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The software comprising the syngo.MR post-processing applications are postprocessing 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 Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images.

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

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

syngo.MR BreVis is a software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. syngo.MR BreVis supports evaluation of dynamic MR data. Depending on the region of interest, contrast agents may or may not be used.

syngo.MR BreVis automatically registers serial patient motion to minimize the impact of patient motion and visualizes different enhancement characteristics in those areas that are within the scope of the indications for use of MRI FDA approved contrast agents (parametric image maps). Furthermore, it performs other user-defined postprocessing functions such as image subtractions, multiplanar reformats and maximum intensity projections. The resulting information can be displayed in a variety of formats. including a parametric image overlaid onto the source image, syngo.MR BreVis can also be used to provide measurements of the diameters, areas and volumes.

Furthermore syngo.MR BreVis can evaluate the uptake characteristics of segmented tissues that are within the scope of the indications for use of MRI FDA approved contrast agents. syngo.MR BreVis is optimized for viewing breast MR studies, and it also displays images from a number of other imaging modalities, like digitized mammographic images.

The images by other imaging modalities displayed with syngo.MR BreVis must not be used for primary diagnostic interpretation. syngo.MR BreVis also includes the option to add annotations based on the American College of Radiology's BI-RADS (Breast Imaging Reporting and Data System). When interpreted by a skilled physician, syngo.MR BreVis provides information that may be useful in diagnosis. Patient management decisions should not be made based solely on the results of syngo.MR BreVis analysis.

syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and syngo.mMR General are post-processing software / applications to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device, syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and synqo.mMR General are syngo.via-based software that enable structured evaluation of MR images.

The provided text is a 510(k) summary for the syngo.MR post-processing software (Version SMRVA16B). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than presenting an extensive study proving performance against specific acceptance criteria.

Therefore, the document does not contain the detailed information required to fully answer all points of your request, such as specific acceptance criteria for a new clinical study, the reported device performance against those criteria, sample sizes for test sets, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance details, training set information, or how ground truth for training was established.

Instead, the submission argues that the new device has "same technological characteristics and functionalities as the predicate device, and do not introduce any new issues of safety or effectiveness." The "study" here is essentially a comparison to the predicate device.

However, I can extract the following based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document as a new clinical study with specific acceptance criteria was not conducted for this 510(k) submission. The entire submission is built on the premise of substantial equivalence to a predicate device.

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

• Sample Size for Test Set: Not applicable. No new clinical test set was used to establish performance against new acceptance criteria. The submission relies on the predicate device's clearance.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth for a new test set was not established for this submission.

4. Adjudication method for the test set:

• Not applicable.

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 comparative effectiveness study was done for this submission. The device is a post-processing software, not specifically an AI-driven diagnostic aid in the context of an MRMC study to compare reader performance with and without AI assistance.

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

• Not explicitly stated as a standalone performance study with specific metrics. The software's functionality is described as "post-processing software for viewing, manipulating, and evaluating" images, implying it's a tool for human readers rather than making independent diagnostic decisions. The document states, "Patient management decisions should not be made based solely on the results of syngo.MR BreVis analysis."

7. The type of ground truth used:

• Not applicable for a new study. The safety and effectiveness are based on demonstrating substantial equivalence to a previously cleared device. For the predicate device, the regulatory clearance would have been based on appropriate clinical data and ground truth (which could be expert consensus, pathology, or outcomes data depending on the device).

8. The sample size for the training set:

• Not applicable. This document describes a 510(k) submission for new versions/modules of existing software, relying on substantial equivalence, not a de novo clearance requiring a new AI model with a training set.

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

• Not applicable.

Explanation of the "Study" and "Acceptance Criteria" in this Context:

In a 510(k) submission based on "substantial equivalence," the "study" is less about generating new performance data against novel acceptance criteria and more about demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The "acceptance criteria" here implicitly refer to the regulatory standards and performance of the predicate device, K130749 (syngo.MR Post-Processing Software Version SMRVA16A), which was cleared on August 20, 2013. The manufacturer's claim is that the updated software "do not raise new questions of safety or effectiveness" and has "same technological characteristics and functionalities as the predicate device" despite having "greater capabilities."

Therefore, the "proof" the device meets acceptance criteria is the argument that it is substantially equivalent to a device that has already met the FDA's safety and effectiveness requirements.

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