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The Varian Eclipse device is used to plan photon and electron radiation therapy treatments employing linear accelerators, and electron energies from 1-50 MeV. Eclipse will plan the 3D in t , as won as Obout ouj and breat to combined modality plans, coplanar and non-coplanar fields, static and ARC fields, beam modifiers, and beam intensity modulators.

Eclipse also includes tools for treatment preparation (diagnostic image and analysis, contouring and segmentation) and plan review.

The Varian Eclipse™ Treatment Planning System has been modified to include a new a new photon dose calculation algorithm, Analytical Anisotropic Algorithm (AAA). The AAA dose calculation model is a 3D convolution/superposition algorithm that models primary photons, photons scattered in the medium, contamination electrons and transport electrons near tissue heterogeneities. The AAA dose calculation model is comprised of two main components, one being the configuration algorithm and the other one the actual dose calculation algorithm.

The provided text is a 510(k) summary for Varian Medical Systems' "Eclipse with AAA" device, along with the FDA's clearance letter. This type of regulatory document primarily focuses on establishing substantial equivalence to a predicate device and outlining the intended use and technological characteristics.

It does not contain the specific information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies.

The 510(k) summary states that the Eclipse with AAA is a modification of an existing device (Varian Eclipse, K030981) and includes a new photon dose calculation algorithm (Analytical Anisotropic Algorithm - AAA). It mentions that "The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. This chart is located in Tab 8 of the submission." However, "Tab 8" is not included in the provided text.

Therefore,Based on the provided text, I cannot answer the questions regarding acceptance criteria, study details, and performance evaluations. The document focuses on regulatory clearance by demonstrating substantial equivalence to a predicate device, rather than detailed performance study results.

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