(338 days)
The FOCUS Pilot Contouring Workstation permit contouring of patient tumors and critical structures on images (CT slices) at a workstation remote from the FOCUS Radiation Treatment Planning System. Images are drawn from the FOCUS RTP System, contoured and then returned to the FOCUS RTP System for completion of the treatment planning activity.
The FOCUS Pilot Contouring Workstation ("the CWS") is designed to be used in conjunction with the FOCUS Radiation Treatment Planning System (K915691). The CWS (the "client") relocates the time-consuming task of image contouring from the RTP System (the "server") and permits it to be done remotely on a workstation designed solely for contouring. This frees the RTP System for performance of dose calculation and display, treatment plan comparison, source file maintenance and other tasks associated with radiation treatment planning.
The CWS will accept patient image data (CT slices) from the FOCUS RTP System and stores them on its hard drive prior to recalling them for contouring. The CWS provides the user tools with which to review the images and contour and label tumor volumes and critical structures. Patient demographic data, in addition to that entered at the RTP System, is also able to be entered at this workstation. After this contouring has been performed, the images are stored on the PC hard drive prior to being returned to the RTP system for subsequent use in treatment planning. The Contouring Workstation does no treatment planning, and does not accept plan information for display and/or modification. Screen capture printing is available from the CWS.
The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) summary for the FOCUS Pilot Contouring Workstation, focusing on demonstrating substantial equivalence to predicate devices. It describes the device's function, intended use, and technological characteristics compared to similar systems. It also discusses the safety measures and quality checks in place after the contouring process, but these are not presented as acceptance criteria for the device itself.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth.
§ 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.