The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine (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 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 from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels.

Additionally, the COUGAR LS Lateral Cage System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be sketally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and may be implanted via an open or a minimally invasive lateral approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When use as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

COUGAR® System:

The COUGAR System is indicated for use as 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). Additionally the COUGAR System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products.

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 tissues, and to restore the height of a collapsed vertebral body. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are 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 these systems are intended for use with DePuy Spine supplemental internal fixation products.

Device Description

The COUGAR and COUGAR LS Lateral Cage Systems consists of PEEK/carbon fiber composite cages (CFRP). Cages are available in parallel or lordotic configurations and are available in various sizes to match patient anatomy. The cage structure is radiolucent with tantalum x-ray markers 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 bone graft material. The COUGAR LS Lateral Cage System may be implanted via an open or a minimally invasive lateral approach. The COUGAR implants are placed via an anterior approach.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of typical medical device performance studies (e.g., accuracy, sensitivity, specificity for diagnostic devices).

Instead, this document is a 510(k) Premarket Notification from the FDA for a COUGAR® LS Lateral Cage System and COUGAR® System, which are intervertebral body fusion devices. The FDA clearance is based on the substantial equivalence of these devices to already legally marketed predicate devices, not on a new clinical study demonstrating specific performance metrics against an acceptance criterion in the way a diagnostic or AI device would be evaluated.

Here's how the provided information relates to your request, highlighting what is not present:

1. A table of acceptance criteria and the reported device performance:

Not present. This type of table is typically found in submissions for devices where performance is measured against quantifiable metrics (e.g., accuracy, sensitivity, specificity, or mechanical robustness thresholds). For this 510(k), the "performance" is primarily assessed through mechanical testing demonstrating equivalence to predicate devices and an analysis of existing clinical literature for similar devices. There are no specific numerical acceptance criteria (e.g., "accuracy > 90%") for this type of implantable device described in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not present. The submission states: "A literature analysis of published clinical data is provided to support the modified Indications for Use." This implies a review of existing clinical studies rather than a new test set explicitly created for this 510(k). Therefore, there's no specific sample size or provenance for a test set as you'd find in an AI/diagnostic study. The data provenance would be from various published clinical studies, not specified here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not present. Since there's no defined "test set" and ground truth establishment in the context of an accuracy study, this information is not applicable and not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not present. As there's no "test set" in the context of an adjudication process, this information is not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not present. This type of study (MRMC, AI assistance) is completely irrelevant to an intervertebral body fusion device and is not mentioned.

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

Not present. This device is an implantable medical device, not an algorithm, so "standalone performance" in that sense is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the indications for use, the "ground truth" regarding the safety and effectiveness of the device (or similar devices) is based on:
- "clinical and radiographic outcomes" reported in "published clinical data" for similar lumbar interbody fusion devices.
- "Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use" compared to predicate devices.
- Mechanical testing (implied by "No additional testing was required as there were no changes to the technological characteristics of the Subject Cage Systems," meaning prior mechanical testing supported the predicate).

8. The sample size for the training set:

Not applicable/Not present. This concept applies to machine learning models. For a physical implantable device, there is no "training set."

9. How the ground truth for the training set was established:

Not applicable/Not present. As above, no training set exists for this device.

Summary of Device Evaluation as per the document:

The device's clearance is based on its substantial equivalence to existing predicate devices.

Key statements from the document regarding "performance" or "proof":

"The technological characteristics of the subject devices remain unchanged from their currently marketed predicate versions in their design, material, performance, and intended use."
"A literature analysis of published clinical data is provided to support the modified Indications for Use. The clinical and radiographic outcomes demonstrate that lumbar interbody fusion devices similar to the COUGAR and COUGAR LS Lateral Cage System are as safe and effective as the predicate devices for the modified Indications for Use."
"No additional testing was required as there were no changes to the technological characteristics of the Subject Cage Systems." (This implies that previous testing on the predicate devices and the unchanged characteristics of the new device are considered sufficient.)
"Based on the technological characteristics, comparison to predicate devices and clinical performance data from the clinical literature, the subject COUGAR and COUGAR LS Lateral Cage Systems are as safe and as effective as the predicate devices due to similar intended use and technological characteristics."

In essence, for this type of device and 510(k) submission, the "proof" is demonstrating that the new device is fundamentally the same (or very similar with no new safety/effectiveness questions) as devices already on the market, backed by existing clinical evidence for that class of devices.

Summary

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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

December 12, 2016

Medos International, Sarl % Mr. Eric Zhu Regulatory Affairs Specialist DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re: K162327

Trade/Device Name: COUGAR® LS Lateral Cage System, COUGAR® System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, MQP Dated: November 9, 2016 Received: November 10, 2016

Dear Mr. Eric Zhu:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162327

Device Name

COUGAR® LS Lateral Cage System and COUGAR® System

Indications for Use (Describe) COUGAR® LS Lateral Cage System:

COUGAR® System:

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the logo for Medos International. The logo consists of a red caduceus symbol on the left, followed by the word "medos" in black, and the word "international" in gray. There is a gray line underneath the words.

510(k) SUMMARY

Submitter Information A.

Manufacturer:	Medos International SárlChemin-Blanc 382400 Le Locle, Switzerland
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Submitter:	DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767
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Contact Person:	Eric Zhu
Address:	325 Paramount Drive
	Raynham, MA 02767
Telephone number:	(508) 828-3730
Fax number:	(508) 828-3269
Email:	Ezhu@its.jnj.com

B. Date Prepared

C. Device Name

Trade/Proprietary Name:	COUGAR® LS Lateral Cage SystemCOUGAR® System
Common/Usual Name:	Intervertebral Body Fusion Device;Spinal Intervertebral Body Fixation Orthosis
Classification and Regulation:	Class II per 21 CFR 888.3080

August 17, 2016

Classification Product and Panel Code:

MAX, MQP; Orthopedic

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Image /page/5/Picture/0 description: The image shows the logo for Medos International. The logo consists of a red caduceus symbol on the left, followed by the word "medos" in black bold font and the word "international" in gray font. A thin gray line runs underneath the text.

D. Predicate Device Name

The subject devices are substantially equivalent to the primary predicate devices cleared under K140759, and the following additional predicate devices: COUGAR® (K081917, K113348), COUGAR® LS Lateral Cage System (K082128, K110454, K122896), Concorde Bullet Lumbar Interbody System (K151773), Medtronic CAPSTONE® Spinal System (K123027) and NuVasive CoRoent® Lumbar System (K151472).

Device Description E.

Indications for Use F.

COUGAR LS Lateral Cage System:

The COUGAR LS Lateral Cage System is indicated for use in the thoracolumbar spine(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 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 from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

Additionally, the Cougar LS Lateral Cage System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and may be implanted via an open or a minimally invasive lateral approach using autogenous bone and/or allogenic bone graft

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s interr

comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, this system is intended for use with DePuy Spine supplemental internal fixation.

COUGAR System:

The COUGAR System is indicated for use as 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). Additionally the COUGAR System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with DePuy Spine supplemental internal fixation products.

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. These systems are also indicated for treating fractures of the thoracic and lumbar spine. These systems are 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 these systems are intended for use with DePuy Spine supplemental internal fixation products.

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

The technological characteristics of the subject devices remain unchanged from their currently marketed predicate versions in their design, material, performance, and intended use.

H. Materials

The materials of the subject devices remain unchanged from the currently marketed predicate devices. Both the COUGAR and COUGAR-LS Lateral Cage implants are manufactured from Carbon Fiber Reinforced PEEK-OPTIMA LT1 Compound (CFRP) with tantalum x-ray markers that conform to ASTM F-560.

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Image /page/7/Picture/0 description: The image shows the logo for Medos International. The word "medos" is in black font, while "international" is in gray font. There is a red medical symbol to the left of the word "medos". A gray line is underneath the entire logo.

I. Performance Data

A literature analysis of published clinical data is provided to support the modified Indications for Use. The clinical and radiographic outcomes demonstrate that lumbar interbody fusion devices similar to the COUGAR and COUGAR LS Lateral Cage System are as safe and effective as the predicate devices for the modified Indications for Use. No additional testing was required as there were no changes to the technological characteristics of the Subject Cage Systems.

J. Conclusion

Based on the technological characteristics, comparison to predicate devices and clinical performance data from the clinical literature, the subject COUGAR and COUGAR LS Lateral Cage Systems are as safe and as effective as the predicate devices due to similar intended use and technological characteristics.

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.