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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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The TMS Brachytherapy Module, Version 3.0, is a 3D Radiotherapy Treatment Planning (RTP) system for radiation dose planning of patients undergoing interstitial or intracavitary treatment in the Oncology clinic. The system software is designed to function as an integrated part of the TMS (Treatment Management System) radiotherapy treatment planning system (K953391). The TMS Brachytherapy Module is used for planning the treatment only, not for performing the treatment.

TMS Brachytherapy is an integrated work module for treatment modelling of interstitial and intracavity Brachytherapy treatment techniques. The work module is designed to assist in treatment planning in accordance with the broad range of clinical routines and therapy techniques. The TMS Brachytherapy work module provides support in treatment design by supplying tools for source channel definition, source positioning, manual optimisation of source weights, presentation of dose distributions, and point dose values in arbitrary sections and evaluation of treatment tactics. The structure of the work module parallels that of the external beam module in the design of the user interface.

This document does not contain the information required to populate the requested table and study details. This document is a 510(k) summary for a brachytherapy treatment planning system. It describes the device, its intended use, and states that its technological characteristics and performance are equivalent to a predicate device.

Specifically, the document lacks:

• A defined set of acceptance criteria (e.g., specific accuracy metrics, thresholds).
• Any reported device performance values against such criteria.
• Details about a specific study involving a test set, including sample size, data provenance, number/qualifications of experts, or adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
• Details about the type of ground truth used or how it was established for either testing or training.
• Information regarding a training set's sample size or ground truth establishment.

The "Performance Evaluation" section merely states that "the TMS Brachytherapy system consistently performed within its system requirements specifications and equivalently to the predicate device," without providing specific data or a study design to support this claim in the context of the requested details.

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