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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 with new software version SMR VB40A consists of the following enhancements and improvements to extend the different workflows and applications which are currently offered on the predicate device, syngo.MR Applications with SMRVB30A (K180336):

Enhanced functionality within the syngo.MR General application:

• Prostate Biopsy Support
  Renaming and enhanced functionality within the syngo.MR Oncology application:
• syngo.MR OncoCare will be renamed to syngo.MR OncoTrend .
• . ADC-based whole-body diffusion evaluation

The provided document is a 510(k) Premarket Notification for the syngo.MR Applications device (new software version SMR VB40A). This document declares substantial equivalence to a predicate device (syngo.MR Applications SMRVB30A, K180336) and does not contain detailed information about specific acceptance criteria or dedicated studies that "prove" the device meets acceptance criteria in the way a clinical trial would for a novel device.

Instead, the document focuses on verification and validation activities to demonstrate that changes made in the new software version do not introduce new safety or effectiveness concerns compared to the already cleared predicate device.

Here's an analysis based on the information provided and addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for a specific clinical task. This type of detail is generally not included in a 510(k) for a software update that claims substantial equivalence to a predicate device where the core functionality and intended use remain the same.

The "acceptance criteria" here are implicitly linked to the successful completion of software verification and validation, demonstrating that the enhanced functionalities perform as intended and do not negatively impact safety or effectiveness.

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

• Test Set Sample Size: The document does not specify a "test set" in the context of clinical images or patient data to evaluate a specific diagnostic performance metric. The testing conducted was focused on software verification and validation.
• Data Provenance: Not applicable as no clinical test set is described.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document states "No clinical tests were conducted to test the performance and functionality of the modifications." Therefore, no ground truth established by experts is mentioned.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set is described.

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

No MRMC study was conducted or reported. The document explicitly states: "No clinical tests were conducted to test the performance and functionality of the modifications introduced within syngo.MR Applications with software version SMRVB40A."

6. Standalone (Algorithm Only) Performance Study

No standalone performance study of an algorithm is described. The device is a post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing medical images.

7. Type of Ground Truth Used

Not applicable, as no clinical tests requiring ground truth were performed. The "ground truth" for the software verification and validation would be the expected behavior or output of the software functions as defined in its requirements.

8. Sample Size for the Training Set

Not applicable. The document describes a software update with "enhancements and improvements to extend the different workflows and applications." It does not mention any machine learning components that require a "training set" for model development.

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

Not applicable, as no training set is mentioned.

Summary of the Study and Device Performance (within the context of a 510(k) for a software update):

The "study" described in the document is the Software Verification and Validation testing.

• Purpose: To demonstrate that the new software version (SMR VB40A) with its enhancements (Prostate Biopsy Support, renaming/enhancements of syngo.MR OncoCare to syngo.MR OncoTrend, and ADC-based whole-body diffusion evaluation) performs as intended and is as safe and effective as the predicate device (SMRVB30A).
• Acceptance Criteria (Implicit):
  • Successful completion of all software verification and validation tests.
  • Compliance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
  • The modifications do not introduce new issues of safety or effectiveness.
  • The device conforms to various recognized standards (ISO 14971, IEC 62366-1, IEC 62304, NEMA DICOM PS 3.1 - 3.20).
• Reported Device Performance:
  • "Performance Evaluation of the described modifications were completed."
  • "The results from each set of tests demonstrate that the device performs as intended and is therefore substantially equivalent to the predicate device to which it has been compared."
  • "While these enhancements and improvements offer additional image viewing and evaluation capabilities compared to the predicate device, the conclusions from all verification and validation data suggest that these modifications bear an equivalent safety and performance profile to the predicate device."
  • "The enhancements and improvements offer additional possibilities for the image viewing and evaluation. The modifications aim to improve user workflow and reduce the complexity of the imaging procedure and do not change the intended use."

In conclusion, this 510(k) for syngo.MR Applications (SMR VB40A) relies on software verification and validation testing and compliance with regulatory standards to prove that the device meets its acceptance criteria for being substantially equivalent to its predicate. It does not involve de novo clinical studies with patient data, clinical test sets, or expert ground truth adjudication in the typical sense for a new diagnostic claim.

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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.

The syngo.MR Applications are syngo based post-processing software/applications to be used for viewing and evaluating ' MR images provided by a maqnetic resonance diagnostic device and enabling structured evaluation of MR images. syngo.MR Brain Morphometry extends the MR Neurology workflow and offers a comprehensive package for the automatic calculation of the volume properties of different brain structures using MPRAGE datasets, which are typically acquired for a typical MR examination of the head.

With this premarket submission, the new functionality syngo.MR Brain Morphometry is introduced to extend the MR Neurology workflow that is a part of the formerly cleared medical device syngo.MR Applications (K180336).

Here's a breakdown of the acceptance criteria and study information for syngo.MR Brain Morphometry, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that "Acceptance criteria for performance tests were defined based on a literature review. In all validation experiments, syngo.MR Brain Morphometry passed the acceptance criteria." However, it does not explicitly list the specific numerical acceptance criteria. Instead, it provides the reported device performance in terms of correlation coefficients.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: 1200 subjects.
   • Data Provenance: The dataset consisted of Alzheimer's patients (AD), mild cognitive impaired patients (MCI), and healthy controls (HC). The country of origin and whether the data was retrospective or prospective are not specified in the provided text.

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

   • The document primarily describes a validation study comparing the automated results to a "reference." It does not explicitly state that human experts were used to establish a ground truth for the test set in the traditional sense of consensus reading for image interpretation. The "reference" appears to be an established method or device, but details on its nature (e.g., manual segmentation by neuro-radiologists) are not provided.

3. Adjudication Method:

   • Not applicable/Not described. The validation appears to be against a "reference" rather than through an adjudication process among human readers.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not explicitly conducted or described. The study focused on the standalone performance of the algorithm against a reference.

5. Standalone Performance:

   • Yes, a standalone (algorithm only) performance evaluation was conducted. The performance metrics (accuracy, repeatability, reproducibility) were quantified for syngo.MR Brain Morphometry.

6. Type of Ground Truth Used:

   • The accuracy of volumetric results was validated by comparing the automated results to a "reference." The specific nature of this reference (e.g., manual segmentation, results from another validated software, pathology) is not detailed.

7. Sample Size for the Training Set:

   • The sample size for the training set is not provided in the document. The text focuses on the validation of the new feature.

8. How the Ground Truth for the Training Set Was Established:

   • This information is not provided in the document.

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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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