(210 days)
The indications for use of pReference Treatment Planning Software 1.1 are such intracranial diseases as gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas.
The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Not Found
This is a 510(k) clearance letter and an Indications for Use statement for the "pReference Treatment Planning Software 1.1". These documents confirm the device's clearance for marketing based on substantial equivalence to a predicate device, but they do not contain information about acceptance criteria or specific study details proving the device meets those criteria, nor do they include performance metrics like those typically found in a clinical study report.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a clinical study report, a validation report, or a similar performance evaluation document for the pReference Treatment Planning Software 1.1.
§ 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.