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The Adena-Zina System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

The Adena-Zina System consists of a variety of shapes and sizes of screws, 5.5mm and 6.35mm rods, and other connecting components that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. All implant components are made from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3 or cobalt chrome alloy per ASTM F1537-11/ISO 5832-12.

The purpose of this submission is to add the Duetto dual headed Screws and connectors, along with associated set screws to the Adena-Zina Spinal System.

The provided text pertains to an FDA 510(k) premarket notification for the "Adena-Zina System," a thoracolumbosacral pedicle screw system. This document outlines the regulatory clearance process for a medical device and describes its intended use, materials, and a declaration of substantial equivalence to predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI/ML algorithm or software functionality. The "Performance Testing" section only mentions bench testing for mechanical properties (static compression, static torsion, and dynamic axial compression) of the screws, as per ASTM F1717-18, which is standard for spinal implants, not for software performance or diagnostic accuracy.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them concerning AI/ML performance, because the provided input does not contain this information. The document focuses on the physical device and its mechanical properties.

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