(201 days)
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
iPlan RT Dose is a software program to generate treatment plans and to simulate the dose delivery for external beam radiotherapy. The system is the evolutionary successor of the predicate device BrainSCAN (K994413). It is specialized for stereotactic procedures for cranial as well as extracranial lesions. It includes functions for all relevant steps from outer contract detection to quality assurance.
iPlan RT Dose incorporates most capabilities of the predicate device BrainSCAN. The device incorporates conformal beams, conformal IMRT beams, both static and dynamic arc treatments. The system calculates dose using a convolution algorithm similar to the predicate device BrainSCAN. The documentation & export allows producing printouts of all parameters and results for the creation of DICOM RT (RT Plan and RT Image) files.
This document is a 510(k) summary for the iPlan RT Dose system, a radiation treatment planning system. It establishes substantial equivalence to a predicate device (BrainSCAN, K994413). It does not contain information regarding acceptance criteria, device performance metrics, or details of specific studies conducted to establish performance characteristics in the way you've outlined.
The document states: "iPlan RT Dose has been verified and validated according to BrainLAB's procedures for product design and development. The validation proves the safety and effectiveness of the system." However, it does not provide the specifics of these verification and validation studies, including acceptance criteria or performance results.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The other requested information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is also not present in this 510(k) summary.
In summary, the provided text does not contain the information needed to fill out your request.
§ 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.