(62 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 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, 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) 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, 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
syngo.via RT Image Suite 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 combine 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.
syngo.via RT Image Suite provides dedicated tools, which help the medical professional in contouring and evaluating volumes of interest, for example gross target volumes, or organs-at-risk.
The software application works in a similar fashion on any officially supported imaging modality, for example, native contouring is supported on CT but also on MR or PET images.
The following features have been modified:
- Routine Annotation Functionality (modified) ●
- Contouring Tools (modified)
- Patient Marking (modified)
- . Structure Set Management (modified)
- Alignment Tools (modified)
- Dose Evaluation (new)
The provided text describes the "syngo.via RT Image Suite" and its 510(k) submission, comparing it to predicate devices. However, the document primarily focuses on demonstrating substantial equivalence through non-clinical testing (integration and functional tests, software verification and validation, risk analysis) and adherence to recognized standards. It does not present a detailed study with specific acceptance criteria and reported device performance metrics in the format requested, especially regarding clinical metrics, sample sizes for test sets, ground truth establishment, or comparative effectiveness studies with human readers.
The document states that "The testing results support that all the software specifications have met the acceptance criteria," but it does not specify what those acceptance criteria were or present the reported device performance against those criteria in a quantitative manner.
Therefore, much of the requested information cannot be extracted directly from this document.
Here's an attempt to answer based on the available information, with clear indications where information is missing:
1. A table of acceptance criteria and the reported device performance
The document states, "The testing results support that all the software specifications have met the acceptance criteria." However, it does not explicitly list the specific acceptance criteria or the quantitative reported device performance for the syngo.via RT Image Suite. The "Performance Data" section primarily describes the types of tests conducted (non-clinical integration and functional tests, software verification/validation, risk analysis) and a general conclusion that the device performs as intended and meets acceptance criteria.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "non clinical tests (integration and functional)" and "verification/validation testing" but does not specify the sample size of cases, images, or data used for these tests, nor the provenance of any data (e.g., country of origin, retrospective/prospective). Given the non-clinical nature of the described tests, clinical "test sets" in the sense of patient data with ground truth might not have been the primary focus of the performance data presented here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. As the described performance data is related to non-clinical software testing, there is no mention of experts establishing ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is mentioned, likely because the performance data section focuses on software verification and validation rather than a clinical study requiring adjudicated ground truth.
5. 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
The document does not indicate that an MRMC comparative effectiveness study was performed or that human readers' performance with/without AI assistance was evaluated. The device is described as an "image visualization, multimodality manipulation and contouring tool" that helps preparation and response assessment, implying it supports human users, but no study on human performance improvement is detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not explicitly present data from a "standalone" algorithm performance study in a clinical context. The performance data focuses on "non clinical tests (integration and functional)" along with "software verification and validation," which are evaluations of the software's functionality and adherence to specifications, not necessarily its autonomous clinical performance as an "algorithm only" device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth used for any particular test set. Given the described non-clinical nature of the tests, ground truth likely refers to expected software behavior or outputs according to specifications rather than clinical benchmarks like pathology or expert consensus on medical images.
8. The sample size for the training set
This information is not provided in the document. The text does not refer to a "training set," which would typically be relevant for machine learning or AI-based devices. While the device has "semi-automatic contouring" and "manual and semi-automatic registration," the document describes these as features without detailing any machine learning training processes or associated datasets.
9. How the ground truth for the training set was established
This information is not provided in the document, as no training set is mentioned in the context of performance data.
Summary of what can be inferred or is explicitly stated regarding the "study":
- Type of Study: Non-clinical (integration and functional tests, software verification and validation).
- Purpose: To demonstrate conformance with special controls for medical devices containing software, mitigate identified hazards (risk analysis), and support the claim of substantial equivalence to predicate devices.
- Acceptance Criteria (General): "all the software specifications have met the acceptance criteria." (Specific criteria not detailed).
- Reported Device Performance (General): The device "performs as intended" and "performance is comparable to the predicate devices." (Specific quantitative performance metrics not detailed).
- Standards Conformed To: DICOM Set (PS 3.1 - 3.20), IEC 62304 (Medical device software - Software life cycle processes), ISO 14971 (Application of risk management to medical devices), IEC 60601-1-6 (Usability), IEC 60601-1-4 (Programmable electrical medical systems).
- Support for Claims: Six scientific articles are mentioned as used to support marketing claims in the product brochure, but these are not described as part of the core performance data reported for this 510(k) submission.
In conclusion, the document focuses on regulatory compliance through non-clinical software testing and comparison to predicates, rather than providing a detailed clinical study with the specific criteria and performance metrics requested.
§ 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.