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The CD HORIZON® Spinal System with or without SEXTANT® intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); 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 pediatic indications noted below.

When used for posterior non-cervical pediatic 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 pediatic patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/ or trauma. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CDHORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the noncervical spine (TI-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 CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, medical grade cobalt chromium molybdenum alloy, or medical grade PEEK OPTIMA-LTI. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite.

The purpose of this 510(k) is to add additional non-sterile rods to the CD HORIZON® Spinal System. The type of rods includes a series of tapered and straight rods. The subject rods are manufactured out of medical grade cobalt-chromium-molybdenum alloy.

The subject rods along with other components such as metal screws, hooks and other connecting components are intended to help provide immobilization of spinal segments as an adjunct to fusion of thoracic, lumbar, and/or sacral spine.

This document is a 510(k) premarket notification for the CD HORIZON® Spinal System and primarily focuses on establishing substantial equivalence for new, additional non-sterile rods being added to an existing system. It describes mechanical testing performed to demonstrate that these new rods do not introduce new risks and meet predetermined acceptance criteria, thereby making them substantially equivalent to previously cleared predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, adhering to your requested format:

1. A table of acceptance criteria and the 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)

• Sample Size: The document does not specify the exact number of test samples (e.g., number of rods tested) for each mechanical test. It only states that "Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices."
• Data Provenance: The data provenance is internal to Medtronic, a U.S.-based company (Memphis, TN). This is a premarket submission to the FDA, indicating it's part of a regulatory approval process conducted by the manufacturer. The testing described is prospective, as it was performed specifically for this 510(k) submission.

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 document describes mechanical testing of a spinal implant. It does not involve human anatomical data, image analysis, or clinical evaluation requiring expert medical interpretation to establish "ground truth." Therefore, this section is not applicable. The "ground truth" here is adherence to engineering standards and predetermined mechanical performance criteria.

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

As this study is mechanical testing of a medical device against engineering standards, an "adjudication method" in the context of expert review of clinical data (like 2+1 or 3+1) is not applicable. The "adjudication" is determined by whether the test results meet predefined physical and mechanical thresholds outlined in the ASTM standards.

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

No MRMC study was performed. This document relates to the mechanical testing of spinal system components (rods) and not to an AI/imaging device requiring human reader interpretation studies.

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

No standalone algorithm performance study was done. This document is for a physical medical device (spinal rods), not a software algorithm.

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

The "ground truth" for this study is defined by established engineering standards and predetermined acceptance criteria outlined in ASTM F1798 and ASTM F1717. The device passes if its mechanical properties (e.g., static and fatigue properties) meet these specified thresholds.

8. The sample size for the training set

Not Applicable. This document describes mechanical testing for a physical device, not an AI or machine learning algorithm that requires a "training set."

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

Not Applicable. As there is no training set for an AI algorithm, the ground truth establishment method for a training set is not relevant here.

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