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 Cobb Elevator. Combo Tool, Curette, Osteotome, and Rotating Shaver are instruments that are manual accessories to the StealthStation System. These instruments can be used to facilitate a discectomy during a spinal surgery procedure. These devices are offered in non-sterile form and are reusable.

The stainless steel material used in the Disc Prep Instruments conforms to ASTM F899, ASTM A693 and ASTM A564 standards.

Implant size and placement is determined by selecting the trial which provides the most satisfactory fit in the prepared disc space. Once trialing is complete, the implant of corresponding size is positioned. The new trials are designed specifically to be used with CAPSTONE and are also compatible with StealthStation. The trials will be provided non-sterile and are reusable.

The stainless steel material used in the CAPSTONE Trials conforms to ASTM F899, ASTM A693 and ASTM A564 standards.

AI/ML Overview

The document describes a 510(k) premarket notification for "Navigated Disc Prep Instruments and CAPSTONE Trials." This submission focuses on medical devices (surgical instruments) and does not involve an AI algorithm with specific performance metrics like sensitivity or specificity. Therefore, many of the requested categories for AI-based device evaluations (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document.

However, I can extract information related to the device's performance testing and acceptance criteria as described for these non-AI instruments.

1. A table of acceptance criteria and the reported device performance

The document provides a table summarizing the performance testing completed, with descriptions of what each test confirmed. It does not explicitly state numerical acceptance criteria in a "criteria vs. result" format, but rather descriptions of what the tests successfully "confirmed" or "verified."

Test Name	Acceptance Criteria (Implied by Description)	Reported Device Performance
Navigation Accuracy Analysis	The navigated instrument's accuracy is confirmed.	Confirmed navigated instrument accuracy.
Anatomical Simulated Use	Instrument functionality is confirmed under expected use conditions.	Confirmed instrument functionality under expected use conditions.
Navigation Simulated Use	Navigation system functionality is confirmed under expected use conditions.	Confirmed navigation system functionality under expected use conditions.
CAD Model Evaluation	CAD models are accurately reflected in the application software.	Verified that the CAD models are accurately reflected in the application software.
Implant/Instrument Mating Conditions	Instruments can be assembled with appropriate devices according to intended use.	Verified that the instruments can be assembled with the appropriate devices according to their intended use.
Spine Tools Package Functional Testing	Spine Tools package meets the required interface needs of the spine application software.	Verified that the Spine Tools package has met the required interface needs of the spine application software.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each test. The testing appears to be internal validation (e.g., in a lab or simulated environment) as opposed to human clinical trials with patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective nature is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The document describes testing of physical surgical instruments and their compatibility with a navigation system, not the performance of an AI algorithm requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. This is not a study involving human readers or interpretation requiring an adjudication method.

5. 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 document is not about an AI-assisted device for human readers.

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

Not applicable. This document is about surgical instruments, not a standalone algorithm.

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

The "ground truth" for the performance testing of these physical instruments would be engineering specifications, design requirements, and a functional physical environment (e.g., anatomical models for simulated use). It's not expert consensus, pathology, or outcomes data in the biological sense. The testing confirmed the instruments met their design and functional objectives.

8. The sample size for the training set

Not applicable. There is no AI algorithm being trained.

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

Not applicable. There is no AI algorithm being trained.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.

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

Medtronic Sofamor Danek USA, Incorporated Mr. Nicholas Tabrizi Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

June 16, 2015

Re: K150231

Trade/Device Name: Navigated Disc Prep Instruments and CAPSTONE Trials Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: May 13, 2015 Received: May 14, 2015

Dear Mr. Tabrizi:

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

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Page 2 - Mr. Nicholas Tabrizi

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

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Indications for Use

510(k) Number (if known) K150231

Device Name

Navigated Disc Prep Instruments and CAPSTONE Trials

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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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:

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510(k) Summary

June 2015

I.	Company:	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, TN 38132Telephone Number: (901) 396-3133
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Contact: Nicholas Tabrizi Principal Regulatory Affairs Specialist Telephone: (901) 344-1463 Fax: (901) 346-9738
II. Proprietary Trade Name: Navigated Disc Prep Instruments and CAPSTONE Trials

Common Name: Stereotaxic Instrument, Navigated Instruments

Classification Name: Stereotaxic Instruments (21 CFR 882.4560)

Classification: Class II

Product Code: OLO

III. Product Description:

The stainless steel material used in the Disc Prep Instruments conforms to ASTM F899, ASTM A693 and ASTM A564 standards.

CAPSTONE Trials

The stainless steel material used in the CAPSTONE Trials conforms to ASTM F899, ASTM A693 and ASTM A564 standards.

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IV. Indications for Use:

V. Identification of Legally Marketing Devices (Predicate Devices)

Navigated CD HORIZON® SOLERA® Instruments (K140454) ● This predicate has not been subject to a design-related recall. This predicate is the primary predicate for this submission.
Navigated CAPSTONE Trials, CLYDESDALE Trials, CAPSTONE & . CLYDESDALE Inserter (K131425) This predicate has not been subject to a design-related recall. This predicate is an additional predicate for this submission.

VI. Comparison of the Technological Characteristics:

The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. 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 as the predicate devices and incorporate the same design features to enable navigation capabilities. Like the predicate devices, the subject Navigated Taps and Screwdrivers 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.

VII. Discussion of the Performance Testing

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

Test	Description
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Test	Description
NavigationAccuracy Analysis	Confirmed navigated instrument accuracy.
AnatomicalSimulated Use	Confirmed instrument functionality under expected use conditions.
NavigationSimulated Use	Confirmed navigation system functionality under expected useconditions.
CAD ModelEvaluation	Verified that the CAD models are accurately reflected in theapplication software.
Implant/InstrumentMating Conditions	Verified that the instruments can be assembled with the appropriatedevices according to their intended use.
Spine ToolsPackageFunctional Testing	Verified that the Spine Tools package has met the required interfaceneeds of the spine application software.

VIII. Conclusions

The Navigated Disc Prep Instruments and CAPSTONE Trials 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).