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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.
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SUMMARY OF SAFETY AND EFFECTIVENE
i his summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
FEB - 4 1997
Submitter:
Eliav Ltd., POB 10403, Haifa 26115, Israel Tel: +972.4.842.1541 Fax: +972.2.841.1129
Name of the Device: PORTpro Electronic Portal Imaging System
Predicate Devices: The PORTpro is substantially equivalent to a combination of the SRI 100 Radiotherapy Imaging System manufactured by Phillips Medical Systems and the Huestis Flexi-Holder manufactured by Huestis Medical Products.
Description of the Device: 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. The real time display of images is advantageous insofar as treating physicians and therapy technicians are able to quickly produce position verification images without time consuming set up and development of radiographic films. This is helpful in radiation therapy since frequent monitoring of patient positioning can reduce the frequency of discrepancies in (x-ray) field placement. and improve geometric accuracy of the treatments.
Because the PORTpro has a free-standing detector support system, it offers advantages over other EPID's without this feature, i.e., easy positioning of the imaging system, adjustable and relatively large effective field of view, and the ability to do "non-couch" total body irradiation (TBI) and total lymphatic irradiation (TLI).
| TechnologicalCharacteristic | PORTpro | SRI 100 | Flexi-holder |
|---|---|---|---|
| Acquisition regime | Full field | Full field | NA |
| Acquisition matrix | 746 x 582 | 512 x 256 | NA |
| Spatial resolution | 1.0 mm | 2.0 mm | NA |
| Pixel resolution (bits) | 16 | 16 | NA |
| High Voltage | No | No | No |
| CCD/Video | CCD | CCD | NA |
| Height | 75" | NA | 75" |
| Weight | 136 lbs. | ----- | 110 lbs. |
| Base | 14" x 30" | NA | 19" x 22" |
Comparison of Technological Characteristics:
The differences between the systems raise no new issues of safety or effectiveness.
Date
Mr. Reuven Levinson, President
N/A