(84 days)
KonRad is intended to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). Once the optimization is complete the dose distribution and dose volume histogram curves are displayed for the user to evaluate. After approval the results are exported to the delivery equipment, Linear Accelerator or Record and Verify system, for final verification before treatment delivery.
KonRad as described in this submission is a radiation therapy treatment planning package designed to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). KonRad is a PC based system. KonRad software uses defined anatomical structures for the optimization and treatment planning process. The images or contours are based on tomographic images imported via Dicom and Dicom RT protocols from various sources, e.g. CT. Virtual Simulation software etc. The users treatment machine beam data is utilized for plan calculation. The user defines the desired dose to be delivered to the target and the surrounding structures. Values are entered to weight the optimizations according to the importance of reaching the dose objectives for the target and other structures. After the user starts the optimization, the software calculates the required MLC or partial attenuation block shapes needed to achieve the dose objectives. This is done for each beam simultaneously and the resulting dose distribution and DVH are displayed. Once the optimization is complete, the dose distribution and DVH are displayed for the user to evaluate. If the user is not satisfied with the results of the optimization, the input parameters can be modified and the optimization repeated until the desired results are met. When the user is statisfied, the final treatment plan can be stored and is ready for export. The resulting treatment plan can be exported, to the appropriate delivery equipment. Linear Accelerator or Record and Verify system (R&V) via defined protocols, e.g. Dicom RT. The export of the treatment plan does not activate the delivery equipment, all information must be verified by the user prior to treatment.
The provided information does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics for KonRad. This document is a 510(k) premarket notification for a radiation therapy planning system, KonRad, dated July 1, 2002. It focuses on establishing substantial equivalence to a predicate device (Nucletron PLATO ITP, K992434) rather than presenting a performance study with acceptance criteria.
The information primarily describes the device's intended use and technological considerations, stating it "enhances the functionality of the defined predicate device by providing the ability to finalize the dose calculation." However, it does not include a comparative effectiveness study, standalone performance metrics, or details on how the device's accuracy or efficacy was evaluated against specific criteria.
Therefore, I cannot provide the requested table and study details as the input document does not contain this information. The document focuses on regulatory approval through substantial equivalence, not on detailed performance validation against explicit acceptance criteria.
§ 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.