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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 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).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device: syngo Dynamics (Version VA40F) - Specifically, the Auto EF algorithm.

2. Sample Size and Data Provenance

• Test Set Sample Size: n = 150 cases.
• Data Provenance:
  • Country of Origin: U.S. (3 sites with geographic diversity from 2 different regions).
  • Retrospective/Prospective: Not explicitly stated, but the description "independent of the training data" and "representative of the intended use population" suggests it's likely retrospective data used for independent validation.

3. Number of Experts and Their Qualifications for Ground Truth

• Number of Experts: 2 experienced sonographers.
• Qualifications: "experienced sonographers". No specific years of experience or board certifications are mentioned.

4. Adjudication Method for the Test Set

The ground truth was established by two sonographers who "worked independently of each other and did not have access to Auto EF when establishing the ground truth." This implies that the initial ground truth was established independently. The text does not explicitly state if there was an adjudication method (e.g., 2+1, 3+1) if their measurements differed, or whether a consensus process was applied. It simply states they "worked independently."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted to assess how much human readers improve with AI vs. without AI assistance. The study focused on the standalone performance of the Auto EF algorithm against a ground truth established by human experts.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted for the Auto EF algorithm. The text states: "standalone performance testing for Auto EF was conducted to assess the performance of Auto EF compared to the ground truth (reference standard) established using conventional methods."

7. Type of Ground Truth Used

The ground truth for the Auto EF test set was established by expert consensus using a conventional manual method for Left Ventricular (LV) volumes and Ejection Fraction (EF). Specifically, the "Method of Disks" (MOD), also known as the Modified Simpson's Rule, was used by two experienced sonographers working independently.

8. Sample Size for the Training Set

The sample size for the training set is not provided in the given text. It only states that the test data (n=150) are "independent of the training data used for the training of the Auto EF algorithm."

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

The method for establishing the ground truth for the training set is not explicitly stated in the provided text. It only mentions that the test data was independent of the training data.

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