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syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.

syngo Dynamics supports clinicians by providing post image processing functions for image manipulation, and/or quantification that are intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within the healthcare institution's network.

syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.

Device Description

syngo Dynamics is a software only medical device which is used with common IT hardware. Recommended configurations are defined for the hardware required to run the device, and hardware is not considered as part of the medical device.

syngo Dynamics is intended to be used by trained healthcare professionals in a professional healthcare facility to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

syngo Dynamics is a digital image display and reporting system with flexible deployment - it can function as a standalone medical device that includes a DICOM Server or as an integrated module within an Electronic Health Record (EHR) System with a DICOM Archive that receives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. There are three deployments: Standalone, EHR/EHS Integrated, and Multi-Modality Cardiovascular (MMCV). MMCV deployment functions as a standalone medical device with capability of natively support 2D and 3D CT and MR image types.

syngo Dynamics is based on a client-server architecture. The syngo Dynamics server processes the data from the connected imaging modalities, and stores data and images to a DICOM server and routes them for permanent storage, printing, and review. The client provides the user interface for interactive image viewing, reporting, and processing; and can be installed on network connected workstations.

syngo Dynamics offers multiple access strategies: A Workplace that provides full functionality for reading and reporting: A Remote Workplace that provides additionally compressed images with access to full fidelity images for reading and reporting; and a browser based WebViewer that provides access to additionally compressed images and reports from compatible devices (including mobile devices).

AI/ML Overview

The provided document describes a 510(k) premarket notification for syngo Dynamics (Version VA40E), a medical image management and processing system. The submission aims to demonstrate substantial equivalence to a predicate device, syngo Dynamics VA30 (K171053).

Based on the document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note that the document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for specific performance metrics (e.g., sensitivity, specificity, accuracy) because it is a substantial equivalence submission for a software update rather than a new device that needs to establish clinical efficacy from scratch. The acceptance criteria are implicitly met by demonstrating that the new version performs as well as or better than the predicate device, or that any changes do not introduce new safety or effectiveness concerns.

The performance is primarily evaluated through non-clinical testing (verification and validation) to confirm that the updated software continues to function as intended and maintains the performance of the predicate device, especially considering the added functionalities.

Feature/Attribute Tested	Acceptance/Equivalency Standard	Reported Device Performance/Conclusion
Indications for Use	Equivalent to predicate device (syngo Dynamics VA30), with minor updates not fundamentally changing the device's purpose.	The Indications for Use for syngo Dynamics (Version VA40E) are fundamentally the same as the predicate device. Updates primarily exclude functions like "storage and display" which no longer fall under FDA's medical device definition. No new specific disease or patient population indications. Shared contraindication (not for digital mammography in U.S.).
Architecture	Same as predicate (Client-server).	Same (Client-server).
Supported Modalities	Supported modalities should not introduce new safety/effectiveness concerns compared to predicate, and ideally enhance/extend usability without changing the intended purpose.	Subject device added support for a few DICOM modalities (CT, MR, SC, PET via Corridor4DM) compared to the predicate. These additions enhance and extend conditions for use but do not impact the purpose or actual use of the device. (Note: These are identical to those in the reference device syngo.via VB40A, K191040).
Image Communication	Standard communication protocols, equivalent to predicate.	Equivalent. Uses TCP/IP, DICOM, HL7, HTTP(S). The predicate used HTTP, the subject uses HTTP(S). All are standard protocols.
Image Data Compression	Lossless and lossy compression methods, equivalent to predicate.	Equivalent. Both use lossless (factor 2-3) and lossy (JPEG/MP4) compression. The only difference is the file format for lossy compression (MP4 explicitly mentioned for subject device).
Imaging Algorithms	Equivalent or improved without introducing new safety/effectiveness concerns.	Subject device uses the same imaging algorithms as the predicate, with additional four algorithms (Multiplanar reconstruction (MPR), Maximum and Minimum Intensity Projection (MIP/MinIP), Volume Rendering Technique (VRT)). These additions are identical to those in the reference device syngo.via VB40A.
Quantitative Algorithms	Equivalent or improved without introducing new safety/effectiveness concerns.	Subject device added three quantitative algorithms (Distance line, Angle, Volume) from the predicate device (which only had Pixel Size Evaluation). These additions are identical to those in the reference device syngo.via VB40A.
Decision Support	Same as predicate (ability to interface with third-party rules engine).	Same with the predicate device.
Reporting	Equivalent to predicate's reporting capabilities.	Equivalent. Both offer customizable DICOM Structured Reporting and Collaborative reporting. "Web reporting" in predicate was replaced with "Remote reporting" via Remote Workplace in the subject device, which is considered equivalent.
Access Strategies	Similar to predicate's access methods.	Similar. "Portal Image Review" in predicate replaced by "Remote Workplace" and "WebViewer" in subject.
Mobile Device Support	Equivalent web-client for non-diagnostic read-only access.	Equivalent. Both use web client for read-only access (WebViewer for subject, Common Login/Portal Image Review for predicate) on mobile devices for non-diagnostic use.
Long Term Archive	Same archiving capabilities.	Same. Both provide long-term archive and retrieval of DICOM studies to/from VNA or HSM systems.
Hardware	Software-only option for server/workstation, with recommended requirements.	Same. Software-only. Hardware not part of medical device, but must meet recommended requirements.
Virtualization	Same virtualization capabilities.	Same. Provides virtualization of server and client machines.
Operating System	Updated OS versions without introducing new safety/effectiveness concerns.	Equivalent. Subject device uses updated versions of Microsoft Windows Server and Windows 10 client OS compared to older versions in the predicate.
Deployment Strategy	Similar to predicate, potentially with added configurations that are equivalent to reference device.	First two deployments (standalone and EHR/EHS Integrated) are equivalent. The third deployment (Multi-modality cardiovascular) uses technology identical to the reference device syngo.via VB40A (K191040), particularly for CT/MR viewing, ensuring equivalency.
Conformance to Standards	Adherence to recognized consensus standards.	Claims conformance to NEMA PS 3.1-3.20 (2016), ISO IEC 10918-1 (1994), IEC 62366-1 (2020), ISO 14971 (2019), IEEE Std 3333.2.1-2015, IEC 62304 (2015), IEC TR 80001-2-2 (2012), IEC 82304-1 (2016).
Software Verification & Validation	Conformance to FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) and cybersecurity requirements.	Documentation included for software of a Moderate Level of Concern. Non-clinical testing conducted. Evidence demonstrates conformance with special controls. Cybersecurity considerations addressed to prevent unauthorized access, modification, misuse, etc. Risk Analysis (ISO 14971) completed, risk control implemented, and testing results support that all software specifications met acceptance criteria. Testing for verification and validation was found acceptable in support of determining similarities to the predicate/previously cleared device.
Overall Safety and Effectiveness	Safe and effective as the predicate, introducing no new safety or effectiveness concerns.	The device is safe, effective, and performs as well as the predicate device. It does not introduce any new significant potential safety risks and is similar to the predicate device. The output is evaluated by clinicians, providing for sufficient review to identify and intervene in case of malfunction.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not explicitly mentioned in terms of number of cases or studies. The submission states that "All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device." This implies functional testing, integration testing, and performance testing against defined specifications rather than testing with a "test set" of patient data in a clinical trial context.
Data Provenance: Not applicable, as no clinical studies with patient data were conducted. The testing involved non-clinical verification and validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided because no clinical studies were conducted, and therefore, no "ground truth" was established by experts for a test set of clinical cases. The device is for image management and processing, and its performance is assessed through technical verification and validation, ensuring it functions correctly and aligns with the predicate device.

4. Adjudication Method for the Test Set

Not applicable as no clinical test set requiring expert adjudication was used.

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, an MRMC comparative effectiveness study was not done. The device, syngo Dynamics (Version VA40E), is a medical image management and processing system, not an AI-assisted diagnostic tool designed to directly improve human reader performance in interpreting images. It provides functionalities for image manipulation, quantification, review, and reporting.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document implies that standalone software verification and validation were performed for the syngo Dynamics (Version VA40E) software, as it is a "software only medical device." The tests assessed the functionality of the device itself (e.g., image processing algorithms, communication protocols, reporting features) to ensure it meets specifications, which is a form of standalone performance assessment. However, it's not a standalone diagnostic performance study in the sense of a deep learning algorithm detecting disease.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Again, this is not explicitly stated as no clinical studies establishing diagnostic performance with a ground truth were conducted. For non-clinical software testing, the "ground truth" would likely be the expected output or behavior validated against established functional requirements, design specifications, and relevant industry standards (e.g., DICOM standard conformance for image handling).

8. The Sample Size for the Training Set

Not applicable. The device is a software system for image management and processing, not a machine learning model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of software.

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