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The MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics XPlan Conformal Treatment Planning Software on any treatment planning system, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. In this application, the MMLC performs the same function as customized beam shaping blocks, and circular or cut block collimators, which have been used for many years.

The MMLC is a conformal radiation therapy and radiosurgery device. The MMLC is mounted to a standard radiation therapy LINAC and is capable of shaping the x-ray field (maximum field treatment of 10 cm x 12 cm). A stand-alone computer controls the MMLC unit. The computer communicates with the MMLC to position the leaves according to the treatment plan. An individual motor controls each leaf. Power to the motors and electronics is provided by a switching power supply.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the Radionics Mini Multi-Leaf Collimator (MMLC). It outlines:

• Proprietary and common names, product code, and classification.
• A general summary of safety and effectiveness.
• Mentions that no applicable performance standards have been issued by the FDA, but lists voluntary standards (EN55011, EN 60601-1-2, EN 60601-1, UL 2601) related to electromagnetic compatibility and electrical safety. These are not performance criteria for the device's therapeutic function.
• Establishment registration details.
• Predicate device (Brainlab Micro Multi-Leaf Collimator K970586).
• Indications for Use, describing the MMLC's purpose in radiation therapy.
• Device characteristics, detailing its mechanism and operation.
• An official FDA letter confirming substantial equivalence to a predicate device.

To answer your request, information regarding specific performance acceptance criteria (e.g., leaf positioning accuracy, dose conformity, mechanical stability tolerances) and studies (e.g., phantom studies, dosimetric measurements, clinical trials) conducted to demonstrate compliance would be required. This type of information is typically found in the full 510(k) submission or internal company documentation, not usually in the publicly available summary for this type of device.

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