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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.

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.

The use of syngo Dynamics is focused on cardiac ultrasound (echocardiography), angiography (x-ray), cardiac nuclear medicine (NM), CT and MR studies that cover both adult and pediatric medicine. Also supported is vascular ultrasound and ultrasound in Obstetrics/Gynecology and Maternal Fetal Medicine (fetal echocardiography during pregnancy).

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 provides various semi-automated anatomical visualization tools.

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).

In the United States, monitors (displays) should not be used for diagnosis, unless the monitor (display) has specifically received 510(k) clearance for this purpose.

This FDA 510(k) clearance letter pertains to syngo Dynamics (Version VA41D), a Medical Image Management and Processing System (MIMPS). While the document broadly discusses the device's substantial equivalence to a predicate device (syngo Dynamics VA40F) and its general functionalities, the only specific AI/ML-enabled function for which performance data and acceptance criteria are detailed is the Auto EF algorithm for calculating left ventricular ejection fraction from ultrasound images.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based specifically on the Auto EF algorithm information provided:

1. Table of Acceptance Criteria and Reported Device Performance (Auto EF Algorithm)

The document states that "Additional acceptance criteria were defined with a total of 12 predetermined acceptance criteria," but only explicitly details one primary statistical criterion and provides summarized performance for a few other aspects.

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

• Sample Size for Test Set: n = 150 cases.
• Data Provenance: The test data originated from 3 sites in the U.S., representing geographic diversity from 2 different regions. The data was collected retrospectively, as it was independent of the training data. The document states it is "representative of the intended use population for Auto EF" and balanced for gender, covering ages 21-93 years and BMIs 16.5-48.8. It also included data from three ultrasound manufacturers (Philips, GE, and Siemens).

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

• Number of Experts: 2 experienced sonographers.
• Qualifications: "experienced sonographers." Specific details regarding their years of experience or board certifications are not provided in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: The two sonographers worked independently to establish the ground truth. There is no mention of a formal adjudication process (e.g., 2+1, 3+1), arbitration by a third expert, or a consensus meeting after independent readings. They "did not have access to Auto EF when establishing the ground truth."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The document explicitly states, "No clinical studies were carried out for syngo Dynamics (Version VA41D). All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device." The evaluation focused on the algorithm's performance against ground truth, not on human reader performance with or without AI assistance.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm-Only) Performance Study

• Standalone Study: Yes. The performance validation of the Auto EF algorithm was conducted in a standalone manner. The "Auto EF results with the subject device" were compared directly against the established ground truth. The algorithm processed the images and generated biplane EF values without human intervention in the calculation process, although the system allows users to "review, edit or reject the results."

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus with a conventional manual method based on the "Method of Disks" (MOD), also known as the Modified Simpson's Rule. The ground truth was established by two independent sonographers calculating left ventricular volumes and ejection fraction.

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated. The document mentions the algorithm was "re-trained with more training data" compared to the predicate device, but does not provide a specific number.

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

• Training Set Ground Truth Establishment: Not explicitly detailed. The document only states that the "LV auto contouring algorithm has been updated with pre-training and additional annotated training data." It does not specify the method (e.g., expert consensus, manual contouring) or the number/qualifications of experts involved in annotating the training data. However, given that the test set ground truth was established by sonographers using the Method of Disks, it is highly probable that a similar methodology was used for the training data annotation.

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