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When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of nonoperative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.

The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7µm). The intervening geometric lattices have pores 300-700µm. The inferior/superior aspects of the NEXXT MATRIXX® ALIF and Lateral devices incorporate a large vertical cavity which can be packed with bone graft material. The devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.

This appears to be an FDA 510(k) summary for a medical device called the "NEXXT MATRIXX® System," which is an intervertebral body fusion device. The document describes the device, its intended use, and the basis for its substantial equivalence to previously marketed devices.

However, the provided text does not contain information about a study that proves the device meets specific acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning algorithm. The "Performance Data" section indicates: "The modified devices were evaluated via dimensional analyses. The results demonstrated the performance of the modified ALIF and Lateral interbody devices to substantially equivalent to the predicate." This refers to physical and mechanical characteristics of the implant, not the performance of an AI system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI device meets those criteria based on this document. The document pertains to a physical medical device (spinal implant), not an AI algorithm.

If you have a different document or would like to ask about other aspects of AI device approval, please provide the relevant information.

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