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The EDEN Spinal Fixation System is intended to provide immobilization and stabilization of the posterior, non- cervical spine as an adjunct to fusion in 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, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

The EDEN Spinal Fixation System can be used in an open approach and a percutaneous approach with MIS instrumentation.

The EDEN Spinal Fixation System is a pedicle screw and rod system intended for immobilization and stabilization of the spine as an adjunct to fusion. The EDEN Spinal Fixation System consists of pedicle screws, rods, cross links, and set screws that can be used via percutaneous surgical approach. The components are available in a variety of designs and sizes in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F136). The implants will be provided non-sterile.

The EDEN Spinal Fixation System also offer a wide variety of instrument that range from bone awls to screwdrivers.

They are made of various grades of stainless steel and aluminum alloys. All the items are supplied non-sterile and must be sterilized prior to use.

This document, an FDA 510(k) Premarket Notification review, pertains to the EDEN Spinal Fixation System. It does not describe an AI medical device or a study proving that an AI medical device meets specific acceptance criteria in the manner requested.

Therefore, I cannot extract the information required to populate the table and answer the questions about AI device performance, sample sizes, ground truth establishment, or human-in-the-loop studies. The document focuses on the substantial equivalence of a physical medical device (spinal fixation system) to a predicate device based on material, design, and non-clinical mechanical testing, rather than the performance of an AI algorithm.

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