(14 days)
syngo® Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.
It supports the physician in diagnosis and treatment planning.
For primary image diagnosis in mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM "For Presentation" images must be used. Also only monitors which received FDA clearance for mammography must be used. syngo® Imaging also supports storage and archiving of DICOM Structured Reports.
In a comprehensive imaging suite syngo® Imaging integrates Radiology Information Systems (RIS) to enable customer specific workflows.
Enhanced syngo® Imaging workplaces use a variety of advanced postprocessing applications.
This premarket notification covers Siemens' enhanced PACS system syngo® Imaging, version V31.
syngo® Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.
It supports the physician in diagnosis and treatment planning.
For primary image diagnosis in mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM "For Presentation" images must be used.
syngo® Imaging also supports storage and archiving of Structured DICOM Reports.
In a comprehensive imaging suite syngo® Imaging integrates Radiology Information Systems (RIS) to enable customer specific workflows, especially by supporting the role based and context sensitive RIS portals (such as "Portal Radiologist").
Enhanced syngo® Imaging workplaces use a variety of advanced post processing applications.
The system is a "hardware independent" solution to be distributed either as software only or combined with common IT hardware which must comply to predefined minimum hardware requirements.
The version V31 contains 2 improvements on front end for usability, such as query enhancements and calibration improvements.
The provided 510(k) summary for Siemens' syngo® Imaging (version V31) is a software-only system described as a Picture Archiving and Communication System (PACS). It is intended to display, process, read, report, communicate, distribute, store, and archive digital radiological images, including digital mammography images. It supports physicians in diagnosis and treatment planning.
Crucially, this 510(k) submission does not contain a study presenting specific acceptance criteria or device performance data in the format of a clinical trial or performance study. Instead, it is a Special 510(k), indicating a modification to an already cleared device. The primary method for proving safety and effectiveness in such cases is demonstrating substantial equivalence to previously cleared predicate devices, by showing that the new device does not introduce new potential safety risks and performs as well as the predicates.
Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
As this is a Special 510(k) focused on substantial equivalence to predicate devices for a PACS system, there are no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) or performance metrics for a diagnostic task reported in the document. The acceptance for a PACS system is generally tied to its ability to reliably perform its stated functions (display, process, store, etc.) and integrate with existing systems, rather than diagnostic accuracy metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicates: The device should perform all the intended functions (image display, processing, reporting, storage, archiving) as well as the predicate devices. | The document states: "Siemens is of the opinion that syngo® Imaging does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices." |
| Safety and Effectiveness: No new potential safety risks introduced. | Risk management (risk analysis, software development, verification and validation testing) is stated to ensure safety and effectiveness. Device labeling contains necessary cautions and warnings. |
| Digital Mammography Image Handling: For primary image diagnosis in mammography, only uncompressed or non-lossy compressed images and pre-processed DICOM "For Presentation" images must be used. Only FDA-approved monitors for mammography must be used. | The device explicitly states adherence to these conditions for mammography. Specific FDA-approved monitors are mentioned (e.g., Siemens AG: SMVD 21500 or DjSB-2103-D-5MP - K043122). |
| DICOM Conformance: Data Management can be used as a DICOM-Archive (LTS Long-term Storage) in accordance with the DICOM Conformance Statement. | Explicitly stated. |
| Integration with RIS: Integration with HL7- / DICOM-compatible RIS (IHE Year 5) to enable consistent workflows. | Explicitly stated. |
2. Sample Size Used for the Test Set and Data Provenance:
No specific test set or data provenance is mentioned as there isn't a performance study evaluating diagnostic accuracy. The "test set" for a PACS system mainly involves verification and validation testing to ensure software functionality, interoperability, and adherence to DICOM standards. These tests are typically conducted internally by the manufacturer and are not detailed in the 510(k) summary concerning specific image datasets or patient cohorts.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. As there is no diagnostic performance study, there's no "ground truth" to establish for a test set in the context of expert review of images for disease detection.
4. Adjudication Method for the Test Set:
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is typically performed for AI or CAD devices that directly aid in diagnostic interpretation, not for a general PACS system like syngo® Imaging.
6. If a Standalone Study Was Done:
No, a standalone (algorithm only without human-in-the-loop performance) study was not done for diagnostic accuracy. The device itself is a PACS, which is inherently a human-in-the-loop system designed to present images for human interpretation.
7. The Type of Ground Truth Used:
Not applicable. For a PACS system, "ground truth" relates to the correct functioning of the software, adherence to standards, and successful image archiving/retrieval, not to a diagnostic outcome or pathology finding from a specific image dataset.
8. The Sample Size for the Training Set:
Not applicable. This device is a PACS, not an AI or CAD system that would typically undergo a training phase on a large dataset of medical images.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning model.
In summary, the 510(k) K081734 for syngo® Imaging (version V31) is a Special 510(k) demonstrating substantial equivalence to previously cleared PACS devices. It focuses on proving that the enhanced version maintains safety and effectiveness and performs comparably to its predicates, particularly highlighting compliance with conditions for digital mammography image handling and general PACS functionalities. It does not present a clinical performance study with specific diagnostic acceptance criteria, test sets, or ground truth establishment because it's a PACS, not a diagnostic AI/CAD system.
§ 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).