Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE™ System.

Device Description

The Navigated VERTEX SELECT® Instruments are both non-sterile, reusable and sterile, single use instruments that can be operated manually or under power. These instruments are intended to be used when implanting components of the VERTEX® Reconstruction System. The Navigated VERTEX SELECT® Instruments are also compatible with the StealthStation® and IPC® POWEREASE® Systems.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Navigated VERTEX SELECT® Instruments." This document outlines the device's characteristics, its indications for use, and a summary of performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" with specific numerical thresholds for each test. Instead, it describes the purpose of each test and implies successful completion, indicating the device met the intended functional and compatibility requirements.

Test	Description	Reported Device Performance (Implied)
Navigation Accuracy Analysis	Confirmed navigated instrument accuracy	The test was "completed to ensure the functionality and compatibility." It is implied that the instrument's accuracy, when navigated, was confirmed to be acceptable.
Anatomical Simulated Use	Confirmed instrument functionality under expected use conditions	The test confirmed "instrument functionality under expected use conditions." This suggests the instruments performed as intended in a simulated anatomical environment.
Navigation Simulated Use	Confirmed navigation system functionality under expected use conditions	The test confirmed "navigation system functionality under expected use conditions." This indicates the device's interaction with the navigation system (StealthStation®) was successful.
CAD Model Evaluation	Verified that the CAD models are accurately reflected in the application software	The evaluation "verified that the CAD models are accurately reflected in the application software." This ensures the virtual representation matches the physical design for navigation.
Implant/Instrument Mating	Verified that the instruments can be assembled with the appropriate devices according to their intended use	The test "verified that the instruments can be assembled with the appropriate devices according to their intended use." This confirms proper fit and function with the VERTEX® Reconstruction System screws.
Spine Tools Package Functional Testing	Verified that the Spine Tools package has met the required interface needs of the spine application software	The testing "verified that the Spine Tools package has met the required interface needs of the spine application software." This ensures software compatibility and proper integration within the surgical navigation platform.

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

The document does not specify the sample size used for any of the tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of data). The testing appears to be in-house, pre-market validation conducted by Medtronic.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set. Given the nature of the tests (functional and compatibility), ground truth would likely be established through engineering specifications, design requirements, and direct observation by qualified test personnel.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method for the test set. The tests appear to be pass/fail based on predetermined criteria (e.g., "confirmed accuracy," "verified functionality").

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:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not applicable to this device. The Navigated VERTEX SELECT® Instruments are surgical tools designed for precision during spinal surgery, not an AI-assisted diagnostic or interpretative system for human readers. Therefore, there's no "human reader" component to measure improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The concept of "standalone performance" (algorithm only) is not applicable to this device in the same way it would be for an AI diagnostic tool. The device is a physical instrument intended for use with a navigation system (StealthStation®) controlled by a human surgeon. The "navigation accuracy analysis" and "navigation simulated use" tests assess the performance of the instrument in conjunction with the navigation system, which is a form of integrated performance rather than a standalone algorithm.

7. The Type of Ground Truth Used:

The ground truth for these tests appears to be based on:

Engineering Specifications and Design Requirements: For tests like "Navigation Accuracy Analysis," the ground truth would be the expected or designed level of accuracy for the navigated instruments.
Intended Use Conditions: For "Anatomical Simulated Use" and "Navigation Simulated Use," the ground truth would be the defined functional performance under expected surgical scenarios.
CAD Model Fidelity: For "CAD Model Evaluation," the ground truth is the actual design parameters of the CAD models.
Assembly and Interface Specifications: For "Implant/Instrument Mating Conditions" and "Spine Tools Package Functional Testing," the ground truth is the specified fit, form, and function for mating and interface.

The ground truth is therefore primarily based on predetermined specifications and successful functional operation rather than expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or prognostic devices.

8. The Sample Size for the Training Set:

The document does not mention a "training set" because this device is a physical surgical instrument and not an AI/machine learning model that requires training data.

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

As there is no training set for this device (it's not an AI/ML product), this question is not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of what appears to be a family.

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

Medtronic Sofamor Danek USA, Incorporated Mr. Tejas Patel Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

February 12, 2015

Re: K143628

Trade/Device Name: Navigated VERTEX SELECT® Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: December 19, 2014 Received: December 22, 2014

Dear Mr. Patel:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

Page 2 - Mr. Tejas Patel

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

K143628

510(k) Number (if known)

Device Name

Navigated VERTEX SELECT® Instruments

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

December 19, 2014

I. Company: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 Telephone Number: (901) 396-3133
- Contact: Tejas Patel Regulatory Affairs Specialist Telephone number: (901) 396-3133 Email: tejaskumar.r.patel@medtronic.com
II. Proprietary Trade Name: Navigated VERTEX SELECT® Instruments

Common Name: Stereotaxic Instrument, Navigated Screwdriver, Navigated Tap, Navigated Drill Bit

Classification Name: Stereotaxic Instrument (21 CFR 882.4560)

Classification: Class II

Product Code: OLO

III. Predicate Device:

Navigated CD HORIZON® SOLERA® Screwdrivers and Taps (K140454, S.E. 05/22/2014)

This predicate has not been subject to a design-related recall. This predicate is the primary predicate for this submission.

No reference devices were used in this submission.

IV. Device Description:

V. Indications for Use:

Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely

{4}------------------------------------------------

locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Instruments are also compatible with the IPC® POWEREASE® System.

VI. Comparison of the Technological Characteristics with the Predicate Device:

The Navigated VERTEX SELECT® Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the StealthStation® System. Identical to the predicates, the Navigated VERTEX SELECT® Instruments attach to the NavLock™ Tracker, which allows for optical navigation of the surgical instruments. These devices have similar designs as the predicate devices and incorporate the same design features to enable navigation and use with the IPC® POWEREASE® System, when desired. Like the predicate devices, the subject Navigated VERTEX SELECT® Instruments are also made from stainless steel.

The following technological differences exist between the subject and predicate devices:

. The Navigated VERTEX SELECT® Instruments are intended to be used with VERTEX ® Reconstruction System screws whereas the predicate Navigated CD HORIZON® SOLERA® instruments are intended to be used with the CD HORIZON® SOLERA® screws.
The subject devices include a sterile drill bit while the predicate devices do not.
The subject Navigated Taps & Drill Bits have a single lead threadform as compared to the dual lead threadform of the predicate Navigated Taps.

The instrument modifications detailed in this submission have no impact on the technological characteristics of either the existing instruments or the StealthStation® and IPC® POWEREASE® Systems.

VII. Performance Data:

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:

Test	Description
Navigation AccuracyAnalysis	Confirmed navigated instrument accuracy
Anatomical Simulated Use	Confirmed instrument functionality under expecteduse conditions

{5}------------------------------------------------

Navigation Simulated Use	Confirmed navigation system functionality under expected use conditions
CAD Model Evaluation	Verified that the CAD models are accurately reflected in the application software
Implant/Instrument Mating Conditions	Verified that the instruments can be assembled with the appropriate devices according to their intended use
Spine Tools Package Functional Testing	Verified that the Spine Tools package has met the required interface needs of the spine application software

VIII. Conclusions

The Navigated VERTEX SELECT® Instruments have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).