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Helax-TMS is a 3D radiotherapy treatment planning system for radiation dose planning, but not treatment, of patients undergoing external beam or brachytherapy treatment in the oncology clinic. The system is designed to lead the user through a logical flow planning process.

Based on quality assured radiation therapy input data Helax-TMS is used to plan radiation treatments with:

• Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 4 to 50 MeV, proton energies from 1 to 275 MeV as well as cobalt-60 units. Helax-TMS will plan 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorised and dynamic wedges; customised blocking; compensating filters; and bolus.
• Brachytherapy units for patients undergoing interstitial or intracavitary treatment in the oncology clinic.

Export capabilities exists as part of Helax-TMS to verify beam and patient data, dose planning results, and provide on-line information to block-cutting devices and milling machines, multi-leaf collimator control units, as well as record and verify systems.

Helax TMS is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing external beam and brachytherapy treatment in the Oncology clinic. Helax-TMS is a 3-D system, using modern algorithms for dose calculations. The user has the option of selecting either a convolution/superposition pencil beam or a Collapsed Cone algorithm for photons, a Gaussian pencil beam model for electrons, and a proton dose calculation. A brachytherapy module is integrated into Helax-TMS for treatment modeling of interstitial and intracavity brachytherapy techniques. The system software is designed to lead the user through a logical flow planning process.

This document does not contain the information required to populate the table and fully answer the questions. The provided text is a 510(k) summary for a medical device (Helax-TMS Proton Functionality), which focuses on the device's description, intended use, and substantial equivalence to predicate devices, rather than detailed performance studies and acceptance criteria.

Specifically, the document lacks details on:
* Specific acceptance criteria for device performance (e.g., accuracy thresholds for dose calculations).
* Any quantitative performance results from a study.
* Sample sizes for test or training sets.
* Data provenance, expert qualifications, or adjudication methods for ground truth establishment.
* Comparisons with human readers or standalone performance studies.
* The type of ground truth used.

Therefore, I cannot complete the table or answer most of the questions based on the provided text.

Below is a table showing the information that is not available in the provided text.

Acceptance Criteria and Study Details (Information Not Available in Document)

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