(45 days)
The RPM Respiratory Gating System is used to obtain tracking of the subject respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. It can be also used to monitor the patient position during the image acquisition, simulation and treatment.
The Varian RPM Respiratory Gating Device is an attachment to the Varian Clinac radiation therapy treatment systems, radiation therapy simulators, and image acquisition devices used for diagnostics and radiation therapy. The RPM system senses and records the respiratory motion and respiratory state of a patient using video tracking of an optical marker placed on the patient to a location indicated by the physician. Video camera is connected to a PC workstation is used for video tracking of markers.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for the RPM Respiratory Gating System.
It describes the device, its intended use, and states that it is substantially equivalent to a predicate device based on a comparison of technological characteristics. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes, data provenance, or ground truth establishment for any test sets.
- Details on expert involvement, adjudication methods, or MRMC studies.
- Results of a standalone algorithm performance study.
The document primarily focuses on establishing substantial equivalence to a predicate device, which is the basis for 510(k) clearance, rather than presenting detailed performance study results against specific 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.