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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 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 fusjon.

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, single level, 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.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washer, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to 3.5mm, 4.5mm, 5.5mm rods or 6.35mm rods, while other components can connect to both 5.5mm rods and 6.35mm rods. Care should be taken so that the correct components are used in the spinal construct.

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 cobalt-chromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite. No warranties express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog for further information about warranties and limitations of liability

Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy and/or medical grade cobaltchromium-molybdenum 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 CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy and cobalt-chromiummolybdenum alloy. Do not use with stainless steel.

PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium or cobalt-chromium-molybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates.

To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.

This is a 510(k) premarket notification for a spinal system, which falls under the category of medical devices. The provided document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, not clinical studies involving human or AI performance. Therefore, many of the requested criteria regarding human readers, AI, and clinical ground truth are not applicable to this type of submission.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The document does not specify a distinct "sample size" for a clinical test set as this is a mechanical testing submission. The "samples" would be the actual spinal system components tested. The number of components tested for each mechanical test is not explicitly stated but would be part of the standard testing requirements for ASTM F1798 and F1717.
• Data Provenance: Not applicable in the context of a clinical study. The testing was mechanical, performed to ASTM standards. The location of the testing is not specified, but it would typically be conducted in a laboratory.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. Ground truth in this context is established by the successful completion of standardized mechanical tests, not by expert interpretation of clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. There is no adjudication method for a clinical test set in this mechanical testing submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a 510(k) submission for a spinal implant system based on mechanical equivalence, not an AI-powered diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical spinal implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the mechanical tests, the "ground truth" is defined by the pass/fail criteria established within the referenced ASTM standards (F1798 and F1717). The components either meet the specified mechanical performance thresholds or they do not.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/machine learning device.

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