(28 days)
The Varian Millennium 120 Multileaf Collimator (MLC) is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In a static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either Clinac® dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.
The Varian Millennium Multileaf Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac® radiation therapy linear accelerator beneath the standard field defining the collimator jaw.
This 510(k) premarket notification for the Varian Millennium MLC-120 Multileaf Collimator does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
This document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, as required by the FDA. It primarily addresses the device's technical characteristics, intended use, and comparison to an existing device.
Here's why the requested information is not present:
- Acceptance Criteria and Reported Device Performance: This document states: "See the attached 'Specification Comparison Chart' (Tab F)." This chart, which would likely contain acceptance criteria and performance data, is not provided in the given text.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Size, Training Set Ground Truth: These details would typically be found in a clinical study report or a detailed performance validation document, which are not included in this 510(k) summary. A 510(k) summary generally focuses on comparing the new device to a predicate device rather than presenting a full clinical trial report with these granular details.
Therefore,Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details.
§ 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.