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AccuSoft-XL is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radia fon therapy.

AccuSoft-XL is a radiation treatment planning system (RTPS), consisting of a collection of software modules that execute algorithms to produce estimates of beam radiation dose distribution in body tissues. It includes the image, delineation and beam planning techniques. AccuSoft-XL is an upgraded version of the Company's proprietary AccuSoft v3.14. It is designed to operate with Cones, Blocks and Wedges, as well as with a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular, shape of the lesion. The ability to shape the radiation beam enables maximization of the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures. AccuSoft-XL is used for computation, display, evaluation, and output of dose estimations, including those for several modes of treatment, such as Conformal, Blocks and Wedges, Cones and Intensity Modulated Radiation Therapy (IMRT). There are several IMRT treatment modes: (1) Intensity Modulated Arc Therapy (IMAT) – in which an irradiating Linac rotates while leaves form a sequence of apertures (arcs), (2) Dynamic Intensity Modulated Radiation Therapy (DIMRT) – in which irradiating Linac is stationary while leaves form a sequence of apertures, as well as (3) Intensity Modulated Radiation Therapy (also called Step-and-Shoot), during which apertures are formed prior to irradiation The Linac and Cones / MMLC configuration parameters shall be written to a file to be sent to both the Linac and the Company's proprietary Cone Changer / MMLC devices. In the AccuFusion module, AccuSoft-XL combines two different types of axial images. This enables to enhance the display of various materials or tissues and to perform target delineation on fused images. Thus, CT images and Secondary Images (CT, MRI, PET, etc.) in DIOOM format from the same patient can be combined, resulting in an improved single image.

The provided document (K062032) is a 510(k) summary for the AccuSoft-XL radiation treatment planning system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or detailed study results proving the device meets acceptance criteria.

The document states:

• "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act."
• "Based on validations and performance testing results, Direx Systems Corp. believes that AccuSoft-XL is substantially equivalent to the above predicate devices without raising new safety and/or effective use issues." (This implies that testing was done, but the results are not detailed here).

Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically does not include the detailed testing protocols and results that would be found in the full 510(k) submission.

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