(63 days)
Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.
Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. Leksell Gamma Plan® is intended to be used for planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy.
The provided text describes the Leksell GammaPlan®, a computer-based dose planning system for Leksell Gamma Knife®, and its 510(k) submission. However, it does not contain information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established for training or test sets.
The document is a 510(k) summary for the device, focusing on its substantial equivalence to predicate devices (Leksell GammaPlan® K090972 and XiO RTP K092132) rather than detailed performance study results. The FDA letter confirms the substantial equivalence determination but does not present a detailed study.
Therefore, I cannot provide the requested information.
§ 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.