The Cougar® LS Lateral Cage System is indicated for use in the thoracolumbar spine (i.e., T1 to 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. This system is also indicated for treating fractures of the thoracic and lumbar spine. The 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, this system is intended for use with DePuy Spine supplemental internal fixation.

The Cougar® LS Lateral Cage System is also indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

Device Description

The Cougar® LS Lateral System implants are manufactured from Carbon Fiber Reinforced Polymer (CFRP) material. Cages are available with 15° lordotic configurations, widths of 18mm and 21mm, and heights ranging from 10mm to 20mm in 2mm increments. The cages' lengths are 45mm, 50mm, 55mm, and 60mm.

The cage structure is radiolucent with tantalum X-ray wire so that healing can be assessed by normal radiographic methods. The cages have teeth that resist rotation and migration and have cavities to accept packing of autogenous bone graft.

The implants may be utilized in either an open or minimally invasive surgical approach. The implants are placed using a lateral surgical approach.

AI/ML Overview

The provided text describes a 510(k) summary for the Cougar® LS Lateral Cage System, a medical device. This document does not describe acceptance criteria or a study that proves the device meets acceptance criteria in the typical sense of a clinical or performance study with defined metrics like sensitivity, specificity, accuracy, etc., which are common for AI/software devices.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical medical implant. The "acceptance criteria" here are implicitly tied to the performance standards set by the predicate devices and general consensus standards for spinal implants. The "study" refers to bench testing to show the device meets these physical and mechanical performance characteristics.

Here’s a breakdown based on your request, interpreting "acceptance criteria" and "study" within the context of this 510(k) submission for a physical implant:

Acceptance Criteria and Device Performance for Cougar® LS Lateral Cage System

The acceptance criteria for this device are implicitly derived from the performance of its predicate devices (DePuy Spine Cougar® LS Lateral Cage System, K082128, K110454) and compliance with recognized ASTM standards for spinal implants. The "study" conducted was mechanical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Strength	ASTM F2077-11 (Static & Dynamic Compression)	Device must withstand specified static and dynamic compression loads without failure, comparable to predicate device performance.	Testing was submitted to characterize the subject implants. Implies successful completion meeting performance requirements.
Mechanical Strength	ASTM F2077-11 (Static & Dynamic Compressive Shear)	Device must withstand specified static and dynamic compressive shear loads without failure, comparable to predicate device performance.	Testing was submitted to characterize the subject implants. Implies successful completion meeting performance requirements.
Expulsion Resistance	ASTM F2267-04 (Expulsion Testing)	Device must resist expulsion under specified forces, comparable to predicate device performance.	Testing was submitted to characterize the subject implants. Implies successful completion meeting performance requirements.
Subsidence Resistance	ASTM F2267-04 (Subsidence Testing)	Device must demonstrate acceptable resistance to subsidence under specified loads, comparable to predicate device performance.	Testing was submitted to characterize the subject implants. Implies successful completion meeting performance requirements.
Material Equivalence	Carbon Fiber Reinforced Polymer (CFRP) / PEEK	Material properties must be equivalent or superior to predicate device materials.	The proposed cages are manufactured from Carbon Fiber Filled PEEK-OPTIMA LT1 Compound (CFRP), which is identical to the predicate system's materials.
Similar Performance	Overall Biomechanical Integrity & Functionality	The device, despite increased lordotic angle, must provide the same strength and performance as the predicate devices.	"The increase in lordotic angle provides the same strength and performance as 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 (number of units) used for each mechanical test (e.g., number of cages subjected to compression testing). For bench testing of medical devices, it typically involves a set number of units per test condition to achieve statistical significance or meet standard requirements.
Data Provenance: The data provenance is from mechanical bench testing conducted by the manufacturer, Medos International Sárl / DePuy Spine, Inc. This is prospective testing specifically performed for this 510(k) submission. No country of origin for the data is explicitly mentioned beyond the manufacturer's location in Switzerland and the submitter's location in the USA.

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

This type of information (number and qualifications of experts for ground truth) is not applicable to this submission. The "ground truth" for mechanical testing is established by the specified ASTM standards and the physical laws governing material science and biomechanics, not by expert human consensus. The data is generated by testing equipment, and the interpretation of compliance is typically done by engineers and regulatory specialists.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing does not involve human adjudication in the way clinical studies or expert review of images would. The results are quantitative measurements against predefined criteria in the ASTM standards.

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 imaging devices or software where human readers interpret output; it is not applicable to a physical spinal implant.

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

No, a standalone "algorithm only" performance study was not done. This term is only relevant for AI/software devices.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment is based on established mechanical performance standards (ASTM F2077-11, ASTM F2267-04) and the demonstrated performance of legally marketed predicate devices. The goal is to show that the modified device performs equivalently to these benchmarks.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of mechanical bench testing for a physical implant. Training sets are relevant for machine learning algorithms.

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

This is not applicable for the reasons stated above.

Summary

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长122896 page 1 of 3

510(K) SUMMARY

OCT 18 2012

A.	Submitter Information
	Manufacturer:	Medos International Sárl
		Chemin-Blanc 38
		2400 Le Locle, Switzerland
	Submitter:	DePuy Spine, Inc.
		325 Paramount Drive
		Raynham, MA 02767
	Contact Person:	Kirsten Lehmuller
		325 Paramount Drive
		Raynham, MA 02767
	Telephone number:	508-828-3291
	Fax number:	508-828-3797
	Email:	klehmull@its.jnj.com
B.	Date Prepared	September 20, 2012
C.	Device Name
	Trade/Proprietary Name:	Cougar® LS Lateral Cage System
	Common/Usual Name:	Spinal Intervertebral Body Fixation Orthosis,Intervertebral body fusion device
	Classification Name:	Spinal Intervertebral Body Fixation Orthosisper 21 CFR §888.3060Intervertebral body fusion deviceper 21 CFR §888.3080

D. Predicate Device Name

Trade name: DePuy Spine Cougar® LS Lateral Cage System (K082128, K110454)

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E. Device Description

The implants may be utilized in either an open or minimally invasive surgical approach. The implants are placed using a lateral surgical approach.

F. Intended Use

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months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

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

The proposed modification to the DePuy Cougar LS Lateral System (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 LS devices. The increase in lordotic angle provides the same strength and performance as the predicate devices. The materials and technology remain identical to the predicate system.

Materials G.

The proposed cages are manufactured from Carbon Fiber Filled PEEK-OPTIMA LT1 Compound (CFRP).

H. Performance Data

Performance data per ASTM F2077-11 and ASTM F2267-04 was submitted to characterize the subject Cougar LS Lateral Cage implants addressed in this notification. This testing was comprised of static and dynamic compression, static and dynamic compressive shear, expulsion, and subsidence testing on the proposed device.

l. Conclusion

Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.

Public Health Service

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

Medos International Sárl % Depuy Spine, a Johnson and Johnson Company Ms. Kristen Lehmuller Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

OCT 1 8 2012

Re: K122896

Trade/Device Name: Cougar® LS Lateral Cage Implants Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: September 20, 2012 Received: September 21, 2012

Dear Ms. Lehmuller:

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

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Page 2 - Ms. Kristen Lehmuller

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 yours,

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 STATEMENT

510(k) Number (if known): ≤ (22796

Device Name: Cougar® LS Lateral Cage Implants

Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(21 CFR 801 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 of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122896

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.