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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.

The COUGAR® LS Lateral Cage System consists of the 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 proposed devices in this submission include cages with smaller height dimensions (6-10 mm) to meet customer demand.

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. The implants are manufactured from PEEK Optima material.

This document is a 510(k) summary for the Cougar® LS Lateral Cage System, which is a medical device. The information provided relates to the device itself and its performance characteristics (mechanical strength, material properties) rather than an AI/ML software device.

Therefore, the requested information (acceptance criteria and study details for an AI/ML device, including sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or available in the provided text.

The closest relevant section is "I. Performance Data", which states:
"Performance data per ASTM F2077 were submitted to characterize the subject Cougar® LS Lateral Cage Implants addressed in this notification. This testing was comprised of static and dynamic compression testing on the proposed device."

This indicates that mechanical testing was performed to demonstrate that the device meets certain physical performance standards (likely strength, durability, etc.) as defined by ASTM F2077. However, these are not "acceptance criteria" in the context of AI/ML performance metrics (e.g., sensitivity, specificity) and there is no mention of a study involving AI/ML.

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