(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 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 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, Xsight™ spine tracking, Synchrony" Respiratory Tracking and Lung Tumor Tracking for dynamic positioning and pointing of the linear accelerator.
The provided text is a 510(k) summary for the CyberKnife® Robotic Radiosurgery System. However, it does not contain the detailed acceptance criteria or the study results that prove the device meets these criteria. The document focuses on the device description, intended use, and substantial equivalence to a predicate device, which are standard components of a 510(k) summary for regulatory approval.
Specifically, the excerpt is missing information regarding:
- Quantitative acceptance criteria (e.g., accuracy, precision targets).
- Details of any specific performance studies, including sample sizes, data provenance, expert ground truth, or statistical results.
- Information on MRMC studies or standalone algorithm performance.
Therefore, I cannot populate the table or answer the specific questions based solely on the text provided. The document states that "The CyberKnife Robotic Radiosurgery System with the Lung Tumor 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 device is deemed acceptable because it performs similarly to an already approved device, rather than by meeting a specific set of new, quantitative acceptance criteria outlined in this summary.
To answer your request, I would need a different document that details the performance studies and their 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.