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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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