(77 days)
The Extracranial Radiotherapy System is intended for stereotaxic patient positioning and localization during imaging and treatment of extracranial targets.
The Extracranial Radiotherapy System is a device consisting of a carbon fiber table, a patient support cushion and lateral support panels, stereotaxic plates and related fasteners and assembly tools. During treatment the patient lies supine on the fitted cushion. Four stereotaxic plates surround the patient during CT imaging, with one plate between the support cushion and the table, two placed laterally and one above the patient. Target positioners on the support assembly are used to align the table with the linear accelerator coordinate axes and to verify the target point for treatment.
The provided text is a 510(k) summary for the Extracranial Radiotherapy System. While it describes the device, its intended use, and substantial equivalence to predicate devices, it does not contain information about specific acceptance criteria, a detailed study proving performance, sample sizes for test/training sets, expert qualifications, or adjudication methods.
The document states that the "Extracranial Radiosurgery System, the STP Complete Module/ZD Stereotaxic Frame and the Marker System for Stereotaxic Navigation demonstrate similar treatment accuracy during testing with CT images." However, it does not elaborate on the specific acceptance criteria for "similar treatment accuracy" or the details of that testing.
Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, or information about ground truth establishment based on the provided text.
§ 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.