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The NOMOS Slit Collimator (BEAK™) is intended for use in Radiosurgery/Radiation Therapy to secondarily collimate the width of the radiation beam after it passes through the MIMiC® Multileaf Intensity Modulating Collimator (K940412). Several sizes of collimators will be provided with a slit width, at isocenter, ranging from 1 mm to 8 mm.

The Slit Collimator (BEAK) is tungsten block whose purpose is to provide secondary collimation for the radiation beam exiting from the NOMOS MIMiC (K940412). The MIMiC has the capability of delivering treatment slices whose width is either 8 mm or 16 mm. The Slit collimator, by providing secondary collimation of the 8 mm beam, allows slices to be delivered that are 1 - 8 mm in thickness without the need to modify the control mechanisms built into the MIMiC that ensure that leaf (vane) movement is functioning correctly. In this sense, the Slit Collimator serves the same purpose as the secondary collimators provided with radiosurgical systems or the secondary collimators, commonly called blocks, that are used with radiation therapy linear accelerators.

This document does not contain a description of acceptance criteria or a study proving device performance against such criteria. The provided text is a 510(k) summary for the NOMOS Slit Collimator (BEAK™), which focuses on demonstrating substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria.

Therefore, I cannot populate the table or answer the questions as the required information is not present in the provided text. The document primarily describes the device, its intended use, and argues for its substantial equivalence to existing devices based on design, materials, and intended purpose without detailing specific performance metrics or clinical study results.

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