(104 days)
syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.
syngo.via MI workflows support the interpretation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology envirents.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.
The syngo.via MI Workflows are software only medical devices which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.
syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. synqo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.
The provided text primarily focuses on the submission of a 510(k) premarket notification for syngo.via MI Workflows VB30A and its substantial equivalence to a predicate device (syngo.via MI Workflows VB20). It outlines the device's intended use, technological characteristics, and compliance with various regulatory standards.
However, the document does not contain the detailed information necessary to fully answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria. The text mentions that "Verification and Validation activities have been successfully performed on the software package," and "All testing has met the predetermined acceptance values," but it does not provide specific numerical acceptance criteria, reported performance values, sample sizes, ground truth establishment, or details of any comparative effectiveness studies.
Therefore, I cannot populate all sections of the table or provide detailed answers to items 2-9.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Design | Functions work as designed | Successfully performed |
| Performance Requirements | Performance requirements met | Successfully performed |
| Specifications Met | Specifications met | Successfully performed |
| Hazard Mitigation | All hazard mitigations fully implemented | Successfully performed |
| Predetermined Values | Predetermined acceptance values met | All testing met |
Missing Information: Specific numerical or qualitative acceptance criteria for particular features (e.g., accuracy of 3D visualization, quantification precision, speed of processing) and the actual reported performance values are not detailed in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing Information: The document states "Verification and Validation activities have been successfully performed," but does not provide any specifics about the sample size of the test set, the provenance of the data used for testing, or whether it was retrospective or prospective.
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)
- Missing Information: This information is not present in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing Information: This information is not present in the provided text.
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
- Missing Information: The document outlines the device as a "medical diagnostic application for viewing, manipulation, 3D-visualization and comparison of medical images" and explicitly states it is a "complement to these standard procedures." It does not describe any MRMC comparative effectiveness study, nor does it provide any effect size for human reader improvement with or without AI assistance. The device is software for image manipulation and viewing, not an AI for interpretation in the sense of directly assisting reader decisions, but rather providing tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing Information: This document does not detail any standalone performance studies. The device is described as an application for viewing and manipulation, implying human interaction.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Missing Information: This information is not present in the provided text.
8. The sample size for the training set
- Missing Information: The document describes the device as a software platform with new features added to a predicate device. It does not mention any "training set" in the context of machine learning, suggesting this is not a machine learning device that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Missing Information: As no training set is mentioned in the context of machine learning, there is no information on how its ground truth would be established.
Summary of what the document does convey:
- The device (syngo.via MI Workflows VB30A) is a software-only medical device for medical image viewing, manipulation, 3D-visualization, and comparison from multiple modalities and time-points.
- It is an updated version of a predicate device (syngo.via MI Workflows VB20) with new features in specific workflows (MM Oncology, MI Neurology, MI Cardiology, MI Reading / SPECT Processing).
- It is intended to run on the Siemens syngo.via software platform.
- Siemens claims substantial equivalence to the predicate device and states that "no changes that raise any new issues of safety and effectiveness."
- Verification and validation activities were successfully performed, and all testing met predetermined acceptance values.
- The device complies with various recognized industry standards (ISO 14971, IEC 62304, NEMA PS 3.1 - 3.20, IEC 62366, ISO 15223-1).
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).