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 text describes the Zimmer Periarticular Locking Plate System, a medical device for fracture fixation. It includes a summary of safety and effectiveness, indicating that non-clinical performance testing demonstrates the device's safety and effectiveness. However, no specific quantitative or qualitative acceptance criteria are explicitly stated in the document.

Here's an analysis based on the information provided, addressing your requested points:

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

Acceptance Criteria	Reported Device Performance
(Not explicitly stated in the provided document. Typically, these would be biomechanical performance targets such as strength, stiffness, fatigue life, etc., either defined by relevant standards or comparative to a predicate device.)	"The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." (No specific quantitative performance metrics are provided.)

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

The document primarily discusses "non-clinical (laboratory) performance testing." This generally implies mechanical or functional tests performed in a laboratory setting rather than on human or animal subjects that would have a "test set" in the context of diagnostic or predictive algorithms.

Sample Size for Test Set: Not applicable or not specified for non-clinical testing; no information on human or animal test sets.
Data Provenance: "Non-clinical (laboratory) performance testing." No country of origin or retrospective/prospective nature is mentioned as it's not a clinical study.

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)

This question is not applicable to the type of safety and effectiveness data provided. Non-clinical performance testing typically involves engineering or materials scientists performing standardized tests, not medical experts establishing ground truth for diagnostic purposes.

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

Not applicable to non-clinical performance testing as described. Adjudication methods are typically used in clinical studies or studies involving expert assessment of data (e.g., imaging) to establish ground truth or resolve discrepancies.

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

Not applicable. The document describes a medical device (bone plate system) and its non-clinical performance testing, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI assistance are irrelevant to this submission.

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

Not applicable. The device is a physical implant for fracture fixation, not an algorithm.

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

For non-clinical performance testing of a mechanical device, the "ground truth" is typically established by:

Engineering specifications and standards: Performance metrics (e.g., yield strength, fatigue life, torsional rigidity) are measured against predefined engineering requirements or industry standards.
Comparison to predicate device: Performance is often compared to a legally marketed predicate device to demonstrate substantial equivalence.

While not explicitly stated as "ground truth," the tests would be designed to verify that the device meets its design intent and performance characteristics.

8. The sample size for the training set

Not applicable. This is a medical device approval based on non-clinical testing, not a machine learning algorithm that requires a "training set."

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

Not applicable, as there is no "training set" for this type of device submission.

In summary: The provided document is a 510(k) premarket notification for a medical device (a bone plate system). The "study" mentioned refers to "non-clinical (laboratory) performance testing." This type of testing focuses on the mechanical and material properties of the device to ensure it is safe and effective for its intended use, typically by comparing it to a predicate device and meeting engineering standards, rather than involving clinical trials, human data sets, or AI algorithms. As such, many of the questions asked are not applicable to the information contained in this specific document.

Summary

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Image /page/0/Picture/0 description: The image contains the logo for Zimmer Biomet. 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 logo is black and white.

IAN 2 】 2005

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:	December 23, 2004
Trade Name:	Zimmer® Periarticular Locking Plate System
Classification Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Classification Reference:	21 CFR § 888.3030,3040
Predicate 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 Periarticular Locking Plate System is indicatedfor temporary internal fixation and stabilization ofosteotomies and fractures, including comminutedfractures, supracondylar fractures, intra-articularand extra-articular condylar fractures, fractures inosteopenic bone, nonunions, and malunions.
Comparison to Predicate Device:	The Zimmer Periarticular Locking Plate System hasthe same intended use, has similar performancecharacteristics, operates using the same fundamentalscientific technology, is manufactured from thesame materials using the same processes, and issimilar in design to the predicate device.

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Image /page/1/Picture/1 description: The image contains the word "zimmer" in bold, sans-serif font. To the left of the word is a circular logo. The logo contains a stylized letter "Z" inside of a circle.

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.

JAN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043560

Trade/Device Name: Zimmer® Periarticular Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: December 23, 2004 Received: December 27, 2004

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) This letter will anow you to oegill maneting of substantial equivalence of your device to a legally prematics noticate 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 If you desire specific at 1240) 276-0115. Also, please note the regulation entitled, eonidor the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general intermation on your response 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.

Mark A. Melleuson

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 .

Mark A. Milkerer

Division of General, Restorative, and Neurological Devices

510(k) Number K043560

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.