The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Zimmer® Periarticular Locking Plate System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical or AI-specific performance studies with acceptance criteria, sample sizes, or ground truth as you've requested for an AI/algorithm-based device.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Performance Data" section explicitly states: "The results of non-clinical analysis demonstrate that the device is safe and effective." This refers to mechanical testing or other non-clinical evaluations typical for an orthopedic implant, not to a performance study for an AI-enabled device.

To directly answer your questions based only on the provided text, the response would be:

This document is a 510(k) Premarket Notification for a traditional medical device (bone plate and screw system), not an AI/algorithm-enabled device. As such, it does not contain the information requested regarding acceptance criteria for an algorithm, study design elements for an AI performance evaluation (such as sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance), or how ground truth was established for such a study. The document states that "non-clinical analysis demonstrate that the device is safe and effective," referring to engineering or mechanical testing, not an algorithmic performance study.

Summary

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JUL 7 - 2005

K051098 p 1/2
Traditional 510(k) Premarket Notification

Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Laura D. Williams, RACManager, Corporate Regulatory AffairsTelephone: (574) 372-4523Fax: (574) 372-4605
Date:	April 29, 2005
Trade Name:	Zimmer® Periarticular Locking Plate System
Classification Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Classification Reference:	21 CFR § 888.3030,3040
Predicate Device:	Zimmer ECT® Internal Fracture Fixation System,Preamendment Device
	Zimmer Periarticular Locking Plate System,K040593, cleared April 12, 2004
Device Description:	The Zimmer Periarticular Locking Plate System is aplate and screw system intended for internalfracture fixation. The low-profile periarticularlocking plate is anatomically contoured and hasthreaded holes which accept locking screws tocreate a stable, fixed angle construct.
Intended Use:	The Zimmer Periarticular Locking Plate System isindicated for temporary internal fixation andstabilization of osteotomies and fractures, includingcomminuted fractures, supracondylar fractures,intra-articular and extra-articular condylar fractures,fractures in osteopenic bone, nonunions, andmalunions.
Comparison to Predicate Device:	The Zimmer Periarticular Locking Plate System hasthe same intended use, has similar performancecharacteristics, is manufactured from similar

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materials using similar processes, and is similar in design to the predicate devices.

Performance Data:

The results of non-clinical analysis demonstrate that the device is safe and effective.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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JUL 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura D. Williams, RAC Manager, Corporate Regulatory Affairs Zimmer Incorporated P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K051098 Trade/Device Name: Zimmer® Periarticular Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC Dated: April 29, 2005 Received: May 2, 2005

Dear Ms. Williams:

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. Laura D. Williams, RAC

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 (240) 276-0120 . 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,

Hypt Clurke

m C. Provost, Ph.D. 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

510(k) Number (if known):

Device Name:

Zimmer® Periarticular Locking Plate System

Indications for Use:

The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

Comminuted fractures .
. Supracondylar fractures
Intra-articular and extra-articular condylar fractures .
. Fractures in osteopenic bone
. Nonunions
Malunions . .

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

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

0017

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Concurrence of CDRH, Office of Device Evaluation (DDE)

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	(Division Sign-Off)
	Division of General, Restorative, and Neurological Devices
510(k) Number	K051088

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.