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The NERVEVISION SOFTWARE SYSTEMS is a stand-alone software application to assist clinicians in segmenting and visualizing nerve anatomy from magnetic resonance images.

The NERVEVISION SOFTWARE SYSTEMS is a software application that has been designed and developed to assist clinicians (radiologists, neurologists, medical physicists, and surgeons) in viewing magnetic resonance images. The software is capable of showing the tissue in individual images from standard Magnetic Resonance (MR) studies for axial, sagittal, or coronal views. The segmented analyses and 3D views of the anatomy can also be viewed.

The NERVEVISION SOFTWARE SYSTEMS provides clinicians with tools to efficiently contour or delineate nerve anatomy in volume data. The results can be saved in digital imaging and communications in medicine (DICOM) and bitmap image file (BMP) formats. The clinician has the ability to save the masked, marked images directly or import them to other software. NERVEVISION SOFTWARE SYSTEMS offers features including:

• . Import and export of DICOM images,
• . Saving outlines and contours in DICOM or BMP format,
• . Semi-automated segmentation,
• . Volume segmentation, visualization, and measurement,
• Edge enhancement (contour enhancement by user controlled edge snapping), .
• Standard functionalities for image visualization (adjusting contrast & brightness, . zoom, and panning)
• . Advanced functions of contour editing for manual segmentation (drawing, outlining, inflating, deflating, shifting, cutting and adding to images), and
• . User access to modify the segmentation results at any time.

The clinician retains the ultimate responsibility for making the diagnosis and patient management decisions based on the standard practices, and comparisons to individual images. The NERVEVISION SOFTWARE SYSTEMS is a set of software tools to complement manual (individual image) nerve viewing techniques.

The NERVEVISION SOFTWARE SYSTEMS does not create original input images of nerves, nor does it change the final results obtained once approved and saved by the clinical expert. As such, this software is considered to have a moderate level of concern.

Here's a breakdown of the acceptance criteria and study information for the NERVEVISION SOFTWARE SYSTEMS, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance Table:

It's important to note that the provided document does not specify quantitative acceptance criteria or provide detailed performance metrics for the NERVEVISION SOFTWARE SYSTEMS itself. The summary focuses on demonstrating substantial equivalence to a predicate device and adherence to general medical imaging standards, rather than direct performance validation against specific clinical thresholds.

Study Information:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. The document explicitly states: "No clinical tests were performed in the development of the NERVEVISION SOFTWARE SYSTEMS." The "bench testing" was conducted to confirm that software requirements were achieved and validated, implying internal verification against specifications, not a test set of patient data.
   • Data Provenance: Not applicable. Given that no clinical tests were performed, there is no patient data or specific provenance information mentioned.

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

   • Not applicable. As no clinical tests were performed, there was no test set requiring expert-established ground truth.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No clinical tests were performed, so no adjudication method was used for a test set.

4. 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. The document explicitly states: "No clinical tests were performed in the development of the NERVEVISION SOFTWARE SYSTEMS." Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

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

   • No. While the device is a "stand-alone software application," the context of its development and intended use as an assistive tool for clinicians, coupled with the explicit statement that "No clinical tests were performed," indicates that no standalone performance study (i.e., algorithm-only performance against a ground truth) was undertaken and reported in this summary. The "bench testing" mentioned focuses on software requirements and validation, not clinical performance. The device is designed to "assist clinicians in segmenting and visualizing nerve anatomy" and the "clinician retains the ultimate responsibility for making the diagnosis and patient management decisions."

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

   • Not applicable. Since no clinical performance studies were conducted, no ground truth based on expert consensus, pathology, or outcomes data was established or used for such a purpose. The "bench testing" would have involved internal validation checks against predefined software specifications.

7. The sample size for the training set:

   • Not reported. The document does not provide any information regarding a training set or its size. This is likely because the device, as described, appears to be a tool for manual or semi-automated segmentation and visualization, rather than a fully automated AI model requiring extensive data for learning. Its features include "Semi-automated segmentation" and various "Advanced functions of contour editing for manual segmentation."

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

   • Not applicable / Not reported. As no training set is mentioned, the method for establishing its ground truth is also not provided.

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