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

The Tivanium 3.5mm locking screws are used to engage the proximal locking screw holes within the NCB Polyaxial Locking Plate System, Proximal Humeral Plates.

AI/ML Overview

This document describes the Zimmer NCB® Polyaxial Locking Plate System and Zimmer® Universal Locking System with 3.5mm Tivanium® Ti-6Al-4V Alloy Locking Screws. It's a 510(k) premarket notification for a Class II medical device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (bone fixation plates and screws), the "acceptance criteria" are primarily related to safety, effectiveness, and substantial equivalence to predicate devices, rather than specific performance metrics like accuracy, sensitivity, or specificity commonly seen in diagnostic AI/software devices. The performance is assessed through non-clinical (laboratory/performance) testing.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Intended Use	Same as predicate device	NCB Polyaxial Locking Plate System: Indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. Tivanium 3.5mm Locking Screws: Intended to be used with the NCB Polyaxial Locking Plate System. (Matches predicate's intended use)
Performance Characteristics	Similar to predicate device	Non-clinical (Laboratory / performance) testing demonstrated that the device is safe and effective. (Implies performance is comparable to predicate, meeting safety and effectiveness standards)
Design	Similar to predicate device	NCB plates are similar in design to the predicate device. Universal Locking System screws have similar design characteristics.
Materials	Similar to predicate device (or justified difference)	NCB plates are similar in materials to the predicate device. The proposed Universal Locking System screws are made from Tivanium (Ti-6Al-4V) alloy versus the Stainless Steel of the predicate device. (This difference was likely justified through non-clinical testing showing equivalence or superiority in relevant properties).
Safety and Effectiveness	Device is safe and effective	Non-clinical (Laboratory / performance) testing demonstrated that the device is safe and effective.

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

This device is a hardware implant (plates and screws for bone fixation). The performance testing described is non-clinical (laboratory/performance) testing, not clinical trials involving human subjects or data sets in the way AI/software devices are typically evaluated.

Sample size for the test set: Not applicable in the context of clinical data. The document does not specify sample sizes for mechanical or laboratory tests, which would typically involve testing a certain number of devices or components under simulated conditions.
Data provenance: Not applicable. The "data" comes from laboratory and performance testing, not human-derived data like images or patient records.

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

Not applicable. Ground truth for clinical data is not relevant here as the evaluation relies on non-clinical, laboratory performance testing of the hardware. The "ground truth" for such devices is established through engineering standards, biomechanical principles, and documented performance of predicate devices.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for clinical data interpretation (e.g., in diagnostic studies) where human experts might disagree. This device was evaluated through non-clinical laboratory testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess the impact of AI on human reader performance. This document pertains to a bone fixation hardware device, for which MRMC studies are not applicable.

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

No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on engineering specifications, biomechanical testing standards, and performance characteristics established for bone fixation devices. It relies on laboratory test results demonstrating mechanical strength, fatigue resistance, biocompatibility (often implicitly covered by material commonality), and other physical properties under simulated conditions.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware product, not a machine learning model. There is no "training set" in this context.

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

Not applicable, as there is no training set.

Summary

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K081759 #'

zımımer

OCT 1 6 2008

Summary of Safety and Effectiveness
Sponsor:	Zimmer, GmbHSulzer Allee 8Winterthur, Switzerland CH-8404
Contact Person:	Eric S. PittmanAssociate, Regulatory AffairsTelephone: (574) 371-8369Fax: (574) 372-4605
Date:	06/20/2008
Trade Name:	NCB® Polyaxial Locking Plate System; ProximalHumeral Plates and Zimmer® Universal LockingSystem; 3.5mm Tivanium® Ti-6Al-4V AlloyLocking Screws
Common Name:	Plating System
Classification Nameand Reference:	Plate, Fixation, Bone (21 CFR § 888.3030)Screw, Fixation, Bone (21 CFR § 888.3040)
Predicate Device:	NCB Plating System, manufactured by ZimmerGmbH, K042695, cleared October 29, 2004
	Zimmer® Universal Locking System, manufacturedby Zimmer Inc., K060710, cleared April 26, 2006
Device Description:	The NCB Polyaxial Locking Plate System is anextramedullary internal fixation plate system to beused for proximal humeral fractures. It is intendedto be implanted either percutaneously or by atraditional open method.
	The Tivanium 3.5mm locking screws are used toengage the proximal locking screw holes within theNCB Polyaxial Locking Plate System, ProximalHumeral Plates.

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K081759 #2/2

Intended Use:

Comparison to Predicate Device:

Performance Data (Non-clinical and/or Clinical):

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

The Tivanium 3.5mm Locking Screws are intended to be used with the NCB Polyaxial Locking Plate System.

The NCB plates have the same intended use, similar performance characteristics and are similar in design and materials to the predicate device.

The Universal Locking System screws have the same intended use, similar performance and design characteristics. The proposed device is made from Tivanium (Ti-6Al-4V) alloy versus the Stainless Steel of the predicate device.

Non-Clinical Performance and Conclusions:

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

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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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 stylized eagle with three stripes forming its body and wing. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2008

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

Re: K081759 Trade/Device Name: NCB® Polyaxial Locking Plate System, Proximal Humeral Plates and Zimmer® Universal Locking System; 3.5mm Tivanium® Ti-6A1-4V Alloy Locking Screws 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: September 19, 2008 Received: September 22, 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. Iisting 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

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Page 2 - Mr. Anthony Francalancia, RAC

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.

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 N. Mulkeen

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): KO81759

Device Name:

NCB® Polyaxial Locking Plate System, Proximal Humeral Plates Zimmer® Universal Locking System, 3.5mm Tivanium Ti-6AL-4V Alloy Screws

Indications for Use:

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

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)

Neil R. Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number	K081759

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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.