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

This is a 510(k) premarket notification for the Zimmer Periarticular Locking Plate System, which is a medical device for internal fracture fixation. The provided document is a regulatory submission, not a study report detailing acceptance criteria for an AI/CADe device. Therefore, most of the requested information about acceptance criteria, study design, and performance metrics related to AI algorithm evaluation cannot be found here.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not specify "acceptance criteria" in the way it would for an AI algorithm's performance (e.g., sensitivity, specificity thresholds). Instead, for a traditional medical device like a bone plate system, acceptance is based on demonstrating substantial equivalence to a predicate device and showing the device is safe and effective through non-clinical performance data.

Acceptance Criteria (Implied for a 510(k) Submission)	Reported Device Performance
Substantial Equivalence to Predicate Device	Zimmer Periarticular Locking Plate System has the same intended use, similar performance characteristics, is manufactured from identical materials using identical processes, and is similar in design to the predicate devices (K070906).
Safety and Effectiveness Demonstrated by Performance Data	"The results of non-clinical testing show the proposed device is safe and effective."

2. Sample size used for the test set and the data provenance:

Not Applicable. This submission is for a traditional medical device (bone plate system) and refers to non-clinical testing (likely mechanical and material property tests), not a clinical or AI algorithm performance study with a "test set" in the context of diagnostic or prognostic accuracy.
The document implies laboratory-based non-clinical testing rather than human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No ground truth establishment by human experts for a "test set" is described, as this is not an AI/CADe or diagnostic study.

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

Not Applicable. No adjudication method for a test set is described.

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. This is not an AI-assisted diagnostic device; therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or described.

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

Not Applicable. This is not an algorithmic device.

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

Not Applicable (in the context of AI/diagnostic ground truth). The "ground truth" for this device would be established through engineering specifications, material standards, and biomechanical testing results, not through expert consensus, pathology, or outcomes data in the way an AI algorithm's performance is validated.

8. The sample size for the training set:

Not Applicable. This device does not involve a "training set" for an AI algorithm.

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

Not Applicable. This device does not involve a "training set" or corresponding ground truth establishment.

Summary

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Summary of Safety and Effectiveness

NOV = 3 2008

Submitter:	Zimmer. Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Anthony FrancalanciaSenior Associate, Regulatory AffairsTelephone: 574-372-4570Fax: (574) 372-4605
Date:	July 22, 2008
Trade Name:	Zimmer® Periarticular Locking Plate System: DistalHumeral and Proximal Ulna Plates
Common Name:	Periarticular Locking Plates
Classification Name	Plate, Fixation, Bone; Screw, Fixation, Bone
and Reference:	21 CFR § 888. 3030. 888.3040
Predicate Device:	Zimmer Periarticular Locking Plate System:Distal Lateral Fibular Plates and Screws,K070906, cleared May 1, 2007
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:· Comminuted fractures· Supracondylar fractures• Intra-articular and extra-articular condylarfractures· Fractures in osteopenic bone· Nonunions· Malunions

・・・。

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Comparison to Predicate Device:

The Zimmer Periarticular Locking Platc System has the same intended use, has similar performance characteristics, is manufactured from identical materials using identical processes, and is similar in design to the predicate devices.

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

The results of non-clinical testing show the proposed device is safe and effective.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2008

Zimmer, Inc. % Mr. Anthony Francalancia Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K082078 Trade/Device Name: Zimmer® Periarticular Locking Plate System: Distal Humeral and Proximal Ulna Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: October 27, 2008 Received: October 28, 2008

Dear Mr. Francalancia:

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

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Page 2 - Mr. Anthony Francalancia

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.

መሆኑን የሚገኝ የሚገኝ የሚገኝ የሚገኝ የሚገኝ የሚገኝ የሚገኝ የተወለደው የአማርኛ ምሳሌ ነው። ትርጉሙ ያልተተረጎመ ምሳሌ ተረት

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Mikkelson

Mark N. Melkerson 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): K082678

Device Name:

Zimmer® Periarticular Locking Plate System: Distal Humeral and Proximal Ulna Plates

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

1 3121 - 117 Division of General, Restorative. and Neurological Devics

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510(k) Number K082078

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.