(27 days)
XPlan 2.2 software is a stereotactic LINAC-based ration treatment planning system. XPlan 2.2 with the Body System localizes lesions to be treated using CT scans, MR scans, and digitized anglographic film. XPlan 2.2 with the Body System provides stereotactic planning system for treatment of tumors. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.
The above system consists of stereotactic treatment planning software and hardware to immobilize and localize the patient.
No information about acceptance criteria or a study proving the device meets said criteria can be found in the provided text. The document is a 510(k) summary for a medical device (Radionics XPlan 2.2 with the Body System) and an FDA clearance letter. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's intended use and regulatory classification. There is no mention of specific performance metrics, clinical studies, or data used to validate the device's accuracy or efficacy.
§ 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.