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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.

syngo.MR Applications is a software only Medical Device consisting post-processing applications/workflows used for viewing and evaluating the designated images provided by a MR diagnostic device. The post-processing applications/workflows are integrated with the hosting application syngo.via, that enables structured evaluation of the corresponding images

The provided FDA 510(k) clearance letter and summary for syngo.MR Applications (VB80) indicate that no clinical studies or bench testing were performed to establish new performance criteria or demonstrate meeting previously established acceptance criteria. The submission focuses on software changes and enhancements from a predicate device (syngo.MR Applications VB40).

Therefore, based solely on the provided document, I cannot create the requested tables and information because the document explicitly states:

• "No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device."
• "No bench testing was required to be carried out for the product."

The document details the following regarding performance and acceptance:

• Non-clinical Performance Testing: "Non-clinical tests were conducted for the subject device during product development. The modifications described in this Premarket Notification were supported with verification and validation testing."
• Software Verification and Validation: "The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device Syngo.MR Applications during product development... The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence."
• Conclusion: "The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use."

This implies that the acceptance criteria are related to the functional specifications and performance of the software, as demonstrated by internal verification and validation activities, rather than a clinical performance study with specific quantitative metrics. The new component, "MR Prostate AI," is noted to be integrated without modification and had its own prior 510(k) clearance (K241770), suggesting its performance was established in that separate submission.

Without access to the actual verification and validation reports mentioned in the document, it's impossible to list precise acceptance criteria or detailed study results. The provided text only states that "all the software specifications have met the acceptance criteria."

Therefore, I can only provide an explanation of why the requested details cannot be extracted from this document:

Explanation Regarding Acceptance Criteria and Study Data:

The provided FDA 510(k) clearance letter and summary for syngo.MR Applications (VB80) explicitly state that no clinical studies or bench testing were performed for this submission. The device (syngo.MR Applications VB80) is presented as a new version of a predicate device (syngo.MR Applications VB40) with added features and enhancements, notably the integration of an existing AI algorithm, "Prostate MR AI VA10A (K241770)," which was cleared under a separate 510(k).

The basis for clearance is "non-clinical performance data" and "software validation data" demonstrating that the subject device performs comparably to and is as safe and effective as the predicate device. The document mentions that "all the software specifications have met the acceptance criteria" as part of the verification and validation (V&V) activities. However, the specific quantitative acceptance criteria, detailed performance metrics, sample sizes, ground truth establishment, or expert involvement for these V&V activities are not included in this public summary.

Therefore, the requested information cannot be precisely extracted from the provided text.

Summary of Information Available (and Not Available) from the Document:

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AI-Rad Companion Prostate MR is indicated for the processing and annotation of DICOM MR prostate images acquired in adult male populations that demonstrate indications of oncological abnormalities in the prostate.

The AI-Rad Companion Prostate MR software aims to support the radiologist and provides the following functionality:
• Viewing, analyzing, evaluating prostate MR images including DCE, ADC, T2 and DWI
• Hosting application for and provides interface to external Prostate MR AI plug-in device
• Accept/reject/edit the results generated by the plug-in software Prostate MR AI

AI-Rad Companion Prostate MR is a diagnostic aid in the interpretation of prostate MRI examinations acquired according to the PI-RADS standard.

AI-Rad Companion Prostate MR provides quantitative and qualitative information based on bi or multiparametric prostate MR DICOM images. It displays information on the segmented gland, prostate volume, and segmented lesions along with their classifications. This information can be used to support the reading and reporting of prostate MR studies, as well as the planning of prostate biopsies in the case of ultrasound guided MR-US fusion biopsies of the prostate gland.

The primary features of AI-Rad Companion Prostate MR include:
• Display of Automatic Segmentation and volume of the prostate gland as well as display of automatic segmentation, quantification and classification of lesions
• Manual Adjustment of gland and lesion segmentation and editing of lesion scores, diameter, and localization of the automated generated lesions
• Marking of new lesions
• Export of results as RTSS format for import into supporting ultrasound or fusion biopsy planning systems

Based on the provided FDA 510(k) clearance letter for AI-Rad Companion Prostate MR (K252608), there is no specific study described that proves the device meets predefined acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). The document primarily focuses on demonstrating substantial equivalence to a predicate device (AI-Rad Companion Prostate MR K193283) and adherence to non-clinical verification and validation standards for software development and risk management.

The document explicitly states: "No clinical tests were conducted to test the performance and functionality of the modifications introduced within AI-Rad Companion Prostate MR."

Therefore, a table of acceptance criteria and reported device performance, information about sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details are not available in this document as no clinical performance study for the modified device was performed.

The document emphasizes that modifications and improvements were verified and validated through non-clinical tests (software verification and validation, unit, system, and integration tests), which demonstrated conformity to industry standards and the predicate device's existing safety and effectiveness.

Here’s a breakdown of what is stated in the document regarding testing:

1. A table of acceptance criteria and the reported device performance:

• Not provided. The document does not include a table of specific clinical acceptance criteria (e.g., target sensitivity or specificity values) or reported device performance metrics against such criteria. The focus is on demonstrating that software enhancements do not adversely affect safety and effectiveness, assuming the predicate device's performance was already acceptable.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. Since no clinical performance study was conducted for this specific submission, details on test set sample sizes and data provenance are not presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. As no clinical study is reported, this information is not available.

4. Adjudication method (e.g. 2+1, 3+1, none) 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:

• Not done. The document explicitly states "No clinical tests were conducted."

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

• Not explicitly stated for the modified device. While the device description mentions automatic segmentation and classification, the overall context emphasizes a "diagnostic aid" that "aims to support the radiologist" and has functionality to "Accept/reject/edit the results generated by the plug-in software Prostate MR AI." This suggests an interactive workflow where standalone performance is not the primary claim for this particular submission. The separate product, "Prostate MR AI (K241770)," which performs the core AI tasks, is likely where standalone performance would be detailed, but not in this document.

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

• Not applicable for this submission, as no new clinical performance study is detailed for the modified device. The original predicate device's performance would have relied on a ground truth, but that information is not part of this document.

8. The sample size for the training set:

• Not provided. Since this submission is for an updated version of an already cleared device and no new clinical performance study is detailed, the training set size for the underlying AI model (likely part of K241770 or the predicate K193283) is not included here.

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

• Not provided. This information would typically be detailed in the original submission for the AI algorithm (likely K241770 or K193283), not in this update focused on software enhancements and substantial equivalence.

In summary, the provided document focuses on demonstrating that the enhancements and modifications to the AI-Rad Companion Prostate MR do not adversely affect the safety and effectiveness of the existing predicate device. It relies on non-clinical software verification and validation, and substantial equivalence arguments, rather than presenting a de novo clinical performance study with new acceptance criteria and results.

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