(87 days)
The RPS-50 is intended to be used as an accessory to a linear accelerator under the direct control of a qualified individual (usually a therapeutic radiation physicist.) The scanner may be used for acceptance testing of new accelerators, quality control of existing accelerators, or for the collection of data necessary for the operation of a computerized treatment planning system.
The RPS-50 scanner consists of a water tank, linear scanning guides, electronic control of movement, chamber bias, and system gain control. A software program controls all movements and necessary electronic signals. The scanner moves a radiation detector through a field of high radiation and presents the collected data as a plot on a computer screen, as a table of data or on a floppy disk suitable for use in a treatment planning system.
This document describes a medical device, the RPS-50 Beam Scanner, which is a beam scanner for clinical linear accelerators. However, the provided text does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is absent in the input.
The input primarily provides:
- Trade Name, Common Name, Classification, Class, and Predicate Device.
- A physical description of the device and its components.
- Its intended use.
- A brief statement on its technological characteristics in comparison to the predicate.
- Contact information for the preparer.
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PREMARKET NOTIFICATION [510(k)] SUMMARY
Trade Name: RPS-50 Beam Scanner
Common Name: Beam scanner for clinical linear accelerator
Classification Name and Number: None given
Class: Class II, accessory to a linear accelerator
Predicate: A.R.M. beam scanner: control number K933558
Description: The RPS-50 scanner consists of a water tank, linear scanning guides, electronic control of movement, chamber bias, and system gain control. A software program controls all movements and necessary electronic signals. The scanner moves a radiation detector through a field of high radiation and presents the collected data as a plot on a computer screen, as a table of data or on a floppy disk suitable for use in a treatment planning system.
Intended Use: The RPS-50 is intended to be used as an accessory to a linear accelerator under the direct control of a qualified individual (usually a therapeutic radiation physicist.) The scanner may be used for acceptance testing of new accelerators, quality control of existing accelerators, or for the collection of data necessary for the operation of a computerized treatment planning system.
Technological Characteristics: The technological characteristics of the RPS-50 scanner and the predicate device are the same in that both are meant to collect beam data descriptive of the accelerator scanned. The data for both devices is evaluated by a clinical physicist for completeness and accuracy.
Prepared by: Jack C. Sofield, President Sofield Science Services, Inc. Seymour, TN 37865-5017 Tel. 423 573 1795; Fax. 423 577 8713 Date: Mav 21, 1996
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