(58 days)
The 4DITC function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
The 4D Integrated Console provides the user with:
- A treatment verification function to assist the operator of a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set-up parameters
- Treatment safety by preventing the radiation therapy device from commencing irradiation when a linear accelerator. MLC, or MV imager parameter is out of conformance with the treatment plan
- The ability to select patients from a queue provided by the schedule
- The ability to retrieve plans from an information system for the selected patient
- The ability to evaluate a selected treatment plan to determine whether redefined dose limits will be exceeded
- The ability to acquire and edit positional data from radiation therapy devices
- The ability to override specific treatment parameters based on individual user rights
- The ability to send treatment records to an information system
- The ability to interact with the user controls of the PortalVision, the multi-leaf collimator system, the Patient Accessory Verification System, and the treatment verification function at a single workstation
- Provides access to the following:
- Linear Accelerator
- On-Board Imager
- Trilogy RapidArc
The 4D Integrated Treatment Console has been modified to include additional accessory support, treatment tasks and import/export interfaces.
The provided text is a 510(k) summary for the "4D Integrated Treatment Console." This document describes a medical device, its intended use, and its substantial equivalence to previously cleared devices. It is a regulatory submission, not a study report.
Therefore, the input does not contain information about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- How ground truth for the training set was established.
This 510(k) submission focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and intended use, rather than presenting a performance study with acceptance criteria in the manner typically seen for diagnostic AI/ML device clearances.
Conclusion:
Based on the provided document, it is not possible to complete the requested table and answer the questions regarding acceptance criteria and a study proving device performance. The information provided is a regulatory filing for a medical device that assists in radiation therapy treatment setup, not a clinical performance study.
§ 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.