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Accusoft-XL v.4.04 / CrossPlan 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 radiation therapy.

CrossPlan / AccuSoft-XL v. 4.04 is an upgraded version of the Company's proprietary AccuSoft-XL. CrossPlan / AccuSoft-XL v. 4.04 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. CrossPlan / AccuSoft-XL v. 4.04 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. CrossPlan / AccuSoft-XL v. 4.04 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 As an option, some of the data can be imported via DICOM server that will include information of RT objects (RT Plan, RT Structure Set, RT Images) and CT Images. CrossPlan / AccuSoft-XL v. 4.04 is able to combine two registered images to create a fusion image. This is often used to combine two images acquired differently but from a single source to enhance the display of various materials or tissues.

The provided text describes a 510(k) premarket notification for a radiation treatment planning system (RTPS) called AccuSoft-XL v. 4.04 (also marketed as CrossPlan). However, it does not contain the specific information required to complete the detailed breakdown of acceptance criteria and a study proving device performance as requested.

Here's why and what information is missing:

• Acceptance Criteria and Reported Performance Table (Item 1): The document lists voluntary standards that the device complies with (IEC 60601-1-4, FDA guidances), but these are general guidelines for software in medical devices, not specific performance acceptance criteria for dose computation or a comparative table of measured performance against those criteria.
• Study Details (Items 2-7): The text mentions "performance validation" and "performance testing" but provides no details on any specific study, including sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
• Training Set Details (Items 8-9): Information about the training set size or how its ground truth was established is completely absent.

Conclusion:

Based on the provided text, it is not possible to fill in the requested table and answer the questions about the study that proves the device meets acceptance criteria. The document focuses on regulatory compliance through substantial equivalence to predicate devices and adherence to general software standards, rather than detailing a specific performance validation study with quantitative acceptance criteria.

To answer your request, such a study would typically be detailed in a separate section of the 510(k) submission, often under "Performance Data" or "Clinical Performance," which is not present in the provided "510(k) Summary."

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