(97 days)
It is intended for localization of patient position in the conduct of radiation therapy with a linear accelcrator and registration of patient position between the planning and conduct of treatment. Patient Tracking System is an optical system for tracking patient position to linear accelerators used for before and during facilomeraly. It is an accessory of 3 dimensional radiotherapy.
DynaTrac System Cod. 50-1A is a state-of-the-art optical tracking system that tracks patient position before and during a radiotherapy treatment session. It can track the patient in real time allowing the treatment system to respond to uncxpected movements. It shortens the time required to prepare a patient for a treatment session because of the speed with which spatial registration with a treatment plan can be confirmed.
The provided text is a 510(k) summary for the DynaTrac System, an optical patient tracking system for radiation therapy. It establishes substantial equivalence to a predicate device (ExacTrac) but does not contain any information about specific acceptance criteria, study designs, or performance metrics from a validation study.
Therefore, I cannot provide the requested information in a table or as descriptive text regarding the acceptance criteria and a study proving the device meets them. The document focuses on regulatory approval based on demonstrating substantial equivalence, not on presenting performance data from a specific study.
The document only states: "DynaTrac has the same intended use and Davoluntial Dquiraliso to ExacTrac. There are no technical differences that raise issues of safety and effectiveness." This implies that the device is considered equivalent based on its design and intended use being similar to a legally marketed device, not through a new performance study detailed in this submission.
§ 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.