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The STRUXXURE®-L and STRUXXURE®-A Plate System is indicated for treatment of spine instability via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracolumbar (T1-L5) spine or via an anterior surgical approach below the bifurcation of the great vessels in the lumbar and lumbosacral (1-S1) spine. The indications for use include fracture (including dislocation and subluxation), turnor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, spondylolisthesis, pseudarthrosis and failed previous spine surgery.

The STRUXXURE®-L System may also be attached to NEXXT MATRIXX® Lateral interbody devices. The STRUXXURE®-A Plate System may also be attached to NEXXT MATRIXX® ALIF interbody devices. In these configurations the STRUXXURE®-L and STRUXXURE®-A Plate System is used to treat skeletally mature patients having DDD at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The STRUXXURE®-L and STRUXXURE®-A Plate System is a lumbar plate and screw system. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient. The implants are sold non-sterile.

The provided text describes a 510(k) premarket notification for a medical device called the "STRUXXURE®-L and STRUXXURE®-A Plate System." It confirms the device's substantial equivalence to legally marketed predicate devices based on its intended use and technological characteristics. However, the document does not contain the specific information requested about acceptance criteria for device performance, nor details of a study proving those criteria are met for AI/ML-based device performance.

The document focuses on the regulatory clearance process for a traditional, non-AI/ML spinal plate system, comparing its mechanical properties and design to a predicate device. It explicitly states:

• "Mechanical testing of the worst case STRUXXURE®-L and STRUXXURE®-A Plate System construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. In addition, screw backout testing and cage-plate dissociation testing were performed. The mechanical test results demonstrate that the STRUXXURE®-L and STRUXXURE®-A Plate System performance is substantially equivalent."

This indicates that the "study" demonstrating performance is mechanical testing against an ASTM standard, rather than a clinical study evaluating diagnostic accuracy or a comparative effectiveness study involving human readers and AI.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these types of details are not present in the provided text for an AI/ML device.

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