(51 days)
Indications For use: XKnife 5 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Radionics XKnife 5. It does not contain specific details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment that would be required to answer your questions.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device was cleared based on substantial equivalence to a predicate device, rather than a de novo clinical trial demonstrating performance against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given document. To obtain this kind of detailed information, you would typically need to refer to:
- The 510(k) submission summary itself (which is often publicly available on the FDA website).
- Clinical study reports, if any were performed and submitted.
- The device's Instruction for Use (IFU) or technical specifications.
§ 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.