The COUGAR System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via anterior (COUGAR) approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with DePuy Spine supplemental internal fixation.

The COUGAR System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The COUGAR System is also indicated for treating fractures of the thoracic and lumbar spine. The COUGAR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. When used as a vertebral body replacement device, the COUGAR System is intended for use with DePuy Spine supplemental internal fixation.

Device Description

The Cougar® System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of autogenous bone graft materials.

AI/ML Overview

Here's an analysis of the provided text regarding the Cougar® Implant System, focusing on acceptance criteria and the supporting study:

The provided document is a 510(k) Summary for the DePuy Spine Cougar® Implant System, specifically for a modification (increase in lordotic angle) to an existing device. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria for a novel device or AI performance. Therefore, many of the requested points related to AI/algorithm performance, ground truth, and expert adjudication are not applicable to this document.

Understanding the Context:

This is a regulatory submission for a medical device. The "acceptance criteria" here refer to demonstrating that the modified device (with increased lordotic angle) is as safe and effective as previously cleared predicate devices. The "study" is a series of performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a physical medical device (spinal implant) and not an AI/software device, the "acceptance criteria" are related to mechanical and material performance. The document doesn't explicitly state numerical acceptance criteria, but rather implies meeting the performance established by the predicate devices through standardized testing.

Acceptance Criteria (Implied)	Reported Device Performance
Maintain strength and performance comparable to predicate devices	Passed static and dynamic compression testing per ASTM standards
Maintain open architecture for bone graft materials	Consistent with predicate design
Utilize carbon-fiber reinforced PEEK Optima material	Identical to predicate device material
Demonstrate no new questions of safety and effectiveness	Data presented demonstrates safety and effectiveness
Maintain intended use (spinal fusion, vertebral body replacement)	Intended use remains unchanged

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

The document describes performance testing of the physical implant, not a "test set" in the context of AI models evaluating data.

Sample Size: The document does not specify the exact number of implants or test specimens used for the performance tests (static compression, dynamic compression, subsidence, expulsion). It simply states "This testing was comprised of static and dynamic compression testing on the proposed device as well as subsidence and expulsion testing."
Data Provenance: Not applicable in the context of an AI model's data. This is laboratory-based mechanical testing of manufactured devices.
Retrospective or Prospective: Not applicable. These are physical tests conducted on manufactured prototypes or samples.

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

Not applicable. There is no concept of "ground truth" established by human experts for mechanical performance testing of a physical implant. The "ground truth" for mechanical testing is typically defined by engineering specifications and material properties, validated by standardized tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in human expert interpretations of data, particularly in medical image analysis or clinical diagnosis. This is not relevant for mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies are used to compare the diagnostic performance of different readers or systems (often involving AI) on multiple cases. This document concerns the mechanical safety and efficacy of a spinal implant, not diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical implant, not a software algorithm or AI.

7. Type of Ground Truth Used

For the performance testing mentioned:

Type of Ground Truth: The "ground truth" for physical device performance is based on established engineering standards and material science principles, verified through standardized mechanical and material tests. The relevant ASTM standards are cited (ASTM F2077-11, ASTM-F2267-04), which define how such tests should be conducted and how performance characteristics are measured. The "ground truth" is that the device, when subjected to these tests, performs within acceptable parameters (usually implied to be similar to or better than the predicate devices).

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study. There is no "training set."

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

Not applicable. There is no "training set" or "ground truth" in the AI/ML sense for this type of device submission.

Summary

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DEC 1 3 2011

510(K) SUMMARY

Submitter Information A.

	DePuy Spine, Inc.
	325 Paramount Drive
	Raynham, MA 02767

Contact Person:	Kevin G. Stevens
Address:	325 Paramount Drive
	Raynham, MA 02767
Telephone number:	508-977-6445
Fax number:	508-828-3797
Email:	ksteven1@its.jnj.com
Date Prepared	November 11, 2011
Device Name
Trade/Proprietary Name:	Cougar® Implant System
Classification Name:	Spinal Vertebral Body Replacement Device 21 CFR 888.3060, Orthosis, Spinal Intervertebral Fusion 21 CFR 888.3080

Predicate Device Name D.

DePuy Spine Cougar® System (K081917) Trade name: DePuy Spine X-Mesh System (K080568) DePuy Spine Leopard® System (K031635) DePuy Spine Cougar LS Lateral Cage® System (K110454) DePuy Spine Concorde Curve® System (K101923)

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Device Description E.

The Cougar® System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of autogenous bone graft materials.

Intended Use F.

Summary of Similarities and Differences in Technological Characteristics, G. Performance and Intended Use

The proposed modification to the DePuy Cougar® Implant (i.e. increase in lordotic angle) results in a device that is substantially equivalent to the predicates. The footprint of the subject devices remains unchanged from the predicate Cougar devices. The increase in lordotic angle provides the same

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strength and performance as the predicate devices. The materials, and technology remain identical to the predicate system.

H.. Materials

The proposed cages are manufactured from carbon-fiber reinforced PEEK Optima material. This material is identical to the predicate devices.

Performance Data l.

Performance data per ASTM F2077-11, ASTM-F2267-04, and DePuy Spine internal protocols were submitted to characterize the subject Cougar® Implants that are the subject of this PreMarket notification. This testing was comprised of static and dynamic compression testing on the proposed device as well as subsidence and expulsion testing.

J. Conclusion

DePuy Spine provided Performance Testing to demonstrate that the increase in lordotic angle (1) does not change the intended use of the device and (2) the change in scientific technology (i.e. change in lordotic angle) does not raise new questions of safety and effectiveness. The data presented in this PreMarket Notification demonstrates that the subject devices are as safe and effective as the chosen predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

DEC 1 3 2011

DePuy Spine, Inc. % Mr. Kevin G. Stevens 325 Paramount Drive Raynham. Massachusetts 02767

Re: K113348

Trade/Device Name: Cougar® Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MOP Dated: November 11, 2011 Received: November 14, 2011

Dear Mr. Stevens:

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. 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

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Page 2 – Mr. Kevin G. Stevens

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.

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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov//MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Eunice Keith

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: COUGAR™ System

Indications For Use:

Prescription Use ______________ AND/OR Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(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)

(Division Sign-Off)

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

· K113348 510(k) Number_

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.