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The Camber Spine Alcantara Thoracolumbar Plate System 2, 3 and 4-screw plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative Disc Disease (defined as back pain of discogenic origin with deqeneration of the disc confirmed by patient history and radioaraphic studies): Pseudoarthrosis: Spondylolisthesis: Spinal stenosis: Tumors; Trauma (i.e. Fractures including dislocation and subluxation) Deformities (i.e. Scoliosis, Kyphosis or Lordosis); Failed Previous Fusion.

The Camber Spine Alcantara Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The Camber Spine Alcantara Thoracolumbar Plate System is an anterior/ anterolateral/ lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). The Camber Spine Alcantara Thoracolumbar Plate System consists of plates that include bone screw holes and blocking mechanisms to prevent screw back-out, and bone screws, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies. All Alcantara Thoracolumbar plates and screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The provided text does not describe an AI/ML powered device, but rather a thoracolumbar plate system. Therefore, an analysis of acceptance criteria and study details related to AI/ML device performance is not applicable. The text focuses on the mechanical performance and substantial equivalence of the Alcantara Thoracolumbar Plate System to predicate devices.

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