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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 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.

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.

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.

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