importing digital diagnostic and functional imaging datasets (e.g. . MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, US )
. reviewing and analyzing the data in various 2D and 3D presentation formats.
. performing image fusion (co-registration) of datasets,
. segmenting structures in the images with manual and automatic tools and converting them into 3D objects for display,
. exporting results to other Medtronic Navigation planning applications, to a PACS or to Medtronic Navigation surgical navigation systems such as the StealthStation System.

The StealthDTI Package is a subset of StealthViz that implements a special case of segmenting 3D structures from the datasets. It is indicated for use in the processing of diffusion-weighted MRI sequences into 3D objects that represent white-matter tracts.

Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.

Device Description

StealthViz is a general purpose 2D/3D surgical planning and image review and analysis software application running on a standard computer. It enables:

importing digital diagnostic and functional imaging datasets (e.g. MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, US) across a LAN, the internet or a modem, or via local transfer from physical media (e.g. CD, DVD, USB drive),
reviewing and analyzing the data (e.g. making measurements) in various 2D and 3D presentation formats,
performing image fusion (co-registration) of datasets using automated or a manual image-matching technique,
segmenting structures in the images with manual and automatic tools and converting them into 3D objects for display,
creating hybrid datasets by filling in segmented regions slice-by-slice on anatomical datasets, and
exporting results to other Medtronic Navigation planning applications, to a PACS or to other Medtronic Navigation surgical navigation systems such as the StealthStation System.

The StealthDTI Package provides the following additional capabilities:

import diffusion-weighted sequence datasets (gradients),
co-register the gradients with anatomical studies using an automatic algorithm or a manual technique,
perform diffusion tensor calculations to create intermediate datasets such as Fractional Anisotropy and Apparent Diffusion Coefficient and the ability to display these results with, for example, Directionally Encoded Color or grayscale mapping,
enable the user to define regions-of-interest (ROI) from which to . perform white matter tractography (WMT, also known as fiber tracking). The user can define multiple ROIs or use previously segmented objects as ROIs (e.g. an fMRI activation area that has been segmented into a 3D object).
calculated fiber tracts can be displayed and converted into 3D . objects,
all results can be exported as noted for the base StealthViz . application description.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Medtronic Navigation, Inc.'s StealthViz Advanced Planning Application with StealthDTI Package. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a study that proves the device meets those criteria.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Test Testing was performed in two phases. Testing was performed by Visage Imaging, the third party developer, to ensure that all Requirements were met by the product." However, the specific "Requirements" (acceptance criteria) and their corresponding reported device performance values are not detailed in this summary.

2. Sample size used for the test set and the data provenance:

The document mentions "a subset of testing was also performed in-house," but does not specify the sample size used for the test set or the provenance (country of origin, retrospective/prospective) of the data.

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

This information is not available in the provided text.

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

This information is not available in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

This document describes a 2008 submission. The StealthViz Advanced Planning Application with StealthDTI Package is a tool to process and visualize diffusion-weighted MRI sequences into 3D objects representing white-matter tracts for surgical planning and image review/analysis. It is not an AI diagnostic tool and does not involve human readers interpreting results with or without AI assistance in the way modern AI devices do. Therefore, a MRMC comparative effectiveness study in that context would not be applicable to this device. The document does not mention such a study.

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

The document states, "Testing was performed by Visage Imaging, the third party developer, to ensure that all Requirements were met by the product. This testing is referenced in the Trace Matrix which ensures that all requirements were successfully verified." This implies standalone testing of the software's functionality. However, specific details about the "standalone" performance metrics (e.g., accuracy, precision of fiber tracking) are not provided.

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

This information is not available in the provided text. Given the nature of white-matter tractography, "ground truth" would likely involve anatomical atlases, direct anatomical correlation, or expert neuroanatomical review, but this is not stated.

8. The sample size for the training set:

Medtronic Navigation, Inc.'s StealthViz Advanced Planning Application with StealthDTI Package, as described in this 2008 510(k) summary, is a software tool for image processing, co-registration, segmentation, and visualization, particularly for diffusion tensor imaging (DTI). It uses algorithms to perform these functions (e.g., automatic co-registration, diffusion tensor calculations, white matter tractography based on user-defined ROIs).

While such algorithms are developed, they are not typically "trained" in the machine learning sense with a large "training set" of patient data as modern AI/ML devices are. The algorithms are based on established image processing and mathematical principles (e.g., for DTI calculations). Therefore, the concept of a "training set sample size" as relevant to AI/ML is not applicable to this type of device as described in this document.

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

As mentioned above, the concept of a "training set" in the context of modern AI/ML is not directly applicable to this device. Therefore, how ground truth for such a set was established is not discussed in the document.

In summary, while the document confirms testing was performed to verify requirements for the StealthDTI package, it lacks the detailed quantitative information on acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment that would typically be found in a comprehensive study report for a modern AI/ML medical device. The context is a 2008 510(k) summary for a software planning tool, not an AI diagnostic algorithm.

Summary

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K081512

510(k) Premarket Notification for Medtronic Navigation, Inc.'s StealthViz Advanced Planning Application with StealthDTI Package

510k Summary

JUL 1 8 2008

May 16, 2008

Subject:	510(k) Summary of Safety and Effectiveness Information for the StealthViz Advanced Planning Application with StealthDTI Package
Submitter:	John AdamsRegulatory Affairs ManagerMedtronic Navigation, Inc.826 Coal Creek CircleLouisville, CO 80027
Proprietary Name:	StealthViz Advanced Planning Application with StealthDTI Package
Common Name and Classification:	Picture Archival and Communications System
Device Description:	StealthViz is a general purpose 2D/3D surgical planning and image review and analysis software application running on a standard computer. It enables:
	importing digital diagnostic and functional imaging datasets (e.g. MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, US) across a LAN, the internet or a modem, or via local transfer from physical media (e.g. CD, DVD, USB drive),reviewing and analyzing the data (e.g. making measurements) in various 2D and 3D presentation formats,performing image fusion (co-registration) of datasets using automated or a manual image-matching technique,segmenting structures in the images with manual and automatic tools and converting them into 3D objects for display,creating hybrid datasets by filling in segmented regions slice-by-slice on anatomical datasets, andexporting results to other Medtronic Navigation planning applications, to a PACS or to other Medtronic Navigation surgical navigation systems such as the StealthStation System.
	The StealthDTI Package provides the following additional capabilities:
	import diffusion-weighted sequence datasets (gradients),co-register the gradients with anatomical studies using an automatic

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510(k) Premarket Notification for Medtronic Navigation, Inc.'s Stealth Viz Advanced Planning Application with StealthDTI Package

510k Summary

algorithm or a manual technique,

perform diffusion tensor calculations to create intermediate datasets such as Fractional Anisotropy and Apparent Diffusion Coefficient and the ability to display these results with, for example, Directionally Encoded Color or grayscale mapping,
enable the user to define regions-of-interest (ROI) from which to . perform white matter tractography (WMT, also known as fiber tracking). The user can define multiple ROIs or use previously segmented objects as ROIs (e.g. an fMRI activation area that has been segmented into a 3D object).
calculated fiber tracts can be displayed and converted into 3D . objects,
all results can be exported as noted for the base StealthViz . application description.

StealthViz is a software application indicated for use in 2D/3D surgical Intended Use: planning and image review and analysis. It enables:

importing digital diagnostic and functional imaging datasets (e.g. . MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, US )
. reviewing and analyzing the data in various 2D and 3D presentation formats.
. performing image fusion (co-registration) of datasets,
. segmenting structures in the images with manual and automatic tools and converting them into 3D objects for display,
. exporting results to other Medtronic Navigation planning applications, to a PACS or to Medtronic Navigation surgical navigation systems such as the StealthStation System.

{2}------------------------------------------------

510(k) Premarket Notification for Medtronic Navigation, Inc.'s StealthViz Advanced Planning Application with StealthDTI Package

510k Summary

Test Testing was performed in two phases. Testing was performed by Visage Discussion: Imaging, the third party developer, to ensure that all Requirements were met by the product. This testing is referenced in the Trace Matrix which ensures that all requirements were successfully verified.

A subset of testing was also performed in-house to verify compatibility with the Stealth application. This is represented in Product Design Verification and Validation Testing protocols/reports.

Test Conclusion:

Results of the testing performed by Visage Imaging, as well as in-house testing, demonstrate that the StealthDTI package is as safe, as effective, and performs as well as or better than the legally marketed device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines representing the branches of government. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Navigation, Inc. % Mr. Kevin Morningstar Senior Consultant Morningstar Consulting Group LLC 3025 Perry Street DENVER CO 80212

JUL 1 8 2008

Re: K081512

Trade/Device Name: Stealth Viz Advanced Planning Application with StealthDTT Package Regulation Number: 21 CFR 892.2050

Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 16, 2008 Received: May 30, 2008

Dear Mr. Morningstar:

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 vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincercly yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification for Medtronic Navigation, Inc. 's StealthViz Advanced Planning Application with StealthDTI Package

Indications for Use

510(k) Number (if known):

Device Name:

StealthViz Advanced Planning Application with StealthDTI Package

Intended Use: Indications for Use:

Stealth Viz is a software application indicated for use in 2D/3D surgical planning and image review and analysis. It enables:

importing digital diagnostic and functional imaging datasets (e.g. . MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, ग्राद है
reviewing and analyzing the data in various 2D and 3D presentation � · formats,
송 performing image fusion (co-registration) of datasets,
segmenting structures in the images with manual and automatic tools ● and converting them into 3D objects for display,
exporting results to other Medtronic Navigation planning . applications, to a PACS or to Medtronic Navigation surgical navigation systems such as the StealthStation System.

Only DICOM for presentation images can be used on an FDA annroved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.

Prescription Use	X
(Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE).

Arzu M. Whay

Division of Reproductive, Abdominal 10(k) Number

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).