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

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Software Conformance	IEC/ISO 10918-1:1994 Technical Corrigendum 1:2005 (Digital compression and coding)	The NERVEVISION SOFTWARE SYSTEMS conforms to this standard.
Software Conformance	NEMA PS 3.1 - 3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set	The NERVEVISION SOFTWARE SYSTEMS conforms to this standard.
Safety and Effectiveness	Support the safety and effectiveness of use in imaging and examining nerve anatomy.	The submission claims that the performance data provided (conformance to standards, bench testing) supports safety and effectiveness. No specific quantitative performance metrics are provided to demonstrate this claim.
Biocompatibility	Not evaluated for biocompatibility.	No part of this software device is used for patient contact, therefore, biocompatibility evaluation was not required.

Study Information:

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.
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.
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.
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.
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."
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.
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."
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.

Summary

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JUL 2 6 2012

510(k) Summary

per 21CFR807.92

CONTACT: Dr. Lionel Lenkinski 3D Imaging Partners Inc. 5 Hazelton Ave. Suite 300 Toronto, Ontario, Canada Phone: (416) 371-2290 Fax: (416) 972-6208 E-mail: info@nervevision.com Web: http://www.nervevision.com

DATE PREPARED: June 14, 2012

TRADE OR PROPRIETARY NAME: NERVEVISION SOFTWARE SYSTEMS

CLASSIFICATION NAME: System, Image Processing, Radiological

PREDICATE DEVICE: K111311, Segasist Prostate Auto-Contouring Software

DEVICE DESCRIPTION: 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.

. 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

Premarket Notification · 3D Imaging Partners Inc. Page 18 of 67 Additional Information & Revisions for K121075: NERVEVISION SOFTWARE SYSTEMS June 23, 2012

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images. The NERVEVISION SOFTWARE SYSTEMS is a set of software tools to complement manual (individual image) nerve viewing techniques.

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

TECHNOLOGICAL CHARACTERISTICS: The NERVEVISION SOFTWARE SYSTEMS is a stand-alone software application to be used on personal computers running Windows® operating systems. The software is used to visualize and analyze Magnetic Resonance (MR) images of nerves. The NERVEVISION SOFTWARE SYSTEMS provides visualization of the nerves in both two-dimensions (2D) and three dimensions (3D).

Such PACS devices are considered to be of moderate level of concern to the FDA.

COMPARISONS TO PREDICATE: We believe the NERVEVISION SOFTWARE SYSTEMS is substantially equivalent to the Segasist Prostate Auto-Contouring Software (K111311), which also is a software package for analyzing anatomy from medical images. Both the NERVEVISION SOFTWARE SYSTEMS and the predicate Segasist Software are image analysis tools for anatomy.

The predicate Segasist software can be used with Computed Tomography (CT) and ultrasound images in addition to Magnetic Resonance (MR) images. The NERVEVISION SOFTWARE SYSTEMS are only suited to MR images.

The predicate Segasist software is designed for prostate gland anatomy and the NERVEVISION SOFTWARE SYSTEMS is designed for use with nerve anatomy.

The predicate Segasist software does not perform segmentation of nerves or 3D reconstructions of anatomy, unlike the NERVEVISION SOFTWARE SYSTEMS.

SUBSTANTIAL EQUIVALENCE TESTING: Bench testing was performed to ensure that the software requirements were achieved and validated. The NERVEVISION SOFTWARE SYSTEMS conform to these FDA recognized standards for medical images:

IEC/ISO 10918-1:1994 Technical Corrigendum 1:2005 Information technology --. Digital compression and coding, and
NEMA PS 3.1 3.18 (2009) Digital Imaging and Communications in Medicine . (DICOM) Set.

No clinical tests were performed in the development of the NERVEVISION SOFTWARE SYSTEMS.

3D Imaging Partners Inc. Page 19 of 67 Premarket Notification Additional Information & Revisions for K121075: NERVEVISION SOFTWARE SYSTEMS June 23, 2012

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The NERVEVISION SOFTWARE SYSTEMS was not evaluated for biocompatibility because no part of this software device is used for patient contact.

We believe that the performance data provided herein support the safety and effectiveness of use of NERVEVISION SOFTWARE SYSTEMS in imaging and examining nerve anatomy.

Premarket Notification 3D Imaging Partners Inc. Page 20 of 67 Additional Information & Revisions for K121075: NERVEVISION SOFTWARE SYSTEMS June 23, 2012

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002

JUL 26 2012

3D Imaging Partners Inc. % Ms. Carolyn Primus Consultant Primus Consulting 7046 Owl's Nest Terrace BRADENTON FL 34203

Re: K121075

Trade/Device Name: NERVEVISION Software Systems Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 23, 2012 Received: June 28, 2012

Dear Ms. Primus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 a 'CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of -

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as bet form in the quality as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication. - The For in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K121075

Device Name: NERVEVISION SOFTWARE SYSTEMS

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

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Premarket Notification
3D Imaging Partners Inc.
Page 16 of 67
Additional Information & Revisions for K121075: NERVEVISION SOFTWARE SYSTEMS
June 23, 2012

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).