The NCB Plating System is an extramedullary internal fixation plate system to be used for proximal tibia fractures. It is intended to be implanted either percutaneously or by a traditional open method.

AI/ML Overview

Here's an analysis of the provided document regarding the acceptance criteria and study for the Zimmer NCB® Plating System:

This document is a 510(k) premarket notification for a medical device (a bone plate system), which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical trial data with specific acceptance criteria and detailed performance metrics as one might find for a novel drug or a high-risk AI-powered diagnostic device.

Therefore, many of the requested data points (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable or not provided in this type of submission. The safety and effectiveness are established primarily through non-clinical performance testing and comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Predicate Comparison & Non-Clinical Testing)	Reported Device Performance
Mechanical Performance: Equivalent or superior to predicate devices for intended use (temporary internal fixation and stabilization of fractures and osteotomies of long bones). This would typically involve criteria for strength, fatigue life, and torsional rigidity appropriate for bone fixation.	"The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." "The NCB Plating System Proximal Tibia plates have the same intended use, similar performance characteristics, are made of the same material and are similar in design to the predicate devices."
Material Properties: Made of the same material as predicate devices.	"Made of the same material" as predicate devices.
Biocompatibility: (Implied, as it's a bone implant)	Not explicitly detailed, but implied by regulatory compliance and use of approved materials.
Design: Similar in design to predicate devices.	"Similar in design to the predicate devices."
Intended Use: Consistent with predicate devices.	"The NCB Plating System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones," which is "the same intended use" as the predicate devices.

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

Not applicable/Not provided for clinical data.
The document refers to "non-clinical (laboratory) performance testing." For such testing, sample sizes would refer to the number of test articles (e.g., bone plates) evaluated. This information is typically detailed in the test reports themselves, which are referenced in the submission but not included in this summary. The data provenance is from laboratory testing (likely internal or contract labs) supporting the submitter (Zimmer, Inc.).

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

Not applicable.
This device relies on non-clinical performance data and substantial equivalence to predicate devices, not on expert-adjudicated clinical test sets for ground truth.

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

Not applicable.
No clinical test set requiring expert adjudication 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 a mechanical bone plating system, not an AI-powered diagnostic device, so MRMC studies involving human readers and AI are irrelevant.

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

Not applicable.
This is a mechanical device, not an algorithm.

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

For the "non-clinical (laboratory) performance testing," the "ground truth" would be established by physical measurements, mechanical engineering standards, and performance specifications derived from regulatory requirements and comparisons to predicate device performance. For instance, the "truth" for a fatigue test is whether the device withstands a specified number of cycles without failure.

8. The sample size for the training set

Not applicable.
There is no "training set" in the context of this mechanical device submission.

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

Not applicable.
There is no "training set" or corresponding ground truth establishment described for this mechanical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 text is in a bold, sans-serif font.

Kobizil

Summary of Safety and Effectiveness

JUN 1 4 2006

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Anthony FrancalanciaSenior Associate, Regulatory AffairsTelephone: (574) 372-4570Fax: (574) 372-4605
Date:	April 28, 2006
Trade Name:	NCB® Plating System
Common Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Classification Reference:	21 CFR § 888.3030, 3040
Predicate Devices:	Zimmer NCB® Plating System, Humerus andFemur Plates (K042695, cleared October 29, 2004).Synthes 4.5mm Titanium LCP Proximal TibiaPlating System (K023802, cleared January 28.2003).Synthes 3.5mm Titanium LCP Proximal TibiaPlating System (K030597, cleared March 20, 2003).
Device Description:	The NCB Plating System is an extramedullaryinternal fixation plate system to be used forproximal tibia fractures. It is intended to beimplanted either percutaneously or by a traditionalopen method.
Intended Use:	The NCB Plating System is indicated for temporaryinternal fixation and stabilization of fractures andosteotomies of long bones.
Comparison to Predicate Device:	The NCB Plating System Proximal Tibia plateshave the same intended use, similar performancecharacteristics, are made of the same material andare similar in design to the predicate devices.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a circle with a stylized letter "Z" inside of it. To the right of the circle is the word "zimmer" in lowercase letters. The font is bold and sans-serif.

Performance Data (Non-clinical):

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

{2}------------------------------------------------

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

APR 1 3 2012

Re: K061211 Trade/Device Name: NCB® Plating System 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: April 28, 2006 Received: May 1. 2006

Dear Mr. Francalancia:

This letter corrects our substantially equivalent letter of June 14, 2006.

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 (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 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

{3}------------------------------------------------

Page 2 - Mr. Anthony Francalancia

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark A. Wilkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): KXQ | 2 | |

Device Name:

NCB® Plating System

Indications for Use:

The NCB Plating System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.

Prescription Use _X (Part 2) 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)

D. O'Dell

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K061211

Page I of I

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.