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The software comprising the syngo.MR post-processing applications are post-processing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.

syngo.MR General is a syngo based post-processing software for viewing, manipulating, and evaluating MR images.

syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating, and evaluating MR cardiac images.

syngo.MR Vascular is a syngo based post-processing software for viewing, manipulating, and evaluating MR vascular images.

syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular are post-processing software / applications to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device. syngo.MR General; syngo.MR Cardiology and syngo.MR Vascular is syngo.via-based software that enable structured evaluation of MR images.

syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular comprise the following (please refer to Table 1).

syngo.MR General: covered single and engines applications syngo.MR Reading enables reading of 2D, 3D and 4D MR data. syngo.MR Composing (optional) is an offline application for creation of full-format images from overlapping MR volume data sets acquired at multiple stages. syngo.MR General Engine (optional) extends syngo.via by adding software for professional and routine MR radiology usage. It includes workflows for dedicated MR examinations that load and structure examination results automatically into layouts including user support to make sure that no data is missed. syngo.MR General Engine contains several MR Radiology Workflows, MR Cardio-Vascular Workflows and MR Basic Evaluation features.

syngo.MR Cardiology: syngo.MR Cardiac 4D Ventricular Function enables 4D ventricular function evaluation and processes MR cine images of the heart and generates quantitative results for physicians in the diagnostic process. syngo.MR Cardiac Flow enables cardiac flow evaluation and processes velocity-encoded MR images to evaluate blood flow dynamics e.g. in the heart and the great vessels. The application generates quantitative results for physicians in the diagnostic process. syngo.MR Cardio Engine contains: - syngo.MR Cardiac 4D Ventricular Function; - syngo.MR Cardiac Flow.

syngo.MR Vascular: syngo.MR Vascular Analysis enables assessment / quantification of general vascular pathologies

The provided text is a 510(k) summary for the syngo.MR Post-Processing Software (Version SMRVA16A), which includes syngo.MR General, syngo.MR Cardiology, and syngo.MR Vascular. This document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and a comprehensive performance evaluation of the device itself.

Based on the provided text, the following information can be extracted or deduced regarding the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the syngo.MR Post-Processing Software. Instead, it claims substantial equivalence to predicate devices. The "performance" assessment is framed around the device's functionality being similar to or an improvement upon the predicate devices without introducing new safety or effectiveness issues.

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

The document does not describe a specific "test set" in the context of an independent performance study with a defined sample size. The substantial equivalence argument relies on the inherent characteristics of the software and its intended use, which are aligned with already cleared devices. There is no mention of a particular dataset (e.g., patient MR images) being used for a formal performance evaluation to establish acceptance criteria for this specific 510(k) submission.

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

Since no specific test set and associated ground truth establishment study are described, there is no information on the number or qualifications of experts involved in such a process.

4. Adjudication Method for the Test Set

As there is no described test set requiring ground truth establishment, there is no mention of an adjudication method.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The submission focuses on device equivalence, not on comparing reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study is described. The device is a post-processing software intended for human use (viewing, manipulating, evaluating), implying human-in-the-loop operation.

7. Type of Ground Truth Used

Given the nature of the submission (substantial equivalence for post-processing software), the concept of "ground truth" in the context of, for example, disease detection or quantification accuracy, is not directly addressed through a performance study. The ground truth for this type of device's "performance" is implicitly tied to its ability to display, manipulate, and facilitate evaluation of MR images in a manner consistent with existing, cleared technology, and in compliance with relevant standards.

8. Sample Size for the Training Set

No information is provided regarding a training set or its sample size. This type of software, as described, is not an AI/ML algorithm that typically requires a large training set in the way a diagnostic AI algorithm would. It is a tool for post-processing and visualization.

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

As there is no described training set, there is no information on how its ground truth would have been established.

Summary of Approach in this 510(k):

This 510(k) submission primarily relies on establishing substantial equivalence to existing legally marketed predicate devices. The arguments revolve around:

• Similar Indications for Use: The devices serve similar purposes for viewing and evaluating MR images.
• Similar Technological Characteristics and Functionalities: The core functions of post-processing, viewing, manipulating, and evaluating are comparable to the predicate devices.
• No New Safety or Effectiveness Questions: The changes (e.g., updated platform, enhancements) do not introduce novel risks or raise new concerns.
• Compliance with Standards: Adherence to recognized medical device standards (e.g., ISO 14971:2009 for risk management, IEC, ISO, NEMA standards).

The document does not detail a prospective clinical study or a rigorous retrospective performance study with defined acceptance criteria and statistical analysis to "prove" the device meets those criteria in a quantitative sense as might be typical for a novel diagnostic algorithm. Instead, the proof is an argument of similarity and compliance with established regulatory frameworks for predicate devices.

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