Stryker Navigation Enabled Instruments are intended to be used in the preparation and placement of Stryker screws (including XIA 3 (including Serrato), XIA 4.5 (including XIA CT), ES2, Mantis Redux, and XIA 2) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medironic System, which is indicated for anv 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. Stryker Navigation Enabled Screwdrivers are also compatible with the Medtronic IPC POWEREASE System.

Device Description

Navigation Enabled Instruments are nonsterile, reusable instruments, including taps which are operated manually and drivers that can be manually operated or operated with the Medtronic IPC POWEREASE System. These instruments are intended to be used with the Medtronic StealthStation system.

AI/ML Overview

The provided document is a 510(k) Summary for "Navigation Enabled Instruments" from Stryker. It details the device's intended use and claims substantial equivalence to predicate devices but does not include a specific study that proves the device meets detailed acceptance criteria with numerical performance data. The summary mentions "Design validation testing, including registration, and accuracy, was conducted" but does not provide the results of this testing.

Therefore, I cannot provide all the requested information. However, I can extract what is available regarding the performance data and criteria mentioned.

Here's the information that can be extracted from the provided text:

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

The document mentions "Design validation testing, including registration, and accuracy, was conducted" to ensure the instruments are "acceptable for their intended use," functionality, and compatibility. However, specific numerical acceptance criteria (e.g., "Registration accuracy must be within X mm") and reported device performance (e.g., "Registration accuracy was Y mm") are not provided in this 510(k) summary.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

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

The document indicates "Design validation testing" was performed, which likely involved a test set. However, the sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) are not specified.

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

The document makes no mention of experts being used to establish ground truth for testing. The testing described appears to be technical validation (e.g., accuracy, registration) rather than evaluations requiring clinical expert interpretation.

4. Adjudication method for the test set

Not applicable, as no expert evaluation is described.

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

An MRMC study is not mentioned. The device described is "Navigation Enabled Instruments," which are physical tools for surgical navigation, not an AI-assisted diagnostic or interpretive system that would typically be evaluated with MRMC studies for human reader improvement.

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

Not applicable, as this is a physical instrument for surgical navigation, not a standalone algorithm.

7. The type of ground truth used

The document states "Registration testing was performed to ensure that the instruments can be registered to the StealthStation®. Accuracy testing was completed for comparison to the predicate instruments." This implies a ground truth based on measurable physical properties and established benchmarks (e.g., a known precise measurement or a predicate device's performance). The specific method of establishing this precise "ground truth" (e.g., using a highly accurate measurement system, phantom models) is not detailed.

8. The sample size for the training set

This device does not appear to be an AI/ML device in the traditional sense that requires a training set of data. Therefore, a training set sample size is not applicable or not specified.

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

Not applicable, as no training set is described for this type of device.

Summary

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May 17, 2019

Stryker Megan Callanan Regulatory Affairs Associate 2 Pearl Court Allendale, New Jersey 07401

Re: K183381

Trade/Device Name: Navigation Enabled Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 3, 2019 Received: May 6, 2019

Dear Megan Callanan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183381

Device Name Navigation Enabled Instruments

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

510(k) Summary: Navigation Enabled
Submitter:	Stryker Spine2 Pearl CourtAllendale, NJ 07401
Contact Person:	Name: Megan CallananPhone: (201)845-4900Email: megan.callanan1@stryker.com
Date Prepared:	12/04/18
Trade Name:	Navigation Enabled Instruments
Common Name:	Navigation Instruments
Proposed Class:	Class II
Classification Name:	Orthopedic / Orthopedic Stereotaxic Instruments
Regulation Number:	21 CFR 882.4560
Product Code:	OLO
Predicate Devices:	Primary Predicate: Globus Navigation Instruments (K153203)Additional Predicates: Medtronic Navigated Instruments (K143628,K143375, K140454, K180690)
Device Description:	Navigation Enabled Instruments are nonsterile, reusable instruments,including taps which are operated manually and drivers that can be manuallyoperated or operated with the Medtronic IPC POWEREASE System. Theseinstruments are intended to be used with the Medtronic StealthStationsystem.
Indications for use:	Stryker Spine Navigation Enabled Instruments are intended to be used in thepreparation and placement of Stryker screws (including XIA 3 (includingSerrato), XIA 4.5 (including XIA CT), ES2, Mantis, Mantis Redux, and XIA 2)during spinal surgery to assist the surgeon in precisely locating anatomicalstructures in either open or minimally invasive procedures. Theseinstruments are specifically designed for use with the MedtronicStealthStation® System, which is indicated for any medical condition inwhich the use of stereotactic surgery may be appropriate, and wherereference to a rigid anatomical structure, such as a skull, a long bone, orvertebra, can be identified relative to a CT or MR based model, fluoroscopyimages, or digitized landmarks of the anatomy. Stryker Spine NavigationEnabled Screwdrivers are also compatible with the Medtronic IPCPOWEREASE System.
Summary of theTechnologicalCharacteristics	Navigation Enabled Instruments have the same technological characteristicsas the predicate devices including design, material composition, intendeduse, function, and range of sizes. Biocompatibility of patient-contacting
510(k) Summary: Navigation Enabled
	materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.
Summary of thePerformance Data	Design validation testing, including registration, and accuracy, was conducted to ensure the Navigation Enabled Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation® using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instruments. Registration testing was performed to ensure that the instruments can be registered to the StealthStation®.Accuracy testing was completed for comparison to the predicate instruments.
Conclusion	Stryker Spine Navigation Enabled Instruments are substantially equivalent to the noted predicate devices as they have the same intended use, technological characteristics, safety and efficacy profile, and performance specifications.The content of this submission supports the determination of substantial equivalence.

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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).