(234 days)
The primary function of MLC Fit is to provide a means to define multileaf collimator leaf plans based on a user defined shape of a desired treatment area for use with a cancer radiotherapy treatment machines equipped with a multileaf collimator manufactured by Siemens Medical Systems and Varian Associates. Users may create, view, and edit MLC leaf data as well as other geometric parameters associated with treatment field definitions. An intended use statement for MLC Fit is contained in Exhibit 2a of this submission.
The goal of MLC Fit is to provide the leaf positions for a given treatment shape in a manner that eliminates the slow and error prone method of hand calculating the position for each leaf and manually setting up the leaf plans. MLC Fit allows the users to define treatment field shapes and generate multileaf collimator leaf plans based on that input shape. Leaf positions and other geometric parameters can be adjusted to meet the user's clinical requirements. MLC Fit is not capable of moving the leaves or other parameters to the calculated positions; it only provides the definition of the treatment field as a hardcopy and to a database file.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document describes the function and development process of "MLC Fit," a software designed to define multileaf collimator leaf plans for cancer radiotherapy. It focuses on the software's purpose, its development according to internal standards, and hazard analysis.
Therefore, I cannot provide the requested information.
§ 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.