(15 days)
The syngo MultiModality Workplace is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media.
The syngo MultiModality Workplace can be configured as a stand-alone diagnostic review and post-processing workplace with a variety of syngo- or Windows XP-based software options, that are intended to assist the physician in diagnosis, surgical planning, interventional procedures or treatment planning. These options include commercially available post-processing software.
The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.
This premarket notification covers Siemens syngo MultiModality Workplace (syngo MM WP), a syngo-based workplace that supports different modalities. syngo is a universal imaging platform based on Windows XP. syrgo MultiModality Workplace offers a comprehensive solution to view, optimize, process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information.
Due to special customer requirements based on the modality image type and the clinical focus, the syngo MultiModality Workplace can be configured with different combinations of clinical applications. syngo applications can be added to the multimodality workplace either individually or as clinically focused packages.
The syneo MultiModality Workplace is a medical diagnostic workplace for realtime viewing, manipulation, communication, and storage of medical images and data on exchange media.
The syrgo MultiModality Workplace can be configured as a stand-alone diagnostic review and post-processing workplace with a variety of syngo- or Windows XPbased software options, that are intended to assist the physician in diagnosis, surgical planning, interventional procedures or treatment planning. These options include commercially available post-processing software. The syngo MultiModality Workplace does not support the display of mammography images for diagnosis.
The syngo MultiModality Workplace will be marketed as a software only solution for the end-user (with recommended hardware requirements) or as a complete work station for the end-user (hardware and software package). It will be installed by Siemens service engineers. The syngo MultiModality Workplace described supports DICOM formatted images and information. The workplace is based on the Windows XP operating system.
This 510(k) submission for the Siemens syngo MultiModality Workplace (syngo MMWP) does not include a study proving device performance against acceptance criteria in the typical sense of a clinical or performance study with metrics like sensitivity, specificity, or reader agreement.
Instead, this submission is centered on demonstrating substantial equivalence to a previously cleared predicate device (syngo MultiModality Workplac (K052775) and MAGNETOM Systems with Expert-i option (K052423)). For general PACS (Picture Archiving and Communications System) software like the syngo MMWP, the "acceptance criteria" are primarily related to conforming to established standards, ensuring proper image display and manipulation, and maintaining data integrity, rather than diagnostic performance metrics.
Therefore, many of the requested points below cannot be directly extracted from the provided text, as the focus is on safety, effectiveness, and equivalence to existing technology.
Here's an breakdown based on the information available and the nature of this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
As a general PACS workstation for viewing, manipulating, communicating, and storing medical images, the “acceptance criteria” are primarily conformance to established standards and ensuring functional equivalence to the predicate. Specific quantitative diagnostic performance metrics are not typically required for a device of this classification.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Substantial Equivalence Claim) |
|---|---|
| Functional equivalence to predicate devices (K052775, K052423) | The syngo MultiModality Workplace has the "same intended use and similar technical characteristics" as the predicate devices and "performs as well." |
| Compliance with DICOM standards | The workplace "supports DICOM formatted images and information." |
| Risk management and safety | "Risk management is ensured via a risk analysis," with hazards controlled by software development, verification, and validation testing. Adheres to "recognized and established industry practice and standards" to minimize hazards. |
| Proper display, manipulation, communication, and storage of medical images | The device offers a "comprehensive solution to view, optimize, process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information." Supports "realtime viewing, manipulation, communication, and storage of medical images and data on exchange media." |
| Excludes mammography for diagnosis | Explicitly states: "The syngo MultiModality Workplace does not support the display of mammography images for diagnosis." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. Performance testing for a PACS workstation typically involves extensive internal verification and validation with a wide variety of anonymized clinical images rather than a single "test set" with a defined sample size for a specific clinical endpoint.
- Data Provenance: Not specified. Given it's a Siemens product developed in Germany, it's highly likely that testing data would include a mix of internal, international, and potentially U.S. clinical data, if specific clinical data were used, but the document does not elaborate. This type of submission relies more on functional testing and adherence to standards than a specific clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a diagnostic AI/CAD device requiring expert-established ground truth for clinical performance evaluation. The "ground truth" for a PACS workstation is determined by its ability to accurately display, process, and transmit medical images as per DICOM standards and clinical requirements, which relies on engineering and software validation, not expert medical adjudication of diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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
No. This is not an AI-assisted diagnostic device. It is a general PACS workstation. Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No specific "standalone algorithm performance" study is described because the device is an interactive workstation designed for human users. The performance is assessed in terms of its functionality in supporting human users, not as an autonomous diagnostic algorithm.
7. The type of ground truth used
Not applicable in the sense of expert consensus, pathology, or outcomes data for a diagnostic performance evaluation. The "ground truth" for this device relates to the fidelity and accuracy of image display, processing, and storage according to technical specifications and DICOM standards. This is verified through technical validation, not clinical ground truth.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning model development. This is a conventional software application (PACS).
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).