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The Stand-Alone ALIF Tianium System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to allow packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion.

The Stand-Alone ALIF Titanium System is intended for use with three titanium alloy screws which are provided with the system. If the physician chooses to use fewer than three of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used. When used with Barbs (Anchors), these devices are intended for use with supplemental fixation (e.g. Pedicle screws or posterior fixation).

The Stand-Alone ALIF Titanium System implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Titanium Alloy (Ti-6Al-4V ELI per ASTM F136). The spacers are hollow to permit packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/ or migration. The anterior face of the spacer has integrated screw holes to allow for placement of three titanium alloy screws that anchor the implant to the adjacent vertebrae. Additionally, the barbs may be inserted through the screw holes in place of screws. The barbs are intended to provide additional stability to the cage but require supplementary fixation, such as pedicle screws. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Stand-Alone ALIF Titanium System components with components from any other system or manufacturer. The components should never be reused under any circumstances.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Stand-Alone ALIF Titanium System." It primarily describes the device's intended use, materials, and substantial equivalence to previously cleared devices. It does not present information about an AI/ML-driven device, nor does it contain a study proving the device meets acceptance criteria related to AI/ML performance.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's questions pertain specifically to the acceptance criteria and study proving performance for an AI/ML-based medical device.

This document is about a spinal implant (an intervertebral body fusion device), not an artificial intelligence or machine learning product. It discusses mechanical performance testing (ASTM F2077-14 for static and dynamic compression/shear) to demonstrate substantial equivalency to predicate devices, which is a different type of performance evaluation than what would be done for an AI/ML device.

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