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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 50MeV 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. 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, and a Gaussian pencil beam model for electrons. A Brachytherapy module is integrated into 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.

The provided text describes a 510(k) summary for the Helax-TMS v5.0, a 3D Radiotherapy Treatment Planning (RTP) system. However, it does not contain any information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets said criteria.

The document primarily focuses on:

• Submitter and Contact Information: Basic administrative details.
• Device Name and Classification: Identifies Helax-TMS as a Medical Charged-Particle Radiation Therapy System.
• Legally Marketed Predicate Devices: Lists similar devices already on the market.
• Description of Helax-TMS v5.0: Explains its functionality as a 3D RTP system for both external beam and Brachytherapy, highlighting its algorithms and treatment planning capabilities.
• Intended Use: Specifies the scenarios in which Helax-TMS is used, including various X-ray and electron energies, treatment approaches, and integration with other medical devices.
• Technological Characteristics: States that v5.0 is a modification of previous versions and that these modifications do not adversely affect safety or effectiveness.
• FDA Clearance Letter: A letter from the FDA indicating that the device has been reviewed and found substantially equivalent to legally marketed predicate devices.
• Indications for Use Statement: Reiterates the intended use and capabilities of the device, similar to the description.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory submission for a device, confirming its substantial equivalence, but it does not detail the technical performance evaluation studies or specific acceptance criteria.

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