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The Stryker Spine Tritanium® TL cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium TL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium TL Cage is to be implanted via a posterior approach.

The Tritanium TL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The purpose of this submission is to introduce a curved posterior lumbar cage intended for use as an aid in lumbar spinal fixation.

The Tritanium TL Intervertebral Body Fusion Cage is intended for use as an aid in lumbar spinal fixation. The cage is a curved implant that consists of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The cage is offered in a variety of lengths, heights and lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior surfaces designed for multidirectional fixation and to maximize surface area for endplate contact with the implant. The implants have a smooth, tapered leading edge to facilitate cage insertion into the intervertebral space. The implants have a central column spanning endplate to endplate for graft containment and to aid in fusion throughout the interbody cage.

The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine.

The Tritanium TL cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08) and are provided sterile.

The provided document is a 510(k) summary for the Stryker Tritanium® TL Curved Posterior Lumbar Cage, an intervertebral body fusion device. It details the device's characteristics and the testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not describe the acceptance criteria, reported device performance, or details of a study on AI/algorithm performance for a medical imaging or diagnostic device.

The request asks for information relevant to AI-powered medical devices, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, and standalone performance. None of this information is present in the provided text, as the document pertains to a physical orthopedic implant, not a software-based diagnostic tool.

Therefore, I cannot fulfill the request for information related to acceptance criteria and device performance in the context of AI/algorithm studies based on the provided text. The document describes mechanical and material testing for a physical implant, not an algorithm's performance.

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