(19 days)
syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options. syngo via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
syngo.via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. syngo via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo. Via integrates Radiology Information Systems (RIS) to enable customer specific workflows. syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x (K0925519, cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo. via medical device. syngo. via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages.
The provided 510(k) summary for K123375, Siemens syngo.via, primarily describes a Picture Archiving and Communications System (PACS) software solution. It does not contain the specific details about acceptance criteria, device performance, or a standalone study that would be necessary to fully answer your request.
The document focuses on the general capabilities of syngo.via related to viewing, manipulation, communication, and storage of medical images, and its substantial equivalence to a predicate device (syngo.x). It explicitly states that advanced applications (clinical applications) designed for syngo.via are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device.
This means that the information you are looking for regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth would be found in the 510(k) submissions for those specific advanced clinical applications, not in this general PACS software submission.
Therefore, I cannot populate the requested tables and information based on the provided text.
Here's what I can extract and what is missing based on your template:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document for syngo.via itself. This 510(k) is for the core PACS functionality, not specific diagnostic algorithms. | Not specified. The document focuses on functional equivalence to a predicate device (syngo.x) for general PACS operations (viewing, manipulation, communication, storage). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study Done? No. This 510(k) is for a PACS system, not an AI-powered diagnostic application that would typically use an MRMC study for comparative effectiveness with or without AI assistance. The document explicitly states that "advanced applications (clinical applications) designed for syngo.via... are not part of this 510(k) submission and not part of the syngo.via medical device".
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study Done? No. The syngo.via described here is a foundational PACS system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable, as detailed performance studies for specific diagnostic tasks are not part of this 510(k) for the syngo.via PACS system.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/Not specified. This document does not describe the development or training of a specific diagnostic algorithm.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable/Not specified.
Conclusion:
The provided 510(k) is for the syngo.via PACS system itself, which provides viewing, manipulation, communication, and storage functionalities for medical images. It explicitly states that specific "advanced applications (clinical applications)" which would contain diagnostic algorithms with measurable performance metrics, acceptance criteria, and associated studies, are not part of this submission and are filed separately. Therefore, the detailed information requested in your template is not present within this particular 510(k) summary.
§ 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).