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

AI/ML Overview

The provided document is a 510(k) summary for the Zimmer Periarticular Locking Plates, a device for internal fracture fixation. It describes the device, its intended use, comparison to predicate devices, and a general statement about performance data.

However, the document does not contain the detailed information necessary to answer the specific questions about acceptance criteria, a study proving device meeting criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The "Performance Data" section states: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." This is a high-level summary and does not provide any specific quantitative acceptance criteria or detailed study results.

Therefore, I cannot populate the table or provide answers to most of the questions based on the provided text.

Here's what can be inferred or directly stated from the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not specified in the document.
Reported Device Performance: The document generally states "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." No specific metrics (e.g., tensile strength, fatigue life, torsional stability) or quantitative results are provided.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified quantitatively, only general statement of "safe and effective" based on non-clinical (laboratory) testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "non-clinical (laboratory) performance testing." It does not specify sample sizes for test sets, data provenance, or whether the study was retrospective or prospective.

3. 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/Not mentioned. The testing described is "non-clinical (laboratory) performance testing," which typically involves mechanical or material property assessments, not expert-reviewed data where "ground truth" for diagnostic or clinical accuracy is established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned for the same reasons as #3.

5. 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 is a medical device (bone plate and screw system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. As this is a non-clinical, laboratory performance test of a physical device, the "ground truth" would likely refer to established engineering standards or physical test outcomes (e.g., measuring forces, displacements, fatigue cycles). Specific details are not provided.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not a machine learning model.

Summary

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

K042598

OCT 2 9 2004	Summary of Safety and Effectiveness
Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Noah J. Bartsch, MSSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8552Fax: (574) 372-4605
Date:	September 22, 2004
Trade Name:	Zimmer® Periarticular Locking Plates
Classification Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Classification Reference:	21 CFR § 888.3030,3040
Predicate Devices:	Zimmer® Periarticular Locking Plate SystemK040593, cleared April 12, 2004
	Synthes Locking Condylar Plate (LCP) System –4.5mm LCP Condylar Plate, K000066, clearedMarch 15, 2000
	Zimmer® ECT® Internal Fracture Fixation System,Preamendments Device
	Synthes LCP System - 3.5/4.5mm LCPMetaphyseal Plate System, K033805, clearedFebruary 20, 2004
	Zimmer® Magna-Fx® Cannulated Screw FixationSystem, Preamendments Device
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 to
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 Devices:	The Zimmer Periarticular Locking Plate System hasthe same intended use, has similar performancecharacteristics, is manufactured from similarmaterials using similar processes, and is similar indesign to the predicate devices.
Performance Data:	The results of non-clinical (laboratory) performancetesting demonstrate that the device is safe andeffective.

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

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2004

Mr. Noah J. Bartsch, MS Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581

Re: K042598

Trade/Device Name: Zimmer® Periarticular Locking System Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: September 22, 2004 Received: September 23, 2004

Dear Mr. Bartsch:

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

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Page 2 - Mr. Noah J. Bartsch, MS

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.

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/dsma/dsmamain.html

Sincerely vours.

sincerely, yours,

L. Mark X. Mellum

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® 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 .

L. Mark A. Mchuson

Division of General, Restorative, and Neurological Devices

510(k) Number K042598

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)

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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.