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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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The Curiteva Thoracolumbar Plate System Two Hole and Four Hole Plates are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability, or via the anterior surgical approach below the bifurcation of the greatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation is achieved.

The Curiteva Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-SI ) 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 anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

The Curiteva Thoracolumbar Plate System is an internal fixation device for spinal surgery that consists of various configurations of spinal plates and bone screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. All system implants are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

The provided text is a 510(k) premarket notification for the Curiteva Thoracolumbar Plate System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices based on technological characteristics and non-clinical performance data.

However, the document does not contain information related to software, artificial intelligence (AI), diagnostic performance metrics, or clinical studies involving human readers or ground truth established by experts/pathology/outcomes data.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established, as this information is not present in the provided text.

The "Performance Data" section (F) explicitly states that "Non-clinical testing performed on the Curiteva Thoracolumbar Plate System supports substantial equivalence to predicate devices." It then lists biomechanical tests (static and dynamic compression bending, static torsion, static and dynamic cantilever bending) according to ASTM standards. These are engineering performance tests for a physical medical device, not diagnostic performance criteria for software or AI.

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