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syngo Dynamics is an image and information system intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including review, analysis, quantification and reporting.

As a Cardiology PACS and information system, syngo Dynamics supports the physician in interpretation and evaluation of examinations within healthcare institutions, in particular, in Cardiology. Obstetrics and Gynecology or other departments.

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

syngo Dynamics VA30, is a digital image display and reporting system. This system can function as a standalone medical device that includes a DICOM server or as an integrated module within and 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. The syngo Dynamics system provides components that can be used to review, edit and manipulate image data, as well as to generate quantitative data, qualitative date and diagnostic reports. syngo Dynamics VA30 also provides advanced reporting support for cardiology, OB/GYN, MFM (maternal fetal medicine) and vascular ultrasound studies.

syngo Dynamics is a software only medical device. Recommended configurations are defined for the hardware required to run the device. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission.

syngo Dynamics is based on a client-server architecture. The server processes the data from the connected imaging modalities. The client provides the user interface for interactive image viewing and processing and can be installed on remote, network connected, workstation machines or through industry standard virtualization software.

The provided document is a 510(k) summary for the medical device "syngo® Dynamics Version VA30," a Picture Archiving and Communication System (PACS). This document does not describe any quantitative acceptance criteria or a study proving that the device meets such criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (syngo® Dynamics VA10A) based on functional performance, technical characteristics, and adherence to relevant standards.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

• No Diagnostic Performance Claims: The device is a PACS system designed for image management, review, analysis, quantification, and reporting. It is explicitly stated that "syngo Dynamics is not intended to be used for displaying of digital mammography images for diagnosis in the U.S." This implies that the device itself is not making diagnostic claims that would require clinical performance metrics like sensitivity or specificity.
• Focus on System Functionality and Safety: The "acceptance criteria" and "study" described are primarily related to software verification and validation, cybersecurity, and risk management, ensuring the system functions as intended and is safe within its defined scope.

However, based on the information provided, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

Since there are no diagnostic performance metrics (e.g., sensitivity, specificity) for this PACS device, the "acceptance criteria" can be inferred from the non-clinical testing and conformance to standards. The "reported device performance" refers to the successful completion of these tests and compliance.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly mentioned. The document states "All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device." This implies internal testing with data relevant to PACS functionalities (e.g., various image formats, sizes, and data types to ensure proper storage, display, and manipulation).
• Data Provenance: Not explicitly mentioned. Given it's a PACS system for various medical images (Ultrasound, XA, DX, DR, PET, Nuclear Medicine), the test data would likely be representative medical images and related patient information used for internal V&V. The data used is almost certainly retrospective as it's for non-clinical V&V, not a prospective clinical study. No country of origin is specified for test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. As no clinical diagnostic performance study was conducted where "ground truth" for disease states would be required, this information is not relevant or provided. The "truth" for this device's testing would be whether its software functions correctly, adheres to DICOM standards, correctly displays images, and performs specified manipulations/quantifications as per its design specifications.

4. Adjudication method for the test set:

• Not Applicable. Since there was no clinical diagnostic performance study requiring expert interpretation of medical images to establish a ground truth, no adjudication method (like 2+1 or 3+1) was applicable or mentioned.

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 MRMC study was done. The device is a PACS system, not an AI-powered diagnostic algorithm intended to assist human readers in interpretation or alter their diagnostic performance. It is a tool for image and information management. The document explicitly states: "No clinical studies were carried out for syngo Dynamics VA30."

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

• Not Applicable. The device is a PACS system; it doesn't have a "standalone algorithm" in the sense of a diagnostic AI performing automated interpretations. Its performance is intrinsically linked to its functionality as an imaging and information management system, which supports human users. The "software verification and validation" tests its standalone functional capabilities.

7. The type of ground truth used:

• For this device, "ground truth" pertains to the correct functioning of the software according to its specifications and adherence to standards. It would involve comparing the system's output (e.g., displayed image, stored data, reported measurement) against expected, known correct values or behaviors established by engineering specifications, DICOM standards, or manual verification. It's not expert consensus, pathology, or outcomes data as it's not a diagnostic device making clinical claims.

8. The sample size for the training set:

• Not Applicable. This device is a PACS system, not a machine learning or AI algorithm that requires a "training set" of data for model development. Its development follows traditional software engineering principles.

9. How the ground truth for the training set was established:

• Not Applicable. As no training set is used for this type of software, this question is not relevant.

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