(49 days)
syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).
It provides tools to efficiently view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create and modify simple treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.
The software combines following digital image processing and visualization tools:
· Multi-modality viewing and contouring of anatomical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI. Linac Cone Beam CT (CBCT) images and dose distributions
· Multiplanar reconstruction (MPR) think minimum intensity projection (MIP), volume rendering technique (VRT)
- · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
- · Creation of contours on any type of images without prior assignment of a planning CT
· Manual and semi-automatic registration using rigid and deformable registration
· Supports the user in comparing, and adapting contours based on datasets acquired with different imaging modalities and at different time points
· Supports the user in comparing images and contours of different patients
- · Supports multi-modality image fusion
- · Visualization and contouring of moving tumors and organs
- · Management of points of interest including but not limited to the isocenter
- · Management of simple treatment plans
- · Generation of a synthetic CT based on multiple pre-define MR acquisitions
syngo.via RT Image Suite is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy. The subject device syngo.via RT Image Suite with software version SOMARIS/8 VB30 is a further extension of the previously cleared primary predicate device syngo.via RT Image Suite with software version SOMARIS/8 VB20 and supports the following modifications:
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- Modified Indications for Use Statement
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- Support of software version SOMARIS/8 VB30 which supports the following functionality:
- a. Support of Beam Placement
- Support of Synthetic CT b.
- Support of modified contouring tools c.
- i. Routine Contouring
- ii. Advanced Contouring
- iii. Rapid Results Technology
- d. Support of modified structure management
syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for easy manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation.
The provided text is a 510(k) summary for the syngo.via RT Image Suite, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed clinical performance metrics and acceptance criteria for a new device.
Therefore, the document does not contain the specific information requested in the prompt regarding acceptance criteria, a standalone study, sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC study results, or detailed ground truth establishment for a clinical performance evaluation of the device as if it were a new AI/CADx system.
The document details non-clinical testing and verification/validation activities to ensure the software functions as intended and meets safety and performance standards. It also mentions "supportive articles" for specific device functionality, including the "Synthetic CT feature," which "demonstrates the classification of tissues for brain acquisitions method used for the synthetic CT feature included in this submission." However, these are not presented as a standalone clinical study with the requested metrics.
Thus, I cannot populate the table or answer the specific questions directly from the provided text as it does not contain that 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.