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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 discase (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic sudies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis 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. The CD HORIZON® Pediatric Spinal System is intended to be used with autograft and/or allografi. Pediatric pedicle screw fixation is limited to a posterior approach.

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 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 Meduronic 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 HORZON® Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, CD HORIZON® SPIRE spinous process plate devices, Shape Memory Alloy Staples, DYNALOK® bolts, TSRH® screws and washers. 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 cobaltchromium-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 and 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 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 anterios 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.

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-LT1 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 510(k) submission is to expand the indications of use to allow for use of pedicle screw based constructs to treat pediatric patients.

The provided text is a 510(k) summary for the CD HORIZON® Spinal System, focusing on expanding its indications for use in pediatric patients. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the manner typically seen for AI/ML devices.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this document.

However, I can extract information related to the device's intended use and the "clinical assessment" provided in support of its expanded indication.

Here's the breakdown based on the provided text, noting where information is not available or not applicable:

1. A table of acceptance criteria and the reported device performance

This document describes a medical device, not an AI algorithm. It does not provide explicit acceptance criteria in terms of performance metrics (like sensitivity, specificity, or AUC) that would be evaluated by a study, nor does it report device performance in that way. Instead, it refers to the collection of clinical data to support the expanded indication.

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

This information is not explicitly detailed in the 510(k) summary for a "test set" in the context of an AI device. The document mentions "Published clinical data of pediatric patients" but does not specify the design (retrospective/prospective) or country of origin.

• Sample Size: "More than 600 pediatric patients treated with pedicle screw constructs alone" and "more than 900 patients treated with a hybrid construct." (Total >1500 pediatric patients). This is referred to as clinical data supporting the expanded indication, not a "test set."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is referred to as "Published clinical data."

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)

This is not applicable as the document describes a spinal implant system, not a device requiring ground truth established by experts in an AI context. The "ground truth" would be the clinical outcomes and diagnoses of the patients, established by treating clinicians.

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

This is not applicable. The document refers to clinical patient data and outcomes, not an adjudication process for labeling an AI test set.

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

This is not applicable. The device is a spinal implant system, not an AI-assisted diagnostic tool.

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

This is not applicable as it is not an AI algorithm.

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

For the clinical data provided, the "ground truth" implicitly refers to the clinical outcomes and diagnoses of the pediatric patients treated for adolescent idiopathic scoliosis, as determined by their treating physicians. This would encompass aspects like the initial diagnosis, surgical success, fusion rates, complication rates, and long-term functional outcomes, which are standard for clinical studies of medical devices.

8. The sample size for the training set

This is not applicable as it is not an AI algorithm.

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

This is not applicable as it is not an AI algorithm.

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