The Navigated Inserter is intended to be use during implant placement of Medtronic intervertebral body fusion devices 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. The 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 Trials and Inserter are non-sterile, reusable surgical instruments intended to be used to facilitate implant sizing and placement of Medtronic intervertebral body fusion devices, respectively, during spinal surgery and are specifically designed for use with the StealthStation® System. These navigated interbody devices are used in conjunction with system Trackers, which allows for optical navigation of the surgical instrument, and are also designed for use with the Medtronic CAPSTONE® and CLYDESDALE® Spinal Systems.

AI/ML Overview

The acceptance criteria and the study proving the device meets them are detailed below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Test Criteria Category	Specific Test	Description of Acceptance Criteria (Implied)	Reported Device Performance
Functionality & Compatibility	Accuracy	The navigated instruments should demonstrate acceptable accuracy in both 2D and 3D space.	"Tested navigated instruments accuracy in both 2D and 3D space." (Implies successful demonstration of accuracy to meet predefined internal standards, though the specific quantitative criteria are not elaborated in this summary).
	Environmental, Life, and Shipping	The navigated instruments should maintain functionality after multiple reprocessing cycles, environmental exposure, and shipping conditions.	"Tested navigated instrument functionality after multiple reprocessing cycles (cleaning and sterilization), simulating environmental exposure under expected use conditions and shipping." (Implies successful functionality post-stress tests, meeting internal performance requirements).
	Simulated Use	The navigated instruments should perform according to user needs and intended use in a simulated environment.	"Tested navigated instruments according to the user's needs and intended use." (Implies successful performance in simulated surgical scenarios, aligning with user requirements and intended function).
	CAD Model	The CAD models of the devices must be accurately reflected in the application software.	"Verified that the CAD models are accurately reflected in the application software." (Indicates successful verification of accurate digital representation).
	Cleaning Verification	The product must be effectively cleanable using both automated and manual methods.	"Verified that the product can be effectively cleaned using automated and manual methods." (Confirms that the cleaning protocols are effective in rendering the devices clean for reuse).
	Implant/Instrument Mating	The instruments must attach and mate correctly with appropriate implant/instrument devices.	"Verified that the instruments can be attached and mated with the appropriate instrument and/or implant devices according to their intended use." (Ensures proper fit and function with associated Medtronic products).
	Spine Tools (Toolcards)	The Spine Tools package must meet 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." (Confirms software compatibility and proper integration within the StealthStation® System for spinal applications).
Substantial Equivalence	Overall Comparison (Indications, Intended Use, Tech Characteristics)	The device must be demonstrated to be substantially equivalent to identified predicate devices in terms of indications for use, intended use, operating principle, and materials.	The document explicitly states: "The subject devices have the same intended use and technological characteristics as the predicate devices." and "The Navigated Trials and Inserter have been shown through comparison and testing to be substantially equivalent to the identified predicate devices." This is the primary conclusion of the 510(k) submission, confirming all comparisons met the substantial equivalence standard.

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

The document does not explicitly state the specific "sample size" for the test set in terms of a number of cases, patients, or specific number of tests conducted for each category. Instead, it lists various tests performed on the device itself. The provenance of the data is internal testing by Medtronic Navigation, Inc. The document does not specify country of origin for the data (beyond the company being based in Louisville, Colorado, USA) or whether it was retrospective or prospective, but given the nature of premarket notification testing, it would generally be considered prospective internal validation testing.

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

The document does not specify the number or qualifications of experts used to establish a "ground truth" for the test set. Given that the listed tests are primarily about physical and software functionality, accuracy, and compatibility, the "ground truth" would likely be established through engineering specifications, technical standards, and internal quality control protocols rather than expert clinical judgment in the traditional sense of medical image interpretation.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The tests appear to be direct measurements, validations, and verifications against predefined specifications and performance metrics, rather than subjective assessments requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No Multi Reader Multi Case (MRMC) comparative effectiveness study is mentioned. The device is a navigated surgical instrument, not an AI diagnostic tool primarily evaluated by human readers for diagnostic accuracy. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not directly applicable in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study for an algorithm without human-in-the-loop performance is described. The device is a surgical instrument that assists a human surgeon through navigation, implying it is inherently "human-in-the-loop." It is not an autonomous algorithm.

7. Type of Ground Truth Used

The ground truth used for the tests appears to be based on:

Engineering Specifications: For accuracy, functionality, and compatibility tests.
Technical Standards: For environmental, life, and cleaning verification tests.
User Requirements/Intended Use: For simulated use and implant/instrument mating.
Internal Quality Control Protocols: General framework for all testing.

There is no mention of ground truth based on expert consensus, pathology, or outcomes data in the context of the device's performance testing for this 510(k) submission.

8. Sample Size for the Training Set

The concept of a "training set" is usually applicable to machine learning or AI models. Since this submission is for navigated surgical instruments, not an AI algorithm requiring training, there is no mention of a training set or its sample size.

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

As there is no mention of a training set (see point 8), there is no information on how its ground truth was established.

Summary

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510(k) Summary

K131425 Page 1 of 5

May 2013

I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200 Fax Number: 720-890-3500
AUG 1 4 2013
Regina Holmes Contact: Sr. Regulatory Affairs Specialist Telephone: (901) 396-3133 Fax: (901) 346-9738
Proprietary Trade Name: Navigated CAPSTONE® Trials, CLYDESDALE® II. Trials, and CAPSTONE® & CLYDESDALE® Inserter
Common Name: Stereotaxic Instrument, Implant Trial, Implant Inserter III.
Classification Name: Stereotaxic Instrument (21 CFR 882.4560) IV.
ﺮ ﺍ V. Classification: Class II
VI. Product Code: OLO, MAX

VII. Product Description:

VIII. Indications for Use:

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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.

Identification of Legally Marketing Devices (Predicate Devices) IX.

NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC . TAPS, LEGACY TAPS (K124004)
CAPSTONE® SPINAL SYSTEM (K073291, K103731) .
CLYDESDALE® SPINAL SYSTEM (K083026, K112405) .

Item	Subject Devices	Predicate Devices
Indications for Use	The Navigated Inserter is intended to be usedduring implant placement of Medtronicintervertebral body fusion devices during spinalsurgery.The Navigated Trials are intended to be used tofacilitate implant size selection of Medtronicintervertebral body fusion devices during spinalsurgery.The navigated instruments are specificallydesigned for use with the StealthStation®System, which is indicated for any medicalcondition in which the use of stereotacticsurgery may be appropriate, and wherereference to a rigid anatomical structure, suchas a skull, a long bone, or vertebra, can beidentified relative to a CT or MR based model,fluoroscopy images, or digitized landmarks ofthe anatomy.	Navigated CD HORIZON® SOLERA™Screwdrivers, CD HORIZON®SOLERA™ Taps, CD HORIZON®SOLERA™ Iliac Taps and CDHORIZON® LEGACY™ Taps -K124004The Navigated Taps and Screwdrivers areintended to be used during the preparationand placement of Medtronic screwsduring spinal surgery and are specificallydesigned for use with the StealthStation®System, which is indicated for anymedical condition in which the use ofstereotactic surgery may be appropriate,and where reference to a rigid anatomicalstructure, such as the skull, a long bone,or vertebra, can be identified relative to aCT or MR based model, fluoroscopyimages, or digitized landmarks of theanatomy.
Item	Subject Devices	Predicate Devices
Intended Use	The Navigated Inserter is intended to be usedduring implant placement of Medtronicintervertebral body fusion devices during spinalsurgery.The Navigated Trials are intended to be used tofacilitate implant size selection of Medtronicintervertebral body fusion devices during spinalsurgery.The navigated instruments are specificallydesigned for use with the StealthStation®System.	CAPSTONE® Spinal System -K073291, K103731The trials and inserter are intended to beused during sizing and placement of theCAPSTONE implant devices,respectively.CLYDESDALE® Spinal System -K083026, K112405The trials and inserter are intended to beused during sizing and placement of theCLYDESDALE implant devices,respectively.
		Navigated CD HORIZON® SOLERATMScrewdrivers, CD HORIZON®SOLERA™ Taps, CD HORIZON®SOLERA™ Iliac Taps and CDHORIZON® LEGACY™ Taps -K124004The Navigated Taps and Screwdrivers areintended to be used during the preparationand placement of Medtronic screwsduring spinal surgery and are specificallydesigned for use with the StealthStation®System.
Operating Principle(Tracking Method)	Identical	Navigated CD HORIZON® SOLERATMScrewdrivers, CD HORIZON®SOLERA™ Taps, CD HORIZON®SOLERA™ Iliac Taps and CDHORIZON® LEGACY™ Taps -K124004Optical (infra-red)
Materials - Trials	Identical	Navigated CD HORIZON® SOLERATMScrewdrivers, CD HORIZON®SOLERA™ Taps, CD HORIZON®SOLERA™ Iliac Taps and CDHORIZON® LEGACY™ Taps -K124004CAPSTONE® Spinal System -K073291CLYDESDALE® Spinal System -K083026

Comparison of the Technological Characteristics: X

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K131425
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K131425

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Item	Subject Devices	Predicate Devices
Materials -Inserter	Identical	CAPSTONE® Spinal System -K10373117-4SS, 465 SS, SiliconCLYDESDALE® Spinal System -K11240517-4 SS, Silicon
Materials - InserterTracker	Identical	Navigated CD HORIZON® SOLERATMScrewdrivers, CD HORIZON®SOLERA™ Taps, CD HORIZON®SOLERA™ Iliac Taps and CDHORIZON® LEGACY™ Taps -K124004Tracker: 6061 Aluminum, 303 SS
SterilizationMethod	Identical	Navigated CD HORIZON® SOLERATMScrewdrivers, CD HORIZON®SOLERA™ Taps, CD HORIZON®SOLERA™ Iliac Taps and CDHORIZON® LEGACY™ Taps -K124004CAPSTONE® Spinal System -K073291, K103731CLYDESDALE® Spinal System -K083026, K112405Method: Steam Sterilization

The subject devices have the same intended use and technological characteristics as the predicate devices.

Discussion of the Performance Testing XI.

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

Test	Description
Accuracy	Tested navigated instruments accuracy in both 2D and 3D space.
Environmental,Life, and Shipping	Tested navigated instrument functionality after multiplereprocessing cycles (cleaning and sterilization), simulatingenvironmental exposure under expected use conditions andshipping.
Simulated Use	Tested navigated instruments according to the user's needs andintended use.

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K131425

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Test	Description
CAD Model	Verified that the CAD models are accurately reflected in theapplication software.
CleaningVerification	Verified that the product can be effectively cleaned usingautomated and manual methods.
Implant/InstrumentMating	Verified that the instruments can be attached and mated with theappropriate instrument and/or implant devices according to theirintended use.
Spine Tools(Toolcards)	Verified that the Spine Tools package has met the required interfaceneeds of the spine application software.

XII. Conclusions

The Navigated Trials and Inserter have been shown through comparison and testing to be substantially equivalent to the identified predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure, positioned to the right. Encircling the symbol are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 14, 2013

Regina Holmes Schior Regulatory Affairs Specialist Medtronic Navigation, Incorporated 826 Coal Creek Circle Louisville, Colorado 80027 USA

Re: K131425

Trade/Device Name: Navigated CAPSTONE® Trials, CLYDESDALE® Trials, and CAPSTONE®& CLYDESDALE™ Inserter Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Codc: OLO, MAX Dated: June 3, 2013 Received: June 5, 2013

Dear Ms. Holmes:

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 11 (Special Controls) or class 111 (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 - Regina Holmes

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fdagov/MedicalDevices/ResourcesforYou/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 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

FOR Peter D. Rumm -S

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

Enclosure

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510(k) Number (if known):

Device Name: Navigated CAPSTONE® Trials, CLYDESDALE® Trials, and CAPSTONE® & CLYDESDALE® Inserter

Indications for Use:

The Navigated Inserter is intended to be use during implant placement of Medironic intervertebral body fusion devices 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.

The 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (2) CFR Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

DSD—DIVISION SIGN-OFF	Joshua C. Nipper
Division of Surgical Devices	-S
510(k) Number:	K131425

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).