The NCB Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including:

Periprosthetic fractures
Comminuted fractures
Fractures in osteopenic bone
Nonunions
Malunions

Device Description

The NCB Straight Narrow Shaft Plates are a line of polyaxial locking plates for the treatment of humeral and tibial shaft fractures, including periprosthetic fractures. The NCB System technology allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the plate holes. In the locked mode the NCB Straight Narrow Shaft Plate acts as an internal fixator without contact between the plate and the bone surface, reducing the risk of periosteal blood supply impairment. This Non-Contact-Bridging concept can be specifically controlled through the use of 1, 2, or 3mm spacers, which are threaded into the plate holes prior to plate insertion. Plates, screws, blind screw inserts, spacers and locking caps are made of titanium alloy.

AI/ML Overview

The provided document is a 510(k) summary for the Zimmer NCB Straight Narrow Shaft Plates, which are medical devices for internal bone fixation. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance testing and comparison to predicate devices, rather than clinical studies with human readers or AI.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a medical device for bone fixation, and the "acceptance criteria" are related to mechanical performance and substantial equivalence to existing devices. The document does not explicitly state acceptance criteria in a quantifiable table format, but rather describes the types of tests performed and the conclusion that the device performs similarly to predicates.

Acceptance Criteria (Implied)	Reported Device Performance and Conclusions
Mechanical Properties (Stiffness, Fatigue Strength)	Engineering analysis and comparative fatigue testing of the NCB Straight Narrow Shaft Plate against the Synthes 4.5 mm Locking Compression Plates (predicate devices) "resulted in very similar mechanical properties of both devices." Plate testing/analyses included: plate stiffness (bending and torsion), plate fatigue strength, screw/plate construct strength, construct strength with compatible cables and Cable Button, and compression slot resistance to screw pull-through.
Safety and Effectiveness	Results of non-clinical (lab) performance testing "demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices."
Suitability for Use in Osteopenic Bone	A literature review was conducted and concludes that the proposed device is suitable for use in osteopenic bone.
Substantial Equivalence (Intended Use, Materials, etc.)	The NCB Straight Narrow Shaft Plates are "similar in intended use, materials, sterility, and performance characteristics to the predicate devices."

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

Sample Size for Test Set: The document does not specify exact "sample sizes" for the mechanical tests (e.g., number of plates tested for fatigue). It mentions "comparative fatigue testing" and "plate testing/analyses," but not the quantity of items tested.
Data Provenance: The tests are described as "non-clinical (lab) performance testing," indicating they were conducted in a laboratory setting. There is no mention of country of origin for the data beyond the manufacturer being Zimmer GmbH in Switzerland, and the FDA review being in the US. The data is prospective in the sense that the tests were performed specifically for this submission.

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

This question is not applicable in the context of this device and submission. "Ground truth" established by experts typically pertains to diagnostic accuracy studies (e.g., radiologists interpreting images) for AI or diagnostic devices. For mechanical fixation devices like the NCB Straight Narrow Shaft Plates, the "ground truth" is based on established engineering principles, material science, and biomechanical testing standards, not expert interpretation of results in the same way. The "experts" involved would be those conducting the engineering analysis and testing, but their number and specific qualifications are not detailed in this type of submission summary.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where human disagreement on "ground truth" (e.g., disease presence in an image) needs to be resolved. For mechanical testing, the results are typically quantitative and objective, following established protocols, and do not involve human adjudication in this sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is for evaluating diagnostic accuracy, often comparing human performance with and without AI assistance. This document describes a medical device for bone fixation, and its performance evaluation is mechanical. It does not involve human "readers" or AI assistance for diagnostic tasks.

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

No. This question is relevant for AI algorithms. The device described here is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of this device is derived from:

Established engineering and biomechanical principles: For tests like stiffness, fatigue strength, and construct strength.
Material science standards: For evaluating the titanium alloy.
Literature review: To substantiate the use in osteopenic bone, indicating reference to existing scientific knowledge and clinical outcomes data from similar devices/materials.
Comparative data: The device's performance is compared directly to predicate devices, where the predicate devices' established performance serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. "Training set" refers to data used to train an AI algorithm. This device is a physical implant and does not involve AI.

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

This question is not applicable for the same reason as above.

Summary

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K113718 #1/2

Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a circle with the letter Z inside of it. Below the circle is the word "zimmer" in a stylized font.

JAN 2 7 20:12 P.O. Box 708 Warsaw. IN 46581-0708 574 267-6131

510(k) Summary

Zimmer. GmbH

SulzerAllee 8

Sponsor:

Contact Person:

Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 371-8760

December 16, 2011

NCB® Straight Narrow Shaft Plates

Winterthur, Switzerland CH-8404

Locking Plate System

Plate, Fixation, Bone (21 CFR 888.3030)

4.5mm Locking Compression Plate (LCP) System with Expanded Indications, manufactured by Synthes, K082807, cleared January 13, 2009, and NCB Periprosthetic Femur Polyaxial Locking Plate System, manufactured by Zimmer, K100111, cleared April 12, 2010.

Date:

Trade Name:

Common Name:

Classification Names and References:

Predicate Devices:

Device Description:

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K11378 #212

Intended Use:	The NCB Straight Narrow Shaft Plate is indicated fortemporary internal fixation and stabilization of humeral andtibial fractures and osteotomies, including:
	Periprosthetic fractures Comminuted fractures Fractures in osteopenic bone Nonunions Malunions
Comparison to Predicate Device:	The NCB Straight Narrow Shaft Plates are similar inintended use, materials, sterility, and performancecharacteristics to the predicate devices.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:
	The results of non-clinical (lab) performance testingdemonstrate that the devices are safe and effective andsubstantially equivalent to the predicate devices.
	Engineering analysis as well as results of comparativefatigue testing of the NCB Straight Narrow Shaft Plate andSynthes 4.5 mm Locking Compression Plates (predicatedevices) resulted in very similar mechanical properties ofboth devices.
	Plate testing/analyses performed included; plate stiffness(bending and torsion), plate fatigue strength, screw/plateconstruct strength, construct strength with the compatiblecables and Cable Button and compression slot resistance toscrew pull-through.
	A literature review was conducted to substantiate the use ofthe proposed device in osteopenic bone.
	Clinical Performance and Conclusions:
	Clinical data and conclusions were not needed for thisdevice.

Intended

The NCB Straight Narrow Shaft Plate is indicated for
temporary internal fixation and stabilization of humeral and
tibial fractures and osteotomies, including:

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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 curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

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

Zimmer GMBH % Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

JAN 2-7 2012

Re: K113718

Trade/Device Name: NCB® Straight Narrow Shaft Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II

Product Code: HRS, HWC Dated: December 16, 2011 Received: December 19, 2011

Dear Mr. McKelvey:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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Page 2 -- Mr. Stephen H. McKelvey

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 yours,

ely yours,

N. Melkerson

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

KI13718 510(k) Number (if known):

Device Name:

NCB® Straight Narrow Shaft Plate

Indications for Use:

The NCB Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including:

· Periprosthetic fractures
· Comminuted 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)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ja. N. Shup

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

510(k) Number K113718

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.