Stryker Navigated Manual Surgical Instruments are intended to be used as accessories to the Stryker Spine Navigation System, when used with the SpineMap 3D Navigation software. They are manual surgical instruments intended to be used in spine surgery to facilitate placement of Stryker Spine implants.

Stryker Navigated Spine Instruments may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

Stryker Navigated Spine Instruments are intended for exclusive use with the Rotational Adaptor and associated Trackers to facilitate the placement of the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, and ES2® Spinal Fixation Systems using the STRYKER SpineMap® 3D Navigation System.

The surgeon must also refer to the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, or ES2® package insert/instructions for use, product label, and surgical technique guide to obtain detailed product information and recommended surgical procedure.

Device Description

The Navigated XIA® 4.5 Polyaxial Screwdriver, a Stryker Navigated Spine Instrument, is a manual tool for bone screw placement, insertion, and removal. The tip of the navigated screwdriver inserts into the screw head to turn it. The screwdriver also has an interface to allow a connection to the Rotational Navigation Adapter, a Stryker Spine Navigation System accessory, and to a handle.

AI/ML Overview

The provided text is a 510(k) summary for the Navigated XIA® 4.5 Polyaxial Screwdriver. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to predicate devices. However, the document does not contain the specific level of detail required for a comprehensive answer to your request, especially regarding acceptance criteria and the specifics of a study proving device performance against those criteria as you would find for an AI/ML powered device.

This document describes a medical instrument, not an AI/ML powered device. Therefore, many of your requested points (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, ground truth used) are not applicable to this type of submission.

Based on the information provided for this instrument, here's what can be extracted and inferred:

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

Acceptance Criteria	Reported Device Performance
Navigation Accuracy: $\pm$ 2 mm and $\pm$ 2°	Tracking accuracy: 80th percentile < $\pm$ 1.5 mm (Verified against ASTM F2554:2010)
Compatibility with Stryker Spine Navigation System and accessories	Simulated Use in cadaveric setting confirmed functionality with Stryker Spine Navigation System components and accessories.
Functionality as a manual tool for bone screw placement, insertion, and removal	Affirmed through simulated use and similarity to predicate devices. The device interfaces with a handle and has a tip that turns the screw.
No impact on how the spinal screw is placed or removed	Stated that modifications have no impact on this aspect.

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

Test Set Sample Size: Not explicitly stated for the "Simulated Use" or "Navigation Accuracy" tests. The "Simulated Use" mentions a "cadaveric setting," implying a limited number of cadavers were used, but the exact count is not provided. For "Navigation Accuracy," it implies measurements were taken, but the number of measurements or samples is not specified.
Data Provenance: Not explicitly stated. The applicant is Stryker Leibinger GmbH & Co. KG, located in Germany, suggesting testing may have occurred there or at a Stryker facility elsewhere. The nature of the tests (simulated use, bench testing) suggests prospective data collection for these specific tests.

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. For an instrument like this, "ground truth" as it relates to expert consensus on images or diagnoses is not relevant. The "ground truth" for navigation accuracy would be established by precise metrology equipment. For simulated use, the assessment would be by surgical engineers or potentially observing surgeons. No number or specific qualifications of experts are mentioned.

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

Not applicable. Adjudication methods are typically employed in studies involving subjective interpretation (e.g., image reading). For objective performance tests of an instrument, this concept doesn't apply.

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 device is a surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This is a manual surgical instrument. Its "performance" is inherently tied to human action and its interaction with a navigation system. It does not have a standalone algorithmic component in the sense of AI/ML. The navigation system itself performs the calculations, and the instrument's role is to be precisely tracked. The accuracy testing focuses on the instrument's trackability as part of the system.

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

The "ground truth" for the Navigation Accuracy test would be based on physical metrology/measurement standards (e.g., using a coordinate measuring machine or similar high-precision setup to verify the instrument's position and orientation reported by the navigation system against its true physical position). The document refers to verification against ASTM F2554:2010, which specifies methods for testing the accuracy of image-guided surgical systems.

8. The sample size for the training set

Not applicable. As a physical surgical instrument without AI/ML components, it does not have a "training set" in the context of machine learning.

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

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

Summary based on the document:

The Navigated XIA® 4.5 Polyaxial Screwdriver's performance was evaluated through simulated use in a cadaveric setting and navigation accuracy testing. The key acceptance criterion for accuracy was $\pm$ 2 mm and $\pm$ 2°, and the device met this by demonstrating a tracking accuracy of < $\pm$ 1.5 mm (80th percentile) according to ASTM F2554:2010. The device's substantial equivalence was based on its similar technological characteristics and intended use to predicate devices, and the fact that its modifications did not negatively impact its function or the overall navigation system's performance. The specific numbers of cadavers or individual measurements for the tests were not detailed in this summary.

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines representing connection and support.

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

Stryker Leibinger GmbH & Company KG Ms. Becky Ditty Senior Staff Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001

September 4, 2015

Re: K143597

Trade/Device Name: Navigated XIA® 4.5 Polyaxial Screwdriver Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 5, 2015 Received: August 7, 2015

Dear Ms. Ditty:

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

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Page 2 - Ms. Becky Ditty

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/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 yours,

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) K143597

Device Name Navigated XIA® 4.5 Polyaxial Screwdriver

Indications for Use (Describe)

The Stryker Xia 4.5 Polyaxial Screwdriver is a Stryker Navigated Manual Surgical Instrument.

The surgeon must also refer to the Stryker Spine XIA® 3, XIA® 4.5, MANTIS® Redux, or ES2® package insert/instructions for use, product label, and surgical technique guide to obtain detailed product information and recommended surgical procedure.

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

This chapter provides a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Section 5.1 Submitter

Applicant Name:	Stryker Leibinger GmbH & Co. KGBoetzinger Strasse 41D-79111 Freiburg, GermanyPhone number: +49-761-4512117Fax number: +49-761-451249117
Registration No.:	8010177
Name of Contact Person:	Becky DittySr. Staff Regulatory Affairs Specialist4100 E. Milham AveKalamazoo, MI 49001becky.ditty@stryker.com(269) 389-3434
Date Prepared:	September 4, 2015

Section 5.2 Device

Trade Name:	Navigated XIA® 4.5 Polyaxial Screwdriver
Common Name:	Navigated Screwdriver
ClassificationName:	ProductCode	Device	RegulationNumber	Class	ReviewPanel
	PrimaryCodeOLO	OrthopedicStereotaxicInstrument	21 CFR§882.4560	II	Orthopedic
	SecondaryCode: LXH	OrthopedicManualSurgicalInstrument	21 CFR§882.4540	I	Orthopedic

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Section 5.3 Predicate Devices

Trade Name	Stryker Navigation System –Spine & Fluoroscopy Module:Stryker Adapted Smart ManualInstruments (Primary Predicate)	XIA ® 4.5 Polyaxial Screwdriver
510(k) Number	K012380	N/A — Class I/ 510(k) exemptdevice
Product Code	HAW	LXH
Manufacturer	Stryker Leibinger GmbH & Co. KG	Stryker Spine SAS

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

Section 5.4 Device Description

Image /page/4/Figure/6 description: The image shows two different views of a navigated XIA 4.5 polyaxial screwdriver. The top view shows the screwdriver with the text "XIA 4.5 SCREWDRIVER" printed on the side. The bottom view shows the screwdriver with labels pointing to the handle, rotational navigation adapter, instrument tracker, shaft, and bone screw. The figure is labeled as "FIGURE 5-1: NAVIGATED XIA 4.5 POLYAXIAL SCREWDRIVER".

FIGURE 5-2: NAVIGATED XIA 4.5 POLYAXIAL SCREWDRIVER ATTACHED TO ROTATION NAVIGATION ADAPTER, INSTRUMENT TRACKER AND HANDLE

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Section 5.5 Indications for Use

The Stryker Xia 4.5 Polyaxial Screwdriver is a Stryker Navigated Manual Surgical Instrument.

Stryker Navigated Spine Instruments may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative quidance where a reference to a rigid anatomical structure can be identified.

Stryker Navigated Spine Instruments are intended for exclusive use with the Rotational Navigational Adaptor and associated Trackers to facilitate the placement of the pedicle screws of the Stryker Spine XIA® 3, XIA® 4.5, MANTIS® Redux, and ES2® Spinal Fixation Systems using the STRYKER SpineMap® 3D Navigation System.

Section 5.6 Comparison of Technological Characteristics with the Predicate Device

The Navigated XIA 4.5 Polyaxial Screwdriver (subject device) and the predicate devices are intended to be used during the preparation and placement of Stryker Spine screws during spinal surgery, including insertion and removal of bone screws.

The subject and predicate devices have similar technologies, such that the devices interface with a handle and have a tip that the user inserts into the screw head to turn it.

Additionally, the subject device and the Stryker Adapted Smart Manual Instruments predicate device are both designed to interface with Stryker Navigation Systems via the previously cleared Stryker Spine Navigation System accessories: the Rotational Navigation Adapter (K012380) and an Instrument Tracker (K141941). The

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attachment of the Rotational Navigation Adapter and Instrument Tracker to the instrument allows for the localization and navigation of the manual surgical instruments and thus the technology is not included in the subject device itself.

The subject device includes minor design changes as compared to the predicate devices. The main change is a longer shaft to enable the attachment of the Rotational Navigation Adapter; however the subject device also has a modified locking mechanism, and can interface with a wider range of handles.

The instrument modifications detailed in this submission have no impact on the technological characteristics of either the existing instruments or the Stryker Spine Navigation Systems. None of the changes identified affect how the spinal screw is placed or removed. The navigation of the manual instrument is not performed by the instrument itself, but by previously cleared Stryker Spine Navigation System accessories. The accuracy testing provided demonstrates that the Stryker Spine Navigation System accessories (Rotational Navigation Adapter and Instrument Tracker) can be sufficiently connected to the Navigated XIA 4.5 Polyaxial Screwdriver such that the accuracy requirements of the Stryker Spine Navigation System can be achieved.

Section 5.7 Performance Data

The following performance data were provided in support of the substantial equivalence decision:

Test	Description
Simulated Use	Tested the Navigated XIA 4.5 Polyaxial Screwdriver together with theStryker Spine Navigation System and its components and accessories in acadaveric setting according to its requirements.
Navigation Accuracy	Verified the navigation accuracy of $\pm$ 2 mm and $\pm$ 2° of the Navigated XIA4.5 Polyaxial Screwdriver by verifying its tracking accuracy of (80thpercentile < $\pm$ 1.5 mm) according to ASTM F2554:2010.
TABLE 5.1: V&V OVERVIEW

Performance Testing - Bench

Performance Testing - Animal

No animal studies were performed to support substantial equivalence.

Performance Testing - Clinical

No clinical studies were performed to support substantial equivalence.

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Section 5.8 Conclusion

The non-clinical data support the safety of the device and verification and validation demonstrate that the Navigated XIA 4.5 Polyaxial Screwdriver device performs as intended in the specified use conditions. The data also demonstrates that the Navigated XIA 4.5 Polyaxial Screwdriver performs comparably to the predicate devices that are currently marketed for the same intended use.

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).