnife VSI™ Robotic Radiosurgery System. However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details typically found in such a study (sample size, expert qualifications, ground truth methodology, MRMC study, or standalone performance results).
The document is a submission for substantial equivalence to a predicate device, focusing on the device's description, intended use, and substantial equivalence claim. It explicitly states: "The CyberKnife VSI is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same or equivalent."
Therefore, I cannot extract the requested information from the provided text.
To answer your request, I would need a different document that details the performance study conducted for the CyberKnife VSI™ Robotic Radiosurgery System, including the acceptance criteria and results.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.