(31 days)
The CyberKnife® 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 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 System uses skull tracking, fiducial tracking and skeletal structure tracking for dynamic positioning and pointing of the linear accelerator.
The provided 510(k) summary (K062514) for the CyberKnife® Robotic Radiosurgery System does not contain the detailed information required for a comprehensive description of acceptance criteria and the study proving device performance.
This document is a 510(k) Summary, which is a high-level overview submitted to the FDA to demonstrate substantial equivalence to a predicate device. It typically focuses on the device's intended use, technological characteristics, and comparison to the predicate, rather than detailed performance studies and acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, details about MRMC or standalone studies, or ground truth information based solely on the provided text.
The document states: "The CyberKnife Robotic Radiosurgery System with the modified Fiducial Tracking algorithm is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same or equivalent." This statement implies that the modifications to the fiducial tracking algorithm were deemed to not raise new questions of safety and effectiveness, and therefore, extensive new clinical performance studies might not have been required for this specific submission as part of proving substantial equivalence.
To answer your request thoroughly, I would need access to the full 510(k) submission or supporting technical documentation referenced within it, which would typically contain the details of validation studies.
§ 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.