Search Results

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® rTLIF is a collection of additively manufactured spacers for lumbar/lumbosacral 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® open devices incorporate a large vertical cavity which can be packed with autograft or allograft comprised of cancellous and/or corticocancellous 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.

The provided text is a 510(k) summary for a medical device (Nexxt Matrixx® System) and does not describe a study involving an AI or software-based medical device. Therefore, I cannot extract the information required to answer your prompt.

The document discusses a physical interbody fusion device and its substantial equivalence to a predicate device based primarily on mechanical performance testing (finite element analyses and Dynamic Axial Compression per ASTM F2077). It does not mention any artificial intelligence (AI) or machine learning components, nor does it describe a study involving human readers or the establishment of ground truth for a test set in the context of an AI device.

Therefore, I cannot populate the requested information.

Ask a specific question about this device