The Navigated Disc Preparation Instruments are intended to facilitate a discectomy during spinal surgery. The Navigated CAPSTONE™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for ELEVATE™ Spinal System, they are intended to be used to facilitate implant size selection.

The Navigated Probe is intended to be used during pedicle and disc preparation during spinal fusion procedures. The Navigated Inserters are intended to be used for the placement of an implant.

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.

Device Description

The Navigated ELEVATE™ Inserter and navigated rotating shavers are non-sterile, reusable surgical instruments that are intended to be used to facilitate a discectomy and placement of implants during spinal surgery procedure. The subject devices are designed specifically to be used with ELEVATE™ Spinal System and are also compatible with the StealthStation. These devices are offered in non-sterile form and are reusable. This subject devices are manufactured from stainless steel and silicone. The case and trays are manufactured from aluminum with either silicone or nylon coated brackets.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific device performance criteria with clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert ground truth, and MRMC studies is not detailed in this type of submission.

However, I can extract the available information regarding performance data.

Table of Acceptance Criteria and Reported Device Performance

The submission summarizes "Performance Data" through a series of tests to ensure functionality and compatibility. The specific "acceptance criteria" are implied by the nature of these tests (e.g., successful function, accurate navigation, correct mating) rather than quantified metrics with thresholds.

Test	Description	Reported Device Performance (Implied from "Confirmed" and "Verified")
Navigation Accuracy Analysis	Confirmed navigated instrument accuracy in both 2D and 3D space.	Navigation accuracy of the instrument was confirmed in both 2D and 3D space.
Anatomical Simulated Use	Confirmed instrument functionality under expected use conditions.	Instrument functionality was confirmed under expected use conditions.
Navigation Simulated Use	Confirmed navigation system functionality under expected use conditions.	Navigation system functionality was confirmed under expected use conditions.
CAD Model Evaluation	Verified that the CAD models are accurately reflected in the application software.	CAD models were verified to be 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.	Instruments were verified to be assembled with 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.	The Spine Tools package (Version 25, compatible with Synergy Spine 2.1 application on the S7) was verified to meet the required interface needs of the spine application software.

Details Not Available in the Provided Text:

The following information is not present in the provided 510(k) summary, as these types of details typically come from more in-depth study reports which are usually not included in the publicly available summary for a 510(k) submission.

Sample size used for the test set and the data provenance: Not specified. This submission focuses on design and function verification, not clinical data from patients. The tests mentioned appear to be laboratory or bench-top evaluations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. "Ground truth" in the clinical sense (e.g., diagnosis) is not relevant for these engineering verification tests.
Adjudication method for the test set: Not specified.
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: Not applicable. This device is a surgical instrument system, not an AI diagnostic tool, and no MRMC studies are mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a navigated surgical instrument, inherently used with a human in the loop.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance tests listed, the "ground truth" would be engineering specifications, physical measurements, and proper functional operation according to design, not clinical ground truth.
The sample size for the training set: Not applicable. This device does not use machine learning in a way that requires a "training set" in the conventional sense of AI/algorithm development. The "Spine Tools Package" refers to software compatibility and functionality, not an AI model.
How the ground truth for the training set was established: Not applicable.

Summary

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

April 14, 2017

Medtronic Sofamor Danek USA, Inc Laveeda Leflore Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

Re: K163581

Trade/Device Name: Navigated Elevate Inserter and Navigated Disc Prep Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 19, 2016 Received: December 20, 2016

Dear Laveeda Leflore:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

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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/ResourcesforYou/Industry/default.htm. 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 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,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K163581

Device Name

Navigated ELEVATE™ Inserter and Navigated Disc Prep Instruments.

Indications for Use (Describe)

The Navigated Probe is intended to be used during pedicle and disc preparation during spinal fusion procedures. The Navigated Inserters are intended to be used for the placement of an implant.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/14)

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510(k) Summarv December 19, 2016

l. Company: Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis. TN 38132 Telephone: (901) 396-3133
- Laveeda Leflore Contact: Regulatory Affairs Specialist Telephone: (901) 396-3133 Email: Laveeda.r.leflore@medtronic.com
II. Proprietary Trade Name: Navigated ELEVATE™ Inserter and Navigated Disc Prep Instruments.

Common Name: Stereotaxic Instrument, Navigated Instruments

Classification Name: Stereotaxic Instrument (21 CFR 882.4560)

Classification: Class II

Product Code: OLO

III. Predicate Device:

Navigated Disc Prep Instruments (K150231, S.E. 06/16/2015) primary predicate ●
. Navigated Interbody Trials and Inserter (K131425, S.E. 08/14/2013) - secondary predicate
ELEVATE™ Spinal System (K142559, S.E. 06/09/2015) - secondary predicate

The predicate devices have not been subject to a design-related recall.

IV. Product Description:

V. Indications for Use:

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The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy during spinal surgery. The Navigated CAPSTONE™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for ELEVATE™ Spinal System, they are intended to facilitate implant size selection.

The Navigated Probe is intended to be used during pedicle and disc preparation during spinal fusion procedures. The Navigated Inserters are intended to be used for the placement of an implant.

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

The subject Navigated ELEVATE™ Inserter is intended to be used for the placement of implants. The subject navigated rotating shavers will have a dual indication. They can be used as shavers to facilitate a discectomy or as trials to facilitate implant size (height) selection of the ELEVATE™ Spinal System implants during a spinal surgery procedure. These instruments are specifically designed for use with the StealthStation® System , which allows for optical navigation of the surgical instruments. These devices have similar designs and uses to the predicate devices and incorporate the same design features to enable navigation capabilities. Like the predicate devices, the subject Navigated ELEVATE™ Inserter and navigated rotating shavers are also made from stainless steel.

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

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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
NavigationAccuracy Analysis	Confirmed navigated instrument accuracy in both 2D and 3D space.
AnatomicalSimulated Use	Confirmed instrument functionality under expected use conditions.
NavigationSimulated Use	Confirmed navigation system functionality under expected use conditions.
CAD ModelEvaluation	Verified that the CAD models are accurately reflected in the application software.
Implant/InstrumentMating Conditions	Verified that the instruments can be assembled with the appropriate devices according to their intended use.
Spine ToolsPackageFunctional Testing	Verified that the Spine Tools package has met the required interface needs of the spine application software.

Table 5-1: Description of Performance Testing

The Navigated ELEVATE™ Inserter and the rotating shavers will use Tools Package Version 25, which will be compatible with the Synergy Spine 2.1 application on the S7.

VIII. Conclusions

That Navigated ELEVATE™ Inserter and the navigated rotating shavers 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).