(88 days)
The Dynamic Wedge system is intended to be used with MLC and Mitsubishi linear accelerators with computerized consoles to provide the effective isodose curve and replace the need for traditional hard wedges.
This submission is intended to be applicable to the Dynamic Wedge system which can be used with multileaf collimator system on Mitsubishi linear accelerators for external beam radiotherapy. The Dynamic Wedge system is designed to create effective isodose curve by using collimator leaf drive during irradiation. The Dynamic Wedge system consists of the collimator, motor drive unit (MDU), local control equipment (LCE) located in the treatment room, control console, and data management equipment (DME).
The collimator consists of two sets of jaws which determines the field size and shape. The upper jaws consist of a pair of monoblocks just like conventional accelerator therapy collimators. The upper jaws move in tandem and determine the field length.
The lower set of jaws consist of 31 pairs of leaves (62 leaves).
Each pair of leaves is independently driven by a stepping motor. Each pair of leaves can be independently set to provide irregular-shaped field settings.
The provided text is a 510(k) summary for a medical device (Mitsubishi Linear Accelerators EXL Series, specifically the Dynamic Wedge system). This document focuses on the technical description and intended use of the device, and discusses its substantial equivalence to a predicate device for regulatory purposes.
It does not contain information about acceptance criteria, performance studies, or ground truth establishment as would be present in a clinical validation study. Therefore, I cannot extract the requested information from the provided text.
To provide the requested details, I would need a document specifically detailing the clinical performance evaluation of the Dynamic Wedge system.
§ 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.