(27 days)
syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
This premarket notification covers Siemens' enhanced system syngo® Dynamics, version 5.0.
syngo® Dynamics is a digital image management system that includes a DICOM server. This system receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. The system has workplaces that can be used to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.
synad® Dynamics provides advanced reporting features, including cardiology oriented features for review and analysis of x-ray angiographic images, and the capability to host additional 3rd party software applications.
syngo® Dynamics is a software device that is shipped as a turn key system with pre-installed software on common, off-the-shelf OEM computer hardware. syngo® Dynamics is installed by Siemens service engineers.
Version 5.0 contains extended reporting features to address a broader range of diagnostic imaging needs and other added capabilities for Radiology and Obstetric imaging, while continuing to provide special focus on Cardiology needs including echocardiography, x-ray anqiography, and image storage for nuclear medicine.
synqo® Dynamics, version 5.0 also offers an optional "software only" workplace with full viewing and report generation, which will be delivered on CD-ROM and installed by the end user on his own computer hardware.
Here's an analysis of the provided 510(k) summary for syngo® Dynamics (version 5.0), focusing on acceptance criteria and supporting study details:
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for syngo® Dynamics (version 5.0) does not explicitly state specific acceptance criteria or report direct device performance metrics in a quantitative manner.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The core argument for safety and effectiveness is that syngo® Dynamics does not introduce any new potential safety risks and performs as well as the commercially available predicate devices.
Therefore, for this particular submission, the "acceptance criteria" can be implicitly understood as:
- Functional Equivalence: The device performs the same intended functions (acceptance, transfer, display, storage, archive, manipulation of digital medical images, quantification, and report generation) as the predicate devices.
- Safety Equivalence: The device does not introduce new safety risks compared to the predicate devices.
- Compliance with Standards: The device adheres to recognized and established industry practices and standards.
Since no specific performance metrics (e.g., accuracy, speed, uptime) are provided in the summary, a table of reported device performance is not possible to generate from this document.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on establishing substantial equivalence through a comparison of technological characteristics with predicate devices and adherence to risk management processes, rather than reporting on a specific performance study with a test dataset.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Since no specific test set or performance study is detailed, there is no information provided regarding the number of experts, their qualifications, or their role in establishing ground truth.
4. Adjudication Method for the Test Set
As no specific test set or performance study is described, there is no information about any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The 510(k) summary does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The focus is on substantial equivalence to predicate devices, not on direct comparison of human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
The 510(k) summary describes syngo® Dynamics as a "digital image management system," a "software device" that includes features like review, editing, manipulation, quantitative/qualitative data generation, and diagnostic reports. It also mentions an "optional 'software only' workplace with full viewing and report generation."
However, it does not contain information about a standalone (algorithm only) performance study. The device itself is a PACS system designed to be used by humans for managing and interpreting medical images. There's no mention of an embedded AI algorithm whose standalone performance was evaluated independently of human interaction.
7. Type of Ground Truth Used
Given the nature of the submission (substantial equivalence for a PACS system), and the lack of a detailed performance study with a test set, no specific "ground truth" (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for validation. The validation hinges on functional equivalence to predicates and adherence to safety standards.
8. Sample Size for the Training Set
The 510(k) summary does not specify any training set size as it does not describe a machine learning or AI algorithm development that would typically involve a training phase.
9. How Ground Truth for the Training Set was Established
Since no training set is mentioned in the context of an algorithm, there is no information on how ground truth was established for a training set.
§ 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).