(87 days)
syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation 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 view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.
The software combines the following digital image processing and visualization tools:
- . Multi-modality viewing and contouring of anatomical, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
- Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume ● rendering technique (VRT)
- . Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
- Automated Contouring on CT images
- . Creation of contours on images supported by the application without prior assignment of a planning CT
- Manual and semi-automatic registration using rigid and deformable registration
- Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points
- . 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 ●
- Creation of simple geometric treatment plans ●
- Generation of a synthetic CT based on multiple pre-define MR acquisitions ●
The subject device with the current software version SOMARIS/8 VB60 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 in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for 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.
For the current software version SOMARIS/8 VB60 the following already cleared features have been modified:
- . Reference Point Management
- Patient Marking ●
- Contouring / Routine Contouring
- Structure Set Management ●
- Synthetic CT
- Basic Feature of syngo,via RT Image Suite
The provided documentation relates to the Siemens syngo.via RT Image Suite, specifically describing its 510(k) premarket notification for a new software version (SOMARIS/8 VB60) that includes an AI-based algorithm for synthetic CT generation.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document describes performance criteria for the AI-based algorithm for generating synthetic CT images from MR images. While not presented in a formal table with specific thresholds, the text outlines the key metrics evaluated and the results.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Geometric Fidelity (Body Outline Deviation) | Average deviations in the body outline were smaller than 1 mm. |
| HU Accuracy (Soft Tissue) | Within 50 HU. |
| HU Accuracy (Bone Tissue) | Within 200 HU. |
| Performance vs. Predicate Device | Equal performance in geometric accuracy and superior performance in HU accuracy. |
The document states that the geometric deviation of `
§ 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.