The Stryker ESSx with Navigation Mount is to be utilized for Functional Endoscopic Sinus Surgery (FESS) for the incision of soft and osseous tissue in the sinus cavities, open plastic, reconstructive and aesthetic surgery of the Head and Neck. When used in conjunction with the Stryker Navigation/Tracker System, the device will enhance the surgeon's ability to localize anatomical landmarks (intraoperatively).

Device Description

The Stryker ESSx with Navigation Mount is an electric, high-speed instrument system consisting of a motor (handpiece), hoses, and a variety of attachments and cutting accessories. The handpiece will operate with FDA cleared Stryker Navigation Systems. The Navigation feature will serve as a secondary verification to the tips position which is obtained through visual means typically with use of an endoscope.

AI/ML Overview

The provided document describes a 510(k) Summary for a medical device called the "Stryker ESSx with Navigation Mount." This type of submission to the FDA is for demonstrating substantial equivalence to pre-existing legally marketed devices, not for proving a device meets specific performance acceptance criteria through clinical studies in the same way a PMA (Pre-Market Approval) or de novo device might.

Therefore, many of the detailed questions regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, and MRMC studies are not applicable to this 510(k) submission. The FDA approval here is based on a comparison to predicate devices, not on a detailed performance study against specific acceptance criteria.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated for this 510(k))	Reported Device Performance (Summary of Equivalence)
Specific performance metrics (e.g., accuracy, precision, speed, safety in randomized trials) are not provided in this 510(k) summary.	The Stryker ESSx with Navigation Mount has the same intended use, technological characteristics, and navigated operating mechanism as the predicate devices: Diego Powered Dissector Handpiece with Starlink Image Guided Adapter Mounting Interface (K030343) and Xomed XPS 3000 System (K041523). It also has the same intended use as the Stryker Hummer IV MicroDebrider System (K011381).
Numerical acceptance criteria (ee.g., X% accuracy, Y-second speed) are not part of a substantial equivalence claim.	The device is considered substantially equivalent to legally marketed devices based on this comparison.

Reasoning for Absence: 510(k) submissions primarily focus on demonstrating substantial equivalence to legally marketed predicate devices. They typically do not require the rigorous, pre-defined performance acceptance criteria and associated clinical study data that would be found in a De Novo submission or a PMA for a novel device. The "acceptance criteria" in this context are implicitly met if the device is found to be substantially equivalent to predicates that have already demonstrated safety and effectiveness.

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

Not applicable / Not explicitly stated. This 510(k) summary relies on a comparison to predicate devices, not on a new clinical study with a "test set" in the traditional sense. The data provenance would be the existing documentation for the predicate devices.

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

Not applicable. No new "test set" requiring ground truth establishment by experts is described in this 510(k) summary. The document does mention that the "Navigation feature will serve as a secondary verification to the tips position which is obtained through visual means typically with use of an endoscope." This implies existing clinical practice and expertise, but not a specific set of experts for a new study's ground truth.

4. Adjudication Method for the Test Set

Not applicable. No new "test set" requiring an adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. Such studies are typically part of more extensive clinical evaluations, not standard for an equivalence claim.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable / Not explicitly stated. The device is an "electric, high-speed instrument system" and not an AI algorithm. Its navigation feature works "in conjunction with the Stryker Navigation/Tracker System" to "enhance the surgeon's ability to localize anatomical landmarks." This inherently involves a human-in-the-loop (the surgeon) performing the procedure. A "standalone" performance for an instrument with a navigation mount doesn't fit the typical definition of an algorithm's standalone performance.

7. The Type of Ground Truth Used

Implicitly, the established safety and effectiveness of the predicate devices. For the specific function of the navigation feature, the document states it "will serve as a secondary verification to the tips position which is obtained through visual means typically with use of an endoscope." This suggests that the "ground truth" for tip position during surgical use relies on the surgeon's visual assessment, often aided by an endoscope. However, this is for real-world surgical application, not a controlled study's ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is an instrument system, not an AI algorithm that requires a "training set" of data.

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

Not applicable. No training set is involved for this type of device.

Summary of the 510(k) Approach:

The Stryker ESSx with Navigation Mount received FDA clearance based on substantial equivalence to existing, legally marketed predicate devices. This means that the FDA determined the device is safe and effective because it has the same or very similar intended use and technological characteristics to devices already on the market. The justification for equivalence is presented by comparing the new device's features and intended use to those of three predicate devices. This regulatory pathway bypasses the need for extensive new clinical trials with pre-defined acceptance criteria, explicit sample sizes, or ground truth establishment for a novel study, as these aspects were already addressed (or deemed not necessary) for the predicate devices.

Summary

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510(k) Summary
Device Sponsor:	Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700 ext4233(f) 269-324-5412
Registration No.:	1811755
Trade Name:	Stryker ESSx with Navigation Mount
Common Name:	Surgical ENT Drill with Accessories
Classification Name:	Drill, Surgical, ENT (electric or pneumatic) including Handpiece
Equivalent to:	K011381 Stryker Hummer IV MicroDebrider SystemK030343 Diego Powered Dissector Handpiece with Starlink Image Guided Adapter Mounting InterfaceK041523 XPS 3000 System
Device Description:	The Stryker ESSx with Navigation Mount is an electric, high-speed instrument system consisting of a motor (handpiece), hoses, and a variety of attachments and cutting accessories. The handpiece will operate with FDA cleared Stryker Navigation Systems. The Navigation feature will serve as a secondary verification to the tips position which is obtained through visual means typically with use of an endoscope.
Indications for Use:	The Stryker ESSx with Navigation Mount is to be utilized for Functional Endoscopic Sinus Surgery (FESS) for the incision of soft and osseous tissue in the sinus cavities, open plastic, reconstructive and aesthetic surgery of the Head and Neck. When used in conjunction with the Stryker Navigation/Tracker System, the device will enhance the surgeon's ability to localize anatomical landmarks (intraoperatively).
Substantial Equivalence (SE) Rational:	The Stryker ESSx with Navigation Mount has the same intended use, technological characteristics and navigated operating mechanism as compared to the predicate devices: the Diego Powered Dissector Handpiece with Starlink Image Guided Adapter Mounting Interface (K030343) and the Xomed XPS 3000 System (K041523). The Stryker ESSx with Navigation Mount has the same intended use as the Stryker Hummer IV MicroDebrider System (K011381).
Safety and Effectiveness:	Based upon the comparison to the predicate devices, the Stryker ESSx with Navigation Mount is substantially equivalent to legally marketed devices.
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Submitted by:

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Valerie Franck Senior Regulatory Affairs Representative

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11:10 PM

9/30/08_

Date submitted:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 02 2008

Stryker Corp. c/o Valerie Franck 4100 East Milham Ave. Kalamazoo, MI 49001

Re: K080052

Trade/Device Name: Stryker ESSx with Navigation Mount Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose and Throat (electric or pneumatic) surgical drill Regulatory Class: Class II Product Code: ERL Dated: September 12, 2008 Received: September 15, 2008

Dear Ms. Franck:

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 gencral 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 (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.

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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 at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Egerlino, mD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known):

080052

Page 1 of 1

Device Name: Stryker ESSx with Navigation Mount

Indications for Use

Prescription Use × (Part 21 CFR 801 Subpart D)

and/or

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

x
Prescription Use
(Per 21 CFR 801.109)

Sein Machen

(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises

2057 510(k) Number.

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.