(174 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 VB70 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 VB70 the following already cleared features have been modified:
- Patient Marking
- Contouring
- 4D Features ●
- Basic Features of the subject device ●
The provided text describes the acceptance criteria and a study demonstrating that the lobe-based lung ventilation algorithm within the syngo.via RT Image Suite meets these criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| AI-based Lung Lobe Segmentation | Unchanged geometric overlap with annotated ground truth as measured by DICE compared to the predicate device. | Mean DICE of 0.92 for the lung lobes across the test set (passed acceptance criterion). |
| Lobe-based Lung Ventilation (4D-CT Normal Breathing) | Median ventilation distribution should be well aligned with ground truth obtained from literature. | Median ventilation of about 20% for the five lung lobes, which is well aligned with literature ground truth. |
| Lobe-based Lung Ventilation (Breathhold CT) | Significant Pearson correlation between a proxy for vital capacity calculated by the device and vital capacity measured by PFT (spirometry). | Significant Pearson correlation of R = 0.63 (p |
§ 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.