(59 days)
TrueBeam is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
The TrueBeam™ Radiotherapy Delivery System is a medical linear accelerator that integrates the previously cleared Trilogy Radiotherapy system and associated accessories into a single device. The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
The provided text K123291 - Premarket Notification [510(k)] Summary TrueBeam Radiotherapy Treatment System is a 510(k) premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed studies with acceptance criteria and performance metrics for novel functionalities.
Therefore, the requested information regarding acceptance criteria and a study proving device performance (including sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not available in the provided text.
The document states:
- "Summary of performance testing: Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly."
This is a general statement indicating that testing was performed, but it does not provide the specific acceptance criteria, method of testing, or detailed performance results that would allow for the completion of the requested table and study breakdown. The focus of this 510(k) is on the "Technological Characteristics" compared to a predicate device, highlighting changes like the addition of a 6 rotational Couch, 2D/3D Matching, 4D CBCT, Multi-scan CBCT Acquisition, and Motion Management Interface (MMI), rather than presenting a performance study for these new features against specific clinical endpoints.
§ 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.