The Zimmer Natural Nail System Cephalomedullary Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps are available to prevent tissue ingrowth into nail threads and increase the length of the nail if desired.

AI/ML Overview

The provided document does not contain information about an AI/ML device, nor does it describe a study involving acceptance criteria or performance metrics in the context of an AI/ML device.

The document is a 510(k) summary for a medical device called the "Zimmer Natural Nail System Cephalomedullary Nails," which is an intramedullary fixation rod for fracture stabilization.

Here's why the requested information cannot be extracted:

No AI/ML Device: The device described is a physical orthopedic implant. There is no mention of artificial intelligence, machine learning, algorithms, image analysis, or any software-based diagnostic or prognostic tool.
Focus on Substantial Equivalence: The 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in the way an AI/ML model would.
Performance Data: The document explicitly states: "Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device." This indicates that clinical studies, which would typically generate the kind of performance data (e.g., accuracy, sensitivity, specificity) relevant to AI/ML device acceptance criteria, were not required or performed for this specific submission. The submission relied on non-clinical (lab) performance testing to show substantial equivalence.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because the provided text pertains to a different type of medical device and regulatory pathway that does not involve AI/ML performance evaluation.

Summary

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K 091566

OCT 2 8 2009

zımmer

Summary of Safety and Effectiveness

Sponsor:	Zimmer, GmbHSulzerAllee 8Winterthur, Switzerland CH-8404
Contact Person:	Daniel J. WillimanSpecialist, Regulatory AffairsTelephone: (574) 371-8065Fax: (574) 372-4605
Date:	May 27, 2009
Trade Name:	Zimmer ® Natural Nail ™ System Cephalomedullary Nails
Common Name:	Intramedullary Fixation Rod
Classification Name and Reference:	Intramedullary fixation rod, product code HSB21 CFR § 888.3020
Predicate Devices:	Zimmer Natural Nail System Piriformis Fossa & Greater Trochanter Antegrade Femoral Nails, manufactured by Zimmer, Inc. (K083497, cleared February 19, 2009)I.T.S.T. ™ Intertrochanteric Subtrochanteric Intramedullary Femoral Nail, manufactured by Zimmer, Inc. (K032367, cleared August 12, 2003)Intramedullary Nail System, manufactured by Zimmer, Inc. (K965098, cleared February 28, 1997)
Device Description:	The Zimmer Natural Nail System Cephalomedullary Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps

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are available to prevent tissue ingrowth into nail threads and increase the length of the nail if desired.

The Zimmer Natural Nail System is intended for Intended Use: bone. include: · Compound and simple shaft fractures · Segmental fractures · Comminuted fractures bone · Pathological fractures · Fractures with bone loss · Pseudoarthrosis, non-union, mal-union and delayed union · Periprosthetic fractures The Zimmer Natural Nail System Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

temporary fracture fixation and stabilization of the

Indications for use of the Cephalomedullary nails

· Proximal, metaphyseal and distal shaft fractures
· Fractures involving osteopenic and osteoporotic
· Surgically created defects such as osteotomies
· Intertrochanteric and subtrochanteric fractures

Cephalomedullary Nails are similar or identical in intended use, materials, sterility, and performance characteristics to the predicate device(s).

Non-Clinical Performance and Conclusions:

The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Zimmer, GmbH % Mr. Daniel J. Williman Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

OCT 2 8 2009

Re: K091566

Trade/Device Name: Zimmer Natural Nail™ System Cephalomedullary Nails Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: October 7, 2009 Received: October 8, 2009

Dear Mr. Williman:

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 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 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. Daniel J. Williman

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,

Mark M. Milburn

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:

Zimmer® Natural Nail™ System Cephalomedullary Nails

Indications for Use:

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.

Indications for use of the Cephalomedullary nails include:

· Compound and simple shaft fractures
· Proximal, metaphyseal and distal shaft fractures
Segmental fractures
Comminuted fractures
· Fractures involving osteopenic and osteoporotic bone
· Pathological fractures
· Fractures with bone loss
· Pseudoarthrosis, non-union, mal-union and delayed union
· Periprosthetic fractures
· Surgically created defects such as osteotomies
· Intertrochanteric and subtrochanteric fractures

Onuta for mxm
(Division Sign)m

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091526

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)

Page 1 of 1

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.