(44 days)
The Positioner system is intended for use in radiation therapy clinics to accurately position patients for radiation therapy in a teproducible way. The system provides information about a patient's position and the adjustments required in order to position the patient as a close as possible to a reference setup. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.
The system consists of a laser-camera unit (LS-100) mounted in the ceiling, and a Windows based application (cPosition) running on a standard PC. The system is non-invasive and uses visible laser light (635nm) to project lines on the patient. The laser-camera scans a 3D surface by projecting a series of laser lines which are recorded by the camera. From each camera recording a 3D contour of the measured object is calculated using triangulation technique and by adding the contours a full 3D surface image is achieved. The PC software compares the scanned image with a reference image and calculates the adjustments required in order to match the two images.
I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets the acceptance criteria. The document is a 510(k) summary for a medical device called "Positioner", which describes its intended use, technological comparison to predicate devices, and the FDA's substantial equivalence determination.
The document states: "However, performance data has been submitted to show that Positioner achieves its intended use and that these technological differences raise no new efficacy or safety concerns." This indicates that a performance study was conducted and submitted to the FDA, but the details of the acceptance criteria and the study results are not present in this summary.
Therefore, I cannot extract the information required in your request, such as a table of acceptance criteria, sample sizes, expert qualifications, or details about standalone or MRMC studies.
§ 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.