STRYKER POWER TOOL NAVIGATOR ATTACHMENT by STRYKER CORP.

The Stryker® Power Tool Navigator attachment is intended to enable spatial localization and identification of Stryker Power Tools by the Stryker® Navigation System.

Device Description

The Stryker® Power Tool Navigator (PTN) attachment is a tracking device designed for use with Stryker Surgical Power Tools. The PTN attachment is an optical surgical navigation tracker that attaches to a power tool, allowing that tool to be tracked by a Stryker Navigation System. The device employs an array of optical IR LEDs and an IR communications link to interface with the Navigation System.

AI/ML Overview

This document is a 510(k) premarket notification for the Stryker® Power Tool Navigator. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a detailed study with acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance are not available in the provided text.

Based on the information provided:

A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the 510(k) summary. The document states that the "Stryker® Power Tool Navigator attachment does not raise any new safety and efficacy concerns when compared to a similar device already legally marketed." This implies that the acceptance criteria are met if the device is found to be substantially equivalent to predicates, meaning its performance is considered comparable and acceptable without specific numerical thresholds being outlined in this summary.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The 510(k) summary does not describe a performance study with a distinct test set.
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)
This information is not provided. No "ground truth" establishment for a test set is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
No MRMC comparative effectiveness study is mentioned. The device is a "Power Tool Navigator" which is an optical tracking device for surgical tools, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device described is a hardware attachment for surgical power tools that enables spatial localization. It is not an algorithm in the sense of an AI or diagnostic software. Its functionality is to track tools, which inherently involves interaction within a larger "Navigation System." Therefore, a standalone algorithm performance evaluation in the typical sense (e.g., for an AI diagnostic tool) is not applicable or described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided, as no specific performance study with a ground truth is described.
The sample size for the training set
This information is not provided. No "training set" in the context of machine learning is applicable or mentioned for this hardware device.
How the ground truth for the training set was established
This information is not provided, as no training set or its ground truth establishment is mentioned.

Summary of the Study (as described in the 510(k) content):

The "study" presented in this document is a substantial equivalence (SE) rational rather than a traditional performance study with specific acceptance criteria and detailed quantitative results.

Rationale for Substantial Equivalence: The primary "study" or justification for clearance is that the Stryker® Power Tool Navigator attachment is equivalent in "intended use, safety, and effectiveness" to existing, legally marketed Stryker devices (K993239 Stryker® Navigation System - Neuro Module, K010204 Stryker® Navigation System - KneeTrack Module, K022365 Stryker® Navigation System - Hip Module). The document explicitly states that it "does not raise any new safety and efficacy concerns" compared to these predicate devices.
Safety and Effectiveness: The device is designed and manufactured in accordance with Stryker Instrument's Quality Management System covered by QSR 21CFR 820. This indicates adherence to established quality and manufacturing standards, which contribute to safety and effectiveness.

In conclusion, this 510(k) submission seeks clearance based on demonstrating that the new device is fundamentally similar to existing, cleared devices, rather than through a novel performance study with specific, quantifiable acceptance criteria.

Summary

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4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 f: 269 324 5412
www.stryker.com

JUL 1 7 2008

stryker

14080450

510(k) Summary
Device Sponsor:	Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412
Registration No .:	1811755
Trade Name:	Stryker® Power Tool Navigator
Common Name:	Power Tool Navigator
Classification Name:	Stereotaxic Instruments
Equivalent to:	K993239 Stryker® Navigation System - Neuro ModuleK010204 Stryker® Navigation System - KneeTrack ModuleK022365 Stryker® Navigation System - Hip Module
Device Description:	The Stryker® Power Tool Navigator (PTN) attachment is a tracking device designedfor use with Stryker Surgical Power Tools. The PTN attachment is an optical surgicalnavigation tracker that attaches to a power tool, allowing that tool to be tracked by aStryker Navigation System. The device employs an array of optical IR LEDs and an IRcommunications link to interface with the Navigation System.
Indications for Use:	Stryker® Power Tool Navigator attachment is intended to enable spatial localizationand identification of Stryker Power Tools by the Stryker® Navigation System
Substantial Equivalence(SE) Rational:	Stryker® Power Tool Navigator attachment is equivalent in intended use, safety, andeffectiveness to existing devices being marketed by Stryker.
Safety and Effectiveness:	The Stryker® Power Tool Navigator attachment does not raise any new safety andefficacy concerns when compared to a similar device already legally marketed. TheStryker® Power Tool Navigator attachment is, therefore, substantially equivalent to theexisting device. Stryker® Power Tool Navigator attachment is designed andmanufactured in accordance with Stryker Instrument's Quality Management Systemcovered by QSR 21CFR 820.
Submitted by:	Becky DittySenior Regulatory Affairs Representative

Signature
2/15/18Date Submitted:

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Public Health Service

JUL 1 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Corporation % Ms. Becky Ditty Regulatory Analyst 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K080450

Trade/Device Name: Stryker® Power Tool Navigation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 16, 2008 Received: June 19, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Ms. Becky Ditty

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems ম্ম (240) 276-3464. You may otuain 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mullein

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: Stryker® Power Tool Navigator

Indications for Use

The Stryker® Power Tool Navigator attachment is intended to enable spatial localization and identification of Stryker Power Tools by the Stryker® Navigation System.

Prescription Use	X	and/or	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)

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

(Division Sign-Off)

Division of General Restorative Device Evaluation (ODE)

and Neurological Devices

510(k) Number	L080480
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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).