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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degencration 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; pseudarthritis; and/or failed provious fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.

The CD HORIZON SPIRE™ Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.

In order to achieve additional levels of fixation as an adjunct to fusion, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The purpose of this submission is to meet our surgeon's needs by adding more connection options, filling in sizes that have not previously existed, and to add an open-connection feature for the rods.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and associated screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite. Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The provided text is a 510(k) summary for the CD HORIZON® Spinal System and primarily focuses on describing the device, its components, materials, and intended use. It also mentions substantial equivalence to predicate devices based on mechanical testing.

However, the document does not contain information about:

• Specific acceptance criteria for device performance.
• Any clinical study designed to prove the device meets specific acceptance criteria.
• Details on sample size for test sets, data provenance, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies.
• Standalone algorithm performance, training set size, or how ground truth was established for a training set. (These topics usually relate to AI/ML device evaluations, which don't seem applicable to this spinal system submission).

The summary states: "The results of the mechanical testing performed for the subject CD HORIZON® Spinal System components were equivalent to the testing performed for the predicate CD HORIZON® Spinal System and TSRH® Spinal System components." This implies that the device's mechanical performance was deemed acceptable if it matched that of already approved predicate devices.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported device performance, or details about the study that proves the device meets acceptance criteria, as this information is not present in the provided text. The document focuses on regulatory approval through substantial equivalence based on mechanical testing, rather than reporting on specific performance metrics against defined acceptance criteria from a clinical study.

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