(323 days)
The intended use of the device is to identify the patient specific accessories and to aid in the positioning of a patient during radiation therapy.
The intended use of the device is to identify the patient specific accessories and to guide the positioning of patients and accessories for radiotherapy procedures. The system uses optical tracking of optical markers and RFID tracking of RFID tags as the method of identifying the patient and the accessories. The system consists of an optical tracking system with optical markers and RFID tracking system including RFID tags, a RFID identification system, a computer workstation, an interlock unit, a handheld controller, Wireless LAN access points, a video camera and calibration tools.
ldentify displays position and identification information during radio therapy treatment to the user.
The system uses optical tracking of retro reflective disk markers to find the position of the patient and radiotherapy equipment and radio frequency identification (RFID) to obtain identification information from the patient and radiotherapy equipment.
The system consists of a PC, a graphical user interface, a NDI Polaris 3D tracking system, a video camera and a RFID reader.
The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria. The document is a 510(k) summary for the "Identify" system, primarily focusing on its substantial equivalence to a predicate device.
Instead, the document describes the device, its intended use, and argues for its safety and effectiveness based on similarity to an existing device and compliance with general safety standards. There is no mention of a particular study with a defined test set, ground truth, expert involvement, or statistical analysis to demonstrate performance against specific quantitative acceptance criteria.
Therefore, I cannot provide the requested table or details about a study for this device based on the given 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.