(83 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 regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. Contours and images 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 multiparametric images such as but not limited to CT, PET, PET/CT, MRI, and Linac Cone Beam CT (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
- · 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
syngo.via RT Image Suite is an image analysis software used for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-atrisk, 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, 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 synqo.via RT Image Suite post-processing software application is embedded in the Siemens syngo.via framework (operating platform most recently cleared as VB10 K150843) of a multi-user HW/SW architecture with Client-Server support.
Here's a summary of the acceptance criteria and study information for the syngo.via RT Image Suite, based on the provided document.
Important Note: The provided FDA 510(k) summary is a high-level overview. It describes the general V&V processes and states that acceptance criteria were met, but it does not provide specific acceptance criteria values or detailed performance metrics reported for the device. It primarily focuses on demonstrating substantial equivalence to predicate devices and meeting software safety standards.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Specifications | All software specifications have met the acceptance criteria. |
| Risk Analysis | Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all software specifications have met the acceptance criteria. |
| Verification & Validation | Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. |
| Functionality | Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence. syngo.via RT Image Suite performs as intended. |
| Safety | syngo.via RT Image Suite does not introduce any new potential safety risk. |
| Comparability | Device performance is comparable to the predicate devices that are currently marketed for the same intended use. |
| Cybersecurity | Siemens conforms to Cybersecurity requirements by implementing a process to prevent unauthorized access, modifications, misuse, or denial of use. (Note: Hospital's responsibility to comply with IEC 8001-1-2010 mentioned). |
| Standards Compliance | Designed to fulfill requirements of: |
- Digital Imaging and Communications in Medicine (DICOM) Set (PS 3.1 - 3.18)
- Medical device software - Software life cycle processes (IEC 62304 First edition 2006-05)
- Medical devices - Application of risk management to medical devices (ISO 14971 Second Edition 2007-03-01)
- Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance -- Collateral Standard: Usability (IEC 60601-1-6 Edition 3.0 2010-01)
- Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:2000, Consol. Ed. 1.1) |
Study Details
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Sample size used for the test set and the data provenance:
The document states that "Integration and functional tests were conducted for syngo.via RT Image Suite during product development," and "Performance tests were conducted to test the functionality of the subject device." However, no specific sample sizes (e.g., number of cases, images) for the test set are provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified in the provided document. The document describes the device as a "contouring tool" and mentions "software assisted contouring," implying human input. However, it does not detail how specific ground truth for quantitative evaluation would have been established or by whom. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not specified. The document focuses on verification and validation against software specifications and industry standards rather than a formal human-in-the-loop clinical adjudication study. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study is mentioned. The device is described as a "visualization, manipulation and contouring tool" that "helps the preparation and response assessment," and "supports the medical professional with tools." This indicates it's an assistive technology, but a formal study measuring the improvement of human readers with vs. without AI assistance is not detailed. The primary goal of this 510(k) submission is substantial equivalence to predicate devices. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document focuses on the software as a device, and its functions are described as assisting the human professional. While the software has semi-automatic features (e.g., semi-automatic contouring, deformable registration), the submission does not present "standalone" performance metrics (e.g., sensitivity/specificity for a diagnostic task purely performed by the algorithm). Its role is described as a tool for "viewing, manipulation, ... and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning," suggesting it's designed to be used with human oversight and interaction. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As details about specific performance evaluation studies are absent, the type of ground truth used is not explicitly stated. Given the device's function (contouring, image manipulation), it's highly probable that ground truth would involve expert-derived manual contours or measurements against which the software's outputs (e.g., semi-automatic contours, registration accuracy) would be compared. However, this is inferential. -
The sample size for the training set:
Not specified. The document mentions software modifications like "Advanced Contouring" (freehand editing, 3D Nudge tools) and "Deformable Alignment" which might involve machine learning components requiring training data. However, details about training sets (size, composition, ground truth generation) are not included in this 510(k) summary. -
How the ground truth for the training set was established:
Not specified. As the existence and details of a training set are not mentioned, the method for establishing its ground truth is also not provided.
§ 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.