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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 and/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® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. 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.

A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates, and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD HORIZON® Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, SPIRE™ Plates and DYNALOK® bolts. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System in non-pediatric cases. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples, washers, 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 specific rod diameters, while other components can connect to multiple rod diameters. 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 and pediatric patients. 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. No warranties expressed 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 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 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-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.

PEEK OPTIMA-LTI implants may be used with stainless steel, titanium, or cobaltchromium-molybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates or in pediatric patients.

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.

The purpose of this SI0(k) was to add SOLERA™ reduction multi-axial screws manufactured out of cobalt chrome, titanium alloy and commercially pure titanium and associated reduction setscrews manufactured out of medical grade titanium alloy to the CD HORIZON® Spinal System for use with 4.75mm diameter rods.

The provided text is a 510(k) Summary for the CD HORIZON® Spinal System (K112473). This document is a premarket notification to the FDA for medical devices and focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials for effectiveness or measuring device performance against specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details demonstrating performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

Here's a breakdown of why the requested information isn't present in this type of document:

• Acceptance Criteria & Reported Performance: The 510(k) pathway is primarily for demonstrating equivalence. It doesn't typically require setting new, quantitative performance acceptance criteria or conducting studies to measure device performance against them in the same way a PMA (Premarket Approval) would. The "performance" discussed here relates to the equivalence to predicate devices, not novel performance metrics.
• Sample Sizes (Test/Training Sets) & Data Provenance: Since no new clinical or standalone performance studies are conducted with explicit test/training sets as one would for an AI/algorithm-based device, these details are absent.
• Number of Experts & Qualifications for Ground Truth: This is relevant for studies establishing ground truth for diagnostic or AI algorithm performance. It's not applicable to a 510(k) for a spinal implant where the "ground truth" is typically established by well-understood biomechanical principles and established clinical practice.
• Adjudication Method: Similar to the above, this is for assessing performance of a diagnostic or AI tool, not for a hardware implant.
• MRMC Comparative Effectiveness Study: This type of study is specifically for evaluating the impact of AI on human reader performance, which is not the subject of this 510(k).
• Standalone Performance Study: This would be for an algorithm's performance without human intervention. This 510(k) is for a spinal implant, which is a physical device used in surgery, not a standalone algorithm.
• Type of Ground Truth Used: For a spinal implant, the ground truth for "effectiveness" is clinical outcomes after implantation, which would be gathered in post-market surveillance or specific clinical trials (not usually part of a 510(k)). The immediate "truth" related to the device's design is its physical characteristics and biomechanical properties, which are compared to predicates.
• Sample Size for Training Set & Ground Truth for Training Set: These are concepts for machine learning model development, not for a physical medical device submission like this one.

What the document does describe related to "testing":

The document mentions "Non-clinical testing in the form of design verification and validation activities was performed on the subject devices to show equivalence to the previously listed predicate devices." It also explicitly states, "Non-clinical testing in the form of mechanical testing was not required for the subject devices since the only difference between them and the predicate devices were the addition of extended tabs on the screw heads and extended threads on the break-off portion of the setscrew."

This indicates that the "study" for this 510(k) was primarily a comparison of design features, materials, and indications for use to predicate devices, and internal design verification/validation activities to ensure the new components met their intended specifications and were equivalent to the existing predicate device components. This is a common approach for modifications to existing devices under the 510(k) pathway.

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