(227 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).
lt provides tools to 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 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, functional, 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 VB80 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. The current software version SOMARIS/8 VB80 are as follows:
- Modifications in Advanced Contouring: Data for training and validation of Advanced Contouring was obtained through clinical collaborations from Asia, Australia, Europe, and America to provide variability in age, gender, geographic origin, etc. Both native and contrasted CT images are included.
- Revised User Interface
The provided text describes the regulatory clearance of "syngo.via RT Image Suite" and includes information about its performance evaluation. The focus of the performance data section is on the AI-based autocontouring feature.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the AI-based autocontouring feature were defined based on the Dice coefficient, a commonly used overlap metric. The text states:
"All tests passed the defined acceptance criteria on the geometric overlap with the ground truth. The evaluation results confirm the clinical safety and performance of the autocontouring feature."
While the specific numerical threshold for the Dice coefficient acceptance criterion is not explicitly stated in the provided document, the statement confirms that the results met the pre-defined criteria.
Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria (Explicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Autocontouring | Passed defined acceptance criteria on geometric overlap with ground truth (based on Dice coefficient) | "All tests passed the defined acceptance criteria on the geometric overlap with the ground truth. The evaluation results confirm the clinical safety and performance of the autocontouring feature." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: 413 subjects
- Data Provenance: The test data was generated from an independent set not seen during training. It covers a wide range of CT scanners and acquisition parameters.
- Geographic Origin: Europe (IT, PT, CH, UK, NL, DE), North America (US, CA), South America (BR), Australia, Asia (JP, IN).
- Retrospective/Prospective: Not explicitly stated, but "obtained through clinical collaborations" suggests retrospective collection of existing clinical data.
Breakdown of Test Set Distribution (from Table 1):
- Data Source: Europe: 58, US: 165, Canada: 39, South America: 78, Australia: 28, Asia: 33, unknown: 12
- Body Region: Head&Neck: 113, Thorax&Abdomen: 216, Pelvis: 84
- Gender: Male: 188, female: 174, Unknown: 51
- Age: 70: 20, unknown: 340
- Slice thickness (in mm): 3: 19
- Manufacturer (Scanner): Siemens: 126, GE: 77, Philips: 140, unknown/others: 70
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: An "expert team" was used, but the specific number is not provided.
- Qualifications: "based on well accepted international contouring guidelines". The specific qualifications of the experts (e.g., radiologist with X years of experience) are not detailed.
4. Adjudication Method for the Test Set:
- The ground truth was established by an "expert team" and then followed by a "rigorous independent quality assessment." This suggests a form of review or adjudication, but the exact method (e.g., 2+1, 3+1) is not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. The provided text describes a standalone performance evaluation of the AI algorithm (autocontouring feature) against a manually annotated ground truth. It does not mention a comparative study involving human readers with and without AI assistance to measure improvement in human performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The performance evaluation described is purely a standalone assessment of the AI-based autocontouring feature. It compares the algorithm's output directly to the "manually annotated ground truth" using the Dice coefficient.
7. The Type of Ground Truth Used:
- Expert Consensus/Manual Annotation: "Manual ground-truth segmentations were annotated by an expert team based on well accepted international contouring guidelines, followed by a rigorous independent quality assessment."
8. The Sample Size for the Training Set:
- The document states that the validation data (test set) was "20% of the available data." This implies the training set was the remaining 80% of the total available data. However, the total available data size for both training and validation is not explicitly stated. Thus, the specific numerical sample size for the training set cannot be determined from this text.
9. How the Ground Truth for the Training Set was Established:
- While not explicitly detailed for the training set, the text mentions that "Data for training and validation of Advanced Contouring was obtained through clinical collaborations from Asia, Australia, Europe, and America to provide variability in age, gender, geographic origin, etc."
- Given the method for the test set ("Manual ground-truth segmentations were annotated by an expert team"), it is highly probable that the ground truth for the training set was established through a similar process of expert manual annotation, though this is not explicitly confirmed for the training data in this section.
§ 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.