Zimmer Ortho Guidance Systems Hip Instruments can be used as accessories to Image Guided Surgery systems and are indicated for any hip orthopaedic 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 or pelvis, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures for these instruments include, but are not limited to:

Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopaedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization or Repair of Pelvic/Femoral Fractures

Device Description

The Zimmer Ortho Guidance Hip Instruments are orthopaedic manual instruments modified to accept a Medtronic Image Guidance System array and are to be used with the Medtronic StealthStation® System.

AI/ML Overview

This document describes the Zimmer Ortho Guidance™ Systems – Hip Instruments. Based on the provided text, the device is an accessory to Image Guided Surgery systems.

Here's an analysis of the provided information, specifically addressing the requested points:

Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria (e.g., accuracy thresholds, precision values) or report specific performance metrics for the Zimmer Ortho Guidance™ Systems – Hip Instruments. It states: "No guidance documents exist for these instruments. QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems." This implies that the validation focuses on compliance with Quality System Regulations (QSR) rather than direct performance measurement against pre-defined acceptance criteria for the instruments' clinical function.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No test set details are provided. The document explicitly states: "Clinical data and conclusions were not needed for this devices."
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, as no clinical or performance testing data is presented, and no ground truth establishment is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical or performance testing data is presented.
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. The device described is an orthopaedic instrument, not an AI-powered diagnostic or assistive tool, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is an instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical or performance testing data is presented that would require ground truth.
The sample size for the training set
Not applicable, as this is an instrument and not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established
Not applicable, as this is an instrument and not a machine learning algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided document, there was no clinical study or specific performance study conducted to "prove the device meets acceptance criteria" in terms of clinical effectiveness or diagnostic performance. The submission for the Zimmer Ortho Guidance™ Systems – Hip Instruments was a 510(k) premarket notification. The review concluded that the device is "substantially equivalent" to a legally marketed predicate device (Catheter Introducer for the StealthStation System manufactured by Medtronic Surgical Navigation, K022126).

The document states:

"No guidance documents exist for these instruments."
"QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems." (This refers to manufacturing and quality control, not clinical performance.)
"Clinical data and conclusions were not needed for this devices."

Therefore, the "study" that proves the device meets acceptance criteria in the context of this 510(k) submission is the demonstration of substantial equivalence to a predicate device, as determined by the FDA, without the need for new clinical performance data for the instruments themselves. The acceptance criteria were primarily met through the regulatory pathway of substantial equivalence based on device description and intended use, rather than a novel performance study.

Summary

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Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Karen CainManager, Regulatory AffairsTelephone: (574) 372-4219Fax: (574) 372-4605
Date:	October 3, 2003
Trade Name:	Zimmer Ortho Guidance™ Systems – HipInstruments
Common Name:	Image Guided Instrument
Classification Nameand Reference:	Stereotaxic Instrument21 CFR § 888.4560
Predicate Device:	Catheter Introducer for the StealthStation Systemmanufactured by Medtronic Surgical NavigationTechnologies, K022126, cleared January 3, 2003.
Device Description:	The Zimmer Ortho Guidance Hip Instruments areorthopaedic manual instruments modified to accepta Medtronic Image Guidance System array and areto be used with the Medtronic StealthStation®System.
Intended Use:	Zimmer Ortho Guidance Hip Instruments can beused as accessories to Image Guided Surgerysystems and are indicated for any hip orthopaedicmedical condition resulting from disease or traumain which the use of stereotaxic surgery may beappropriate, and where reference to a rigidanatomical structure, such as a long bone or pelvis,can be identified relative to a CT or MR basedmodel or fluoroscopy images of the anatomy.Example procedures for these instruments include,but are not limited to:

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Image /page/1/Picture/0 description: The image shows the Zimmer logo. The logo consists of a stylized letter Z inside of a circle, followed by the word "Zimmer" in a simple, sans-serif font. The letter Z and the word "Zimmer" are both in black, while the circle is white with a black outline.

Traditional 510(k) Premarket Notification

Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopaedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization of Repair of Pelvic/Femoral Fractures

The proposed devices can be used as accessory instruments (like the predicate). Both predicate and proposed devices are indicated for use with Image Guidance Surgery Systems.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

No guidance documents exist for these instruments. 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 this devices.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2004

Ms. Karen Cain Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K033223

Trade/Device Name: Zimmer Ortho Guidance™ Systems – Hip Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Codc: HAW Dated: December 11, 2003 Received: December 12, 2003

Dear Ms. Cain:

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 complics 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. Karen Cain

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 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.

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):

K033223

Device Name:

Zimmer Ortho Guidance" Systems - Hip Instruments

Indications for Use:

Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopaedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization or Repair of Pelvic/Femoral Fractures

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)

Concellers Edit GDBH Agics of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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K033 22.3 510(k) Number

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).