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syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra.

Applications are syngo svnao.MR based post-processing The software/applications to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images.

The syngo.MR Applications is a combination of eight (8) former separately cleared medical devices which are now handled as features / functionalities within syngo.MR Applications.

These functionalities are combined unchanged compared to their former cleared descriptions; of course some minor enhancements and improvements are made. The syngo.MR Applications are syngo.via based MR data viewing, processing and reading software allowing MR image evaluation in a structured way and supporting convenient reading and / or evaluation of MR images and data.

The provided text describes the regulatory clearance of a medical device called "syngo.MR Applications" and discusses its safety and effectiveness in comparison to predicate devices. However, it does not contain a detailed study report with specific acceptance criteria, reported device performance metrics, sample sizes, or ground truth establishment methods for a specific algorithm's performance.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to already cleared devices rather than providing a detailed performance study for a novel algorithm.

Therefore, many of the requested details about acceptance criteria and a study proving those criteria are not present in the provided text.

Based on the available information, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated for specific algorithmic performance. The document focuses on showing that the combined functionalities of syngo.MR Applications maintain an "equivalent safety and performance profile" to predicate devices.
• Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity, specificity, AUC) are provided for any specific functionality of the syngo.MR Applications software. The document mentions "minor improvements and enhancements of the existing functionalities," such as improved functional analysis in MR Cardiac Analysis workflow, a pen tool for editing LV and RV contours, and other UI/UX improvements, but no objective performance data is given for these.

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

• Not provided. The document does not describe any specific test set used to evaluate the performance of an algorithm within syngo.MR Applications.

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

• Not provided. Since no specific performance study on a test set is detailed, information about ground truth establishment or experts is absent.

4. Adjudication method for the test set

• Not provided.

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 is not mentioned. The document focuses on the software's capabilities for viewing, manipulating, evaluating, and analyzing images, and its substantial equivalence to predicate devices, not on a human-in-the-loop performance study or AI assistance.

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

• No standalone algorithmic performance study is explicitly described with quantitative results. The document describes "post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra." While this implies algorithmic processing, no specific, isolated algorithm performance metrics are reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not provided.

8. The sample size for the training set

• Not provided.

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

• Not provided.

In summary: The provided document is a regulatory submission affirming substantial equivalence of a software suite for image processing to existing cleared devices. It describes the functionalities of the software and references compliance with various standards (ISO 14971, IEC 62304, DICOM), but it does not contain the detailed performance study data (acceptance criteria, specific metrics, sample sizes, ground truth methods) that would be expected for a novel AI/ML algorithm's validation. The "device" in this context is a comprehensive software platform with various post-processing functionalities, not a single, measurable AI algorithm with specific performance claims in the way requested by the prompt.

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