(48 days)
syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality 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) thin/thick, 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, contouring, 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 ●
The subject device with the current software version SOMARIS/8 VB40 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. 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.
Here's a breakdown of the acceptance criteria and study details for the syngo.via RT Image Suite, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Predicate vs. Subject) | Reported Device Performance (Subject Device) |
|---|---|---|
| Detection Rate (OARs) | Improved over predicate device | 100% for Brain, Liver, Kidney Left, Kidney Right |
| Mean Average Symmetric | Improved over predicate device | Ranged from 0.64 mm to 3.04 mm |
| Surface Distance (ASSD) | (Specifically 0.64 mm for Femur Head Right, 3.04 mm for Heart) | |
| Mean DICE Coefficient | Improved over predicate device | Ranged from 0.85 to 0.97 |
| (Specifically 0.85 for Prostate and Rectum, 0.97 for Heart) |
Note: The document states the subject device "improved for all evaluated OAR" for both ASSD and DICE coefficient compared to the predicate device, but does not provide the specific predicate device values for direct comparison in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 32 datasets
- Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated in the provided text.
- Qualifications of Experts: The ground truth was "manually annotated." While this implies expert review, the specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. The document mentions "manually annotated ground truth," but does not specify if multiple annotators were used and how discrepancies were resolved (e.g., 2+1, 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The study described is a comparison of the subject device (algorithm) performance against manually annotated ground truth, and an improvement over a predicate device's algorithm. It does not assess human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Yes. The clinical testing summary describes the performance of the algorithm itself, specifically focusing on "detection rate" and "segmentation quality" based on metrics like ASSD and DICE coefficient. It compares the subject device's algorithm (SOMARIS/8 VB40) to the predicate device's algorithm (SOMARIS/8 VB30).
7. Type of Ground Truth Used
- Type of Ground Truth: Expert consensus (specifically, "manually annotated ground truth").
8. Sample Size for the Training Set
- Training Set Sample Size: Not explicitly stated. The document mentions a "new deep learning-based approach that uses an adversarial network" and that its "segmentation algorithm were validated separately using a testing set of 32 datasets," but does not provide details on the training set size.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not explicitly stated. While the test set ground truth was "manually annotated," the method for establishing the training set ground truth, especially for a deep learning model, is not described in this summary.
§ 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.