(43 days)
The syngo® RT Interface is as an accessory to the linear accelerator system to provide input to the planning for the delivery of x-ray photon and electron radiation for the therapeutic treatment of cancer where indicated.
The syngo® RT Interface supports the oncology workflow as a medical application for viewing, manipulation, contouring, 3D visualization and comparison of medical images from multiple imaging modalities.
This application allows the user to convert, store and export volume of interest (VOI) structures in DICOM® RT format for use in radiation therapy planning.
The syngo® RT Interface offers the segmentation tools, which are currently cleared in the Virtual Simulation [VSIM] module of the syngo® Dosimetrist v2.7 workspace, to be available from the RT Connect workflow on the MM Oncology Reading pane. The syngo® RT Interface software is based on the currently cleared SIEMENS syngo.via software's client /server architecture and is intended to be marketed as a licensable plug-in to the currently cleared syngo.via MM Oncology™ workspace. The basic design, safety features and function of the segmentation tools supported within the syngo® RT Interface remain unchanged from their currently cleared intended use and functions, however, the segmentation tools have been modified to run on the syngo.via architecture.
The syngo® RT Interface supports the RT Connect workflow application within the MM Oncology Reading pane that provides access to patient imaging data. The clinician can view and make clinical assessments of the area of medical interest (findings) using a variety of digital diagnostic radiographic [DDR] and other imaging modality images such as PET, CT, MR, and SPECT that conform to the DICOM standard.
The RT Connect workflow on the MM Oncology workspace supports the segmentation tools for use on a three dimensional view allowing for a virtual setup of the patient's preliminary treatment planning. A variety of segmentation tools are supplied to assist in the delineation of structures for contouring and placement on target organ(s) or findings prior to the data transfer for use by the third party treatment planning systems [TPS].
Additionally, the segmentation tools available through the syngo® RT Interface supports a workflow that enables the user to delineate, edit, or delete contours, and automatically convert them to DICOM RT structures. The DICOM RT Structure objects can be transfer to a currently cleared and commercial DICOM compatible treatment planning system to be used in the development of the treatment plan by the clinician or archived.
The provided text describes the syngo® RT Interface and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.
Specifically, the document states:
- "In summary, SIEMENS is of the opinion that the syngo® RT Interface update does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate devices."
- "The basic design, safety features and function of the segmentation tools supported within the syngo® RT Interface remain unchanged from their currently cleared intended use and functions, however, the segmentation tools have been modified to run on the syngo.via architecture."
These statements indicate that the submission relies on the established performance of the predicate devices and the unchanged fundamental functions of the segmentation tools, rather than new performance studies with specific acceptance criteria for the syngo® RT Interface itself.
Therefore, I cannot extract the requested information (table of acceptance criteria, device performance, sample sizes, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, training set sample size, or ground truth establishment for training) from the provided text because it is not present.
§ 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.