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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 following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous 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 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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

In order to achieve additional levels of fixation, 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 subject CD HORIZON® Solera™ Spinal System offers dual rod multi-axial screws (DRMAS) that have an opened head. The subject screws offer the ability to place two rods in parallel. The subject DRMAS are provided sterile.

The provided text is a 510(k) summary for the Medtronic CD HORIZON® Spinal System. It describes the device's indications for use, comparison to predicate devices, and performance data from mechanical testing and biocompatibility assessments.

However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document describes a spinal implant system, not a software or AI/ML device. The "performance data" section refers to mechanical testing (Static Compression, Static Torsion, Compression Fatigue, Axial Grip, Axial Torsional Grip, Flexion Extension Fatigue) and biocompatibility of the physical implant components, not performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI/ML device.

Therefore, the requested information specifically related to acceptance criteria and studies proving an AI/ML device meets them, along with details about sample sizes, data provenance, ground truth establishment, expert qualifications, and MRMC studies, cannot be extracted from this document.

The document primarily focuses on demonstrating substantial equivalence of a physical medical device (spinal system) to predicate devices through material properties and mechanical performance.

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