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WIN-NEUS ™ is planning system software for brain Stereotactic surgery such as biopsies and treatment of Parkinson disease. The WIN-NEUS ™ is intended to be used with Leksell Coordinate G Frame and Leksell Multi Purpose Stereotactic Arc systems.

WIN-NEUS ™ is planning system software for brain Stereotactic Surgery. The user can load image patient studies from different image modalities (CT, MRI, etc) with or without fiducials, register them and define a variety of image fusions among them. A brain Atlas and tools for image segmentation are also available. Image reconstructions in axial, coronal and sagital planes can be used along with image reconstruction in planes along and orthogonal to the proposed track to avoid probe intersection with critical structures or vessels. Win-NEUS is a powerful tool for Stereotactic Surgery such as biopsies and treatment of Parkinson disease.

This 510(k) summary for the WIN-NEUS™ Stereotactic Surgery Treatment Planning System states that "All of the items contained in the tables of section 10 have been found to be substantially equivalent" in reference to performance data. However, the provided document DOES NOT contain section 10 or any specific performance acceptance criteria or study details. Therefore, I cannot extract the requested information.

The document only states that the device is substantially equivalent to a predicate device (Leksell SurgiPlan, K033340). Substantial equivalence means that the device is as safe and effective as a legally marketed device. It does not necessarily require the same type of detailed performance criteria and studies as might be seen for novel devices.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about performance studies (sample sizes, ground truth, experts, adjudication, MRMC, standalone performance, training set details) because this information is not present in the provided text.

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