(84 days)
Helax-VISIR is designed to be a tool for supporting the process of scheduling, preparing, setting up, delivering and recording radiation therapy. It will help administrating patient sessions through the booking functionality and activity reports. It will fetch data from dose planning systems and simulators automatically or by manual input. At each individual treatment Helax-VISIR will present setup data to the operator and also to the linac through a specific interface. Actual setup will be verified. During treatment Helax-VISIR can monitor the progress of both monitor values and optional in vivo dosimetry. All data relevant for the given treatment can be recorded.
Helax-VISIR is intended to be operated by physiciats, physicians and radiographers skilled in radiation therapy and trained in using the system. Thus the functionality of VISIR is to a large extent based on warnings instead of inhibiting actions. Absolute inhibition is used in situations where e.g. inconsistencies could be introduced. The overall philosophy is not to take control but to help the staff detecting unintentional actions.
The intended use is the same as the predicate devices.
Indications For Use: radiation treatment Patients undergoing according to prescribed treatment plan.
The Helax-VISIR system is a modern product for improved treatment management and quality assurance in Radiotherapy. The increasing complexity of treatment techniques and equipment requires a flexible and vendor-independent system for the booking, set-up, verification and documentation of the radiotherapy process.
The provided text is a 510(k) premarket notification summary for the Helax-VISIR system, a Verification and Information System in Radiotherapy. It outlines the device's intended use, technological characteristics, and its substantial equivalence to a predicate device.
However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Instead, the document states:
- "Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device."
- "The Helax-VISIR has the same technological characteristics and is similar in design, function, and application to the predicate device."
- "There are no differences between the technology of the predicate device and the Helax-VISIR and only minor differences in configuration and specifications... These differences do not alter the intended use or affect the safety and effectiveness of the Helax-VISIR system when used as labelled."
This indicates that Helax AB demonstrated substantial equivalence primarily through comparison with the predicate device and general performance testing, rather than an independent clinical study with detailed acceptance criteria and expert evaluation as would be typical for more complex AI-enabled medical devices today.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document focuses on regulatory compliance through substantial equivalence, not on a detailed scientific study with quantifiable acceptance criteria demonstrated through a specific test set.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.