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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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