The Zimmer Universal Locking System is a plate and screw system intended for internal fracture fixation. The plate selection consists of dual compression, reconstruction, tubular, straight "T" and "L" plate configurations. Plates accommodate either standard or locking screws via figure-8 shaped holes.

AI/ML Overview

This document is a 510(k) summary for the Zimmer Universal Locking System: 2.7 mm Locking Plates and Screws. It describes a medical device, its intended use, and its comparison to a predicate device. The review of this document indicates some limitations in providing a comprehensive answer to the detailed questions about acceptance criteria and a study that proves device meets criteria, as the document does not contain that level of detail, especially concerning clinical study methodology, statistical analysis, or ground truth establishment relevant for AI/software-as-a-medical-device (SaMD) evaluations.

Here's a breakdown of the information available and what is not explicitly stated in the provided text:

Key Takeaway: This document is a 510(k) premarket notification for a traditional medical device (bone plates and screws), not a software or AI-driven medical device. Therefore, many of the questions related to AI/SaMD study methodologies (like ground truth, expert consensus, MRMC studies, training/test set sample sizes, data provenance for AI models) do not apply directly to this submission. The "Performance Data" section specifically mentions "Non-Clinical Performance and Conclusions," indicating laboratory testing, not clinical studies in the context of typical AI/SaMD evaluations.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Safety	"found to be safe"
Effectiveness	"found to be effective"
Substantial Equivalence to Predicate Device (K063303)	"The Zimmer Universal Locking System: 2.7mm plates and screws have the same intended use, similar performance characteristics and are similar in design to the predicate devices." (Confirmed by FDA's substantial equivalence determination)
Material Composition	Tivanium® Ti-6Al-4V Alloy, CP Grade Titanium (Implied criterion met by device description)
Intended Use	Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted, Supracondylar, Extra-articular fractures, Fractures in osteopenic bone, Nonunions, Malunions. (Implied criterion met by device description)
Mechanical Performance (Non-Clinical)	"The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." (Specific quantitative performance metrics or acceptance limits are not provided in this summary.)

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not applicable in the context of typical AI/SaMD test sets. The "performance data" refers to non-clinical (laboratory) testing, which would involve a number of physical device samples tested under controlled conditions. The specific number of samples tested is not provided in this summary.
Data Provenance: Not applicable in the context of clinical data for AI/SaMD. The performance data comes from "non-clinical (laboratory) performance testing." The country of origin for this testing is not specified, but the submitter is based in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This question is not applicable to this 510(k) submission. Ground truth established by experts is a concept relevant to the evaluation of AI/software medical devices, which process and interpret data (e.g., images, signals). This device is a physical implant (bone plates and screws). The "ground truth" for its performance would be established through engineering specifications, material science testing, and biomechanical evaluations, not expert clinical consensus on data interpretation.

4. Adjudication Method for the Test Set

This question is not applicable to this 510(k) submission. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data in AI/SaMD studies. The performance assessment here is based on physical/mechanical testing.

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

This question is not applicable to this 510(k) submission. MRMC studies are specific to evaluating the impact of AI in clinical workflows, typically with human readers interpreting cases. This device is a physical implant; it does not involve human readers interpreting data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to this 510(k) submission. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

This question is not directly applicable in the AI/SaMD sense. For a physical device like bone plates and screws, the "ground truth" for its safety and effectiveness is established through:
- Engineering specifications and material properties: Conformance to industry standards, material strength, fatigue life, corrosion resistance, etc.
- Biomechanical testing: Laboratory simulations to demonstrate adequate strength, stiffness, and stability for internal fixation, often comparing against predicate devices or known clinical requirements for bone fixation.
- Clinical experience with predicate devices: The "substantial equivalence" claim relies on the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable to this 510(k) submission. Training sets are used to develop AI/machine learning models. This is a physical device, not an AI model.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable to this 510(k) submission, for the same reasons as (8).

Summary of the Study:

The "study" referenced in this 510(k) summary is non-clinical (laboratory) performance testing. The document states:

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

This testing would have involved evaluating the physical and mechanical properties of the Zimmer® Universal Locking System: 2.7 mm Locking Plates and Screws to ensure they met the required specifications for bone fixation. The safety and effectiveness are also substantiated by demonstrating substantial equivalence to a legally marketed predicate device (Zimmer Universal Locking System, 2.7mm Plates and Screws, K063303). The specific details of these laboratory tests (e.g., types of tests, number of samples, exact methodology, detailed results, specific acceptance criteria beyond "safe and effective") are not provided in this public summary document.

Summary

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083654

Summary of Safety and Effectiveness

Submitter:

Contact Person:

Date:

Trade Name:

Common Name:

Classification Name and Reference:

Predicate Device:

Device Description:

Intended Use:

Zimmer, Inc. FEB 2 6 2009 P.O. Box 708 Warsaw, IN 46581-0708

Anthony Francalancia, RAC Senior Associate, Regulatory Affairs Telephone: (574) 372-4570 Fax: (574) 372-4605

December 5, 2008

Zimmer® Universal Locking System: 2.7 mm Locking Plates and Screws (Tivanium® Ti-6Al-4V Alloy, CP Grade Titanium)

2.7mm TiULS Locking Plate System

Plate, Fixation, Bone (21 CFR § 888.3030) Screw, Fixation, Bone (21 CFR § 888.3040)

Zimmer Universal Locking System, 2.7mm Plates and Screws, manufactured by Zimmer, Inc., K063303, cleared November 22, 2006

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

o Comminuted fractures
Supracondylar fractures o
Extra-articular fractures 0
Fractures in osteopenic bone 0
Nonunions 0
Malunions O

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K083654. 2/2

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

The Zimmer Universal Locking System: 2.7mm plates and screws have the same intended use, similar performance characteristics and are similar in design to the predicate devices.

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 logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2009

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

Re: K083654

Trade/Device Name: Zimmer Universal Locking System: 2.7 mm Locking Plates and Screws (Tivanium Ti-6Al-4V Alloy, CP Grade Titanium)

Regulation Number: 21 CFR 888.3730

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories.

Regulatory Class: II

Product Code: HRS, HWC Dated: February 3, 2009 Received: February 4, 2009

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 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 - Mr. Anthony Francalancia

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 vours.

Mark M. Milliman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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: KO8363636

Zimmer® Universal Locking System: 2.7 mm Locking Plates and Screws (Tivànium® Ti-6Al-4V Alloy, CP Grade Titanium)

Indications for Use:

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

Comminuted fractures o
Supracondylar fractures ಂ
0 Extra-articular fractures
Fractures in osteopenic bone 0
Nonunions 0
Malunions 0

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)

. 2 (Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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019

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.