Zimmer Knee Ortho Guidance Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty (Primary and Revision) Minimally Invasive Knee Orthopedic Procedures

Device Description

This submission is for Zimmer orthopedic manual knee instruments modified to accept an Medtronic Image Guidance System (IGS) array and to be used with the Medtronic StealthStation® System

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the Zimmer Ortho Guidance Systems - Knee Instruments:

The provided document describes a 510(k) premarket notification for Zimmer Ortho Guidance Systems - Knee Instruments. These instruments are accessories intended to be used with the Medtronic StealthStation® Image Guidance System.

Based on the information provided in the 510(k) summary, the device is a manual knee instrument modified to accept an Medtronic Image Guidance System (IGS) array. This is not an AI/ML powered device, therefore, many of the requested criteria related to AI/ML device studies (such as MRMC studies, stand-alone performance, training set details, and expert ground truth establishment for AI performance) are not applicable.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence:

The primary acceptance criteria for this 510(k) submission was to demonstrate substantial equivalence to a legally marketed predicate device. This involved showing that the new device has the same intended use, similar technological characteristics, and does not raise different questions of safety and effectiveness compared to the predicate device.

Acceptance Criteria	Reported Device Performance
Intended Use	"Zimmer Knee Ortho Guidance Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee orthopedic medical condition in which the use of stereotaxic surgery may be appropriate... Example orthopedic procedures for these instruments include, but are not limited to: Total Knee Arthroplasty (Primary and Revision), Unicompartmental Knee Arthroplasty (Primary and Revision), Minimally Invasive Knee Orthopedic Procedures." The document states: "Both the predicate and proposed devices are indicated for use with Image Guidance Surgery systems. Both are accessory instruments."
Technological Characteristics (Material, Design, Energy, Performance, etc.)	The device is described as "Zimmer orthopedic manual knee instruments modified to accept an Medtronic Image Guidance System (IGS) array and to be used with the Medtronic StealthStation® System." The document implies that the core function of the knee instrument remains the same, with the modification being its compatibility with the image guidance system.
Safety & Effectiveness	No specific performance metrics for safety or effectiveness are provided, as the submission relies on substantial equivalence and the predicate's established performance. The document states: "No testing was needed for these devices. QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems." And "Clinical data and conclusions were not needed for these devices."

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

Not Applicable (N/A): No formal test set, clinical data, or performance studies are described in this 510(k) summary for the device itself. The submission states, "No testing was needed for these devices." and "Clinical data and conclusions were not needed for these devices." This indicates that the substantial equivalence was based on design comparison and intended use, rather than a performance study requiring a test set.

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

Not Applicable (N/A): As no test set performance study was conducted, there were no experts required for ground truth establishment.

4. Adjudication Method for the Test Set

Not Applicable (N/A): No test set performance study was conducted.

5. If an MRMC Comparative Effectiveness Study was Done

No: This is not an AI/ML device, and no MRMC study was described. The device is a physical surgical instrument.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

No: This is not an AI/ML algorithm; it is a surgical instrument. Therefore, a standalone algorithm performance study is not relevant or applicable.

7. The Type of Ground Truth Used

Not Applicable (N/A): No ground truth was established for device performance as part of this 510(k) submission. The FDA cleared the device based on substantial equivalence to the predicate device (Catheter Introducer for the StealthStation System, K022126). The "ground truth" for clearance was the established safety and effectiveness of the predicate device in conjunction with the image guidance system.

8. The Sample Size for the Training Set

Not Applicable (N/A): There is no AI/ML component described, therefore no training set was used.

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

Not Applicable (N/A): There is no AI/ML component described, therefore no training set or associated ground truth establishment process.

In summary, the 510(k) for the Zimmer Ortho Guidance Systems - Knee Instruments relied on demonstrating substantial equivalence to a predicate device rather than conducting new performance studies. Therefore, most of the detailed questions regarding study design, sample sizes, and ground truth establishment (which are common for AI/ML or novel device performance studies) are not applicable in this context.

Summary

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Ko33011

Image /page/0/Picture/1 description: The image shows the Zimmer logo. The logo consists of a stylized letter Z inside a circle, followed by the word "zimmer" in a bold, sans-serif font. The letter Z is black, and the word "zimmer" is also black.

Traditional 510(k) Premarket Notification

FEB 1 2 2004

Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Stephen McKelveyManager, Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 372-4605
Date:	September 25, 2003
Trade Name:	Zimmer Ortho Guidance Systems - KneeInstruments
Common Name:	Image Guided Instrument
Classification Nameand Reference:	Stercotaxic Instrument21 CFR § 882.4560
Predicate Device:	Catheter Introducer for the StealthStation System,manufactured by Medtronic Surgical NavigationTechnologies, K022126, cleared January 3, 2003.
Device Description:	This submission is for Zimmer orthopedic manualknee instruments modified to accept an MedtronicImage Guidance System (IGS) array and to be usedwith the Medtronic StealthStation® System
Intended Use:	Zimmer Knee Ortho Guidance Instruments areintended as accessories to Image Guided Surgerysystems and are indicated for any knee orthopedicmedical condition in which the use of stereotaxicsurgery may be appropriate, and where reference toa rigid anatomical structure, such as a long bone,can be identified relative to a CT or MR basedmodel or fluoroscopy images of the anatomy.Example orthopedic procedures for theseinstruments include, but are not limited to:

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Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in a smaller, sans-serif font. The letter "Z" is black, and the word "zimmer" is also black.

Traditional 510(k) Premarket Notification

ﺖ Total Knee Arthroplasty (Primary and Revision)
-Unicompartmental Knee Arthroplasty (Primary and Revision)
Minimally Invasive Knee Orthopedic -Procedures

Both the predicate and proposed devices are indicated for use with Image Guidance Surgery systems. Both are accessory instruments.

Non-Clinical Performance and Conclusions:

No testing was needed for these devices. QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for these devices.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2004

Mr. Stephen H. McKclvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K033011

Trade/Device Name: Zimmer Ortho Guidance Systems - Knee Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 10, 2003 Received: December 11, 2003

Dear Mr. McKelvey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 madc 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 - Mr. Stephen II. McKelvey

This letter will allow you to begin marketing your device as described in your Scetion 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promatted 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 11 you t the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

C. Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Zimmer Ortho Guidance Systems - Knee Instruments

Indications for Use:

Zimmer Knee Ortho Guidance Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee orthopedic medical condition in which the Burgery systems and are may be appropriate, and where reference to a rigid anatomical use of stereoumn's a long bone, can be identified relative to a CT or MR based model or Straters of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knce Arthroplasty (Primary and Revision) Minimally Invasive Knec Orthopedic Procedures

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division of General, Restorative. and Neurological Devices

Page 1 of 1

510(k) Number K033011

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).