(88 days)
Not Found
The PORTpro is a free-standing, digital camera based electronic portal imaging device (EPID) for use as an accessory to existing x-radiation therapy systems operating in the megavoltage range (1 - 15 MeV). The PORTpro displays high quality portal images on a computer monitor in virtually real time and also provides archiving and image processing capabilities.
This document describes the PORTpro Electronic Portal Imaging System, a device used as an accessory to x-radiation therapy systems. However, the provided text does not contain any information regarding acceptance criteria, studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is missing from the provided input.
The document primarily focuses on the device's description, its predicate devices, and a comparison of its technological characteristics. It mentions that "The differences between the systems raise no new issues of safety or effectiveness," but does not provide any data or studies to support this claim or any other performance claim.
§ 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.