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CadPlan is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices and x-ray energies from 4 to 50 MV, as well as Cobalt-60, and electron energies from 4 to 50 MeV, and to plan brachytherapy treatments.

CadPlan Helios is an inverse planning tool for creating highly conformal plan using intensitymodulated fields. Inverse planning refers to the process of computing the optimum field intensities for the required numbers of beams to achieve the desired dose of distribution with specified complaints. It allows for creation of in-field intensity profiles that produce the desired dose distribution as precisely as possible. Helios computes the in-field intensities on the basis of specified clinical constraints for the desired dose distribution inside target volumes and critical organs. The calculated intensity profiles are then converted to a pattern of dynamic Multi-Leaf Collimator (MLC) motions. The combination of modulated dose delivery and dynamic MLC motion allows dose to be conformed precisely to anatomical structures. Helios implements the inverse planning algorithm and support of dynamic MLC for Intensity Modulated Radiation Therapy.

This document is a 510(k) Premarket Notification for the CadPlan Helios Option 6.0, an inverse planning tool for radiation therapy. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document primarily focuses on describing the device, its intended use, and its substantial equivalence to a predicate device for FDA approval.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text.

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