Zimmer Knee Computer Assisted Solutions 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, fluoroscopy images, or digitized landmarks 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 that have a slot that accommodates a Medtronic electromagnetic tracking sensor, and
• The addition of digitized landmark (imageless) referencing to the indications for use for both optical and electromagnetic tracking sensors.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Zimmer® Computer Assisted Solutions - Electromagnetic and Imageless Knee Instrumentation, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly defines the acceptance criterion as demonstrating accuracy validation and verification for the instruments when used with Medtronic StealthStation Image Guidance Systems. The "Performance Data (Nonclinical and/or Clinical)" section is where this would be addressed.

Acceptance Criteria Category	Specific Criteria (Implicit from document)	Reported Device Performance
Accuracy Validation	Instruments demonstrate accuracy when used in conjunction with Medtronic StealthStation Image Guidance Systems.	Accuracy validation and verification testing was conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems. (This statement indicates the device met this implicit criterion.)
Verification Testing	Instruments undergo verification testing.	Accuracy validation and verification testing was conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems. (Similar to above, this confirms verification testing was performed.)

Study Details

This submission is for modifications to existing instruments (accommodating an electromagnetic tracking sensor and adding imageless referencing). The provided document is a 510(k) summary, which often relies heavily on substantially equivalent predicates and non-clinical testing for accessories.

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a distinct "test set" sample size in terms of number of cases or patients. The testing was non-clinical performance and conclusions. This suggests testing in a lab or simulated environment rather than on human subjects.
- Data Provenance: Not applicable for clinical provenance as the study was non-clinical. The testing was conducted for instruments manufactured by Zimmer, Inc., which implies internal testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this was non-clinical accuracy validation and verification testing of instruments, expert human interpretation of images for ground truth was not required. The ground truth would likely be established by known physical measurements or established engineering standards.
Adjudication method for the test set:
- Not applicable. Given the non-clinical nature of the testing, a human adjudication method (like 2+1 or 3+1) is not relevant.
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. This device is an instrument for computer-assisted surgery, not an AI-powered diagnostic imaging tool that would typically involve human "readers" or an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The accuracy validation and verification testing of the instruments themselves would be standalone in demonstrating their performance. The instruments are accessories to Image Guided Surgery systems, meaning they perform their function (tracking, guiding) independent of human interpretation of the instrument's output for ground truth.
The type of ground truth used:
- The document implies that the ground truth for the non-clinical accuracy validation and verification testing would be engineering measurements or established physical benchmarks. For example, the accuracy of tracking systems typically relies on known spatial coordinates or precise mechanical measurements.
The sample size for the training set:
- Not applicable. This device is an instrument, not a machine learning algorithm that requires a "training set" in the conventional sense. Its functionality is based on known physical principles and engineering design.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

Summary

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DEC 2 8 2005

Summary of Safety and Effectiveness

K052425

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Stephen H. McKelveyManager, Corporate Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 372-4605
Date:	September 1, 2005
Trade Name:	Zimmer® Computer Assisted Solutions -Electromagnetic and Imageless KneeInstrumentation
Common Name:	Image Guided Instrument
Classification Nameand Reference:	Stereotaxic Instrument21 CFR § 882.4560
Predicate Device:	Zimmer Ortho Guidance Systems - KneeInstruments, manufactured by Zimmer, Inc.,K033011, cleared February 12, 2004.
Device Description:	This submission is for:
	• Zimmer orthopedic manual knee instrumentsthat have a slot that accommodates a Medtronicelectromagnetic tracking sensor, and• The addition of digitized landmark (imageless)referencing to the indications for use for bothoptical and electromagnetic tracking sensors.
Intended Use:	Zimmer Knee Computer Assisted SolutionsInstruments are intended as accessories to ImageGuided Surgery systems and are indicated for anyknee orthopedic medical condition in which the useof stereotaxic surgery may be appropriate, andwhere reference to a rigid anatomical structure, suchas a long bone, can be identified relative to a CT orMR based model, fluoroscopy images, or digitized

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landmarks 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

Both the predicate and proposed devices are indicated for use with image guidance surgery systems. Both are accessory instruments.

Non-Clinical Performance and Conclusions:

Accuracy validation and verification testing was conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A." is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 8 2005

Mr. Stephen H. McKelvey, MA, RAC Manager, Corporate Regulatory Affairs Zimmer, Inc. 345 East Main Street Warsaw, Indiana 46581-0708

Re: K052425

K032425
Trade/Device Name: Zimmer® Computer Assisted Solutions-Electromagnetic and Imageless Knee Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 15, 2005 Received: December 19, 2005

Dear Mr. McKelvey:

We have reviewed your Section 510(k) premarket notification of intent to market the device t we nave reviewed your bection 910(x) proximatially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encrosure) to regary inate of the Medical Device Amendments, or to devices that prior to May 20, 1770, the onactions with the provisions of the Federal Food, Drug, and Cosmetic Italy bech recuired in accordinal of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mance mo device, sabject to an essent of annual registration, listing of devices, good controls provibitions or and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sublicitions. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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 I DA mas muse a were mations 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 iaceming (DS) 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 promaticate 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 Office of Compliance at (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Barbara Bouchard

Mark N. Melkerson Acting 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

KOSSHAS 510(k) Number (if known):

Device Name:

Zimmer® Computer Assisted Solutions - Electromagnetic and Imageless Knee Instrumentation

Indications for Use:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty (Primary and Revision) Minimally Invasive Knee 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)

5245 Barbara Buend
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number K052425

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).