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CADPLAN is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 50 MV, as well as Cobalt-60, and electron energies from 1 to 50 MeV, and to plan brachytherapy treatments. CADPLAN will plan the 3D radiotherapy treatment approaches to combined modality plans, asymmetric and non-coplanar field, total body irradiation, multileaf collimators, motorized and dynamic wedges, customized blocking, compensating filters, and bolus.

CADPLAN includes export capabilities to verify beam and patient data, dose planning results, and provide on-line information to block-cutting devices.

Varian CADPLAN is a comprehensive 3D RTP system for radiation dose modeling of patients undergoing photon or electron therapy or brachytherapy, based on modern UNIX technology. External beam calculation is fully 3-dimensional supporting coplanar and non-coplanar fields. The beam model takes into account collimator rotation, off-center calculation, and irregular field shape. Different energies and treatment modalities (fixed, isocentric, and arc) can be combined in the same plan; and external beam, intracavitary, and interstitial plans can be combined. Wedges, both static and dynamic, blocks, compensators, and boluses can be used. All images, graphical data, and texts are displayed on one high resolution monitor. Easy to use operation is provided with mouse selectable menus.

The provided text is a 510(k) summary for the Varian CADPLAN Radiation Therapy Treatment Planning (RTP) System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods.

The document is purely a regulatory submission outlining the device's purpose and its equivalence to an existing product for market approval. It is from 1997, and the level of detail regarding performance studies for AI/software-as-a-medical-device (SaMD) was not as extensive as it is today.

Therefore, I cannot provide the requested information based on the given text. The text explicitly states:

• "CADPLAN has no significant differences in design, materials, energy source or other technological characteristics compared Considerations: to the predicate device." This indicates that the approval was based on substantial equivalence, not on extensive performance studies proving specific acceptance criteria.
• The document primarily focuses on intended use and technological considerations in comparison to a predicate device (FOCUS by Computerized Medical Systems, Inc.).

To answer your questions, one would need access to the actual performance studies, which are not included in this 510(k) summary document.

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