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The Varian High-Definition 120 Multileaf Collimator (HD120 MLC) is an accessory X-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape the X-ray field perimeter. Field shape can be either static (fixed) or dynamic. Dynamic field shapes are controlled as a function of the accelerator dose fraction or gantry angle. The intended use is to assist the clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

The Varian High-Definition120 Multileaf Collimator (HD120 MLC) is provided to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

The High-Definition 120 Multileaf Collimator (HD120 MLC) provides higher resolution via finer width leaves in the center section of the treatment field. The total number of leaves remains the same at 120. As a result of the finer leaves, the treatment field has been modified from 40 cm in width. The length of the treatment field remains unchanged.

The objective of the area occupied by the finer leaves is to provide for higher definition shaping of treatment fields. These fields are primarily directed at small targets during single fraction Stereotactic Radiosurgery (SRS) and multi-fraction Stereotactic Radiotherapy (SRT).

The provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The document is a 510(k) summary for the High-Definition 120 Multileaf Collimator (HD120 MLC), primarily focusing on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, it is not possible to complete the requested table and information based on the provided text.

Specifically, the document discusses:

• Device Description: The HD120 MLC provides higher resolution via finer width leaves for shaping treatment fields, primarily for small targets during SRS and SRT.
• Intended Use: To assist clinicians in delivering radiation to defined target volumes while sparing surrounding normal tissue and critical organs.
• Substantial Equivalence: It claims substantial equivalence to the Varian Medical Systems Millennium Multileaf Collimator (K050442). This typically means that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, they do not raise new questions of safety or effectiveness.

Without explicit performance testing data, acceptance criteria, sample sizes, ground truth establishment, or expert involvement details, the requested information cannot be extracted.

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