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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, 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 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.

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.

The purpose of this 510(k) submission is to add additional transverse hooks to the CD HORIZON® Spinal System. These additional transverse hooks contain two changes from the predicate 2, CD HORIZON Spinal System, 1) a modified hook blade angle, and 2) packaged sterile via gamma irradiation. The subject sterile transverse hooks along with other components such as metal rods, screws, and other connecting components are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of thoracic, lumbar, and/or sacral spine. The subject transverse hooks are manufactured out of medical grade titanium alloy per ASTM F136.

The provided document is a 510(k) Summary for the Medtronic CD HORIZON® Spinal System, specifically focusing on the addition of new transverse hooks. This document outlines the device's characteristics, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or algorithm validation study would.

Instead, this is a regulatory submission for substantial equivalence to already approved devices. The "performance data" section focuses on biocompatibility and mechanical testing, which are assessed through engineering rationale and comparison to existing standards and predicate devices, rather than a study with acceptance criteria and reported device performance metrics in the context of diagnostic accuracy or clinical outcomes.

Here's an analysis based on the information provided, explicitly stating where information is not present:

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

• Not Applicable in this document's context. This 510(k) submission does not present acceptance criteria and reported performance in the manner of a clinical or algorithm study (e.g., sensitivity, specificity, accuracy). Instead, it demonstrates substantial equivalence through:
  • Biocompatibility: Conformance to FDA's Draft Guidance for ISO-10993 and use of ASTM F136 compliant material with a long clinical history.
  • Mechanical Testing: Engineering rationale demonstrating that the subject devices do not represent a new worst-case compared to predicate devices, and thus no additional testing was required.

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

• Not Applicable. This document describes a submission for device modification based on substantial equivalence, relying on engineering rationale and existing material standards rather than human subject data or a test set as defined for AI/algorithm performance.

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 the context of a clinical or algorithm study is not relevant here. The evaluation is based on material science, mechanical properties, and regulatory guidance.

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

• Not Applicable.

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 not a study involving human readers or AI assistance.

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

• Not Applicable. This involves a medical implant, not an algorithm.

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

• Not Applicable. The "truth" in this context is adherence to biomechanical principles, material standards (ASTM F136), and biological safety standards (ISO-10993), as well as being demonstrably equivalent to previously cleared predicate devices.

8. The sample size for the training set

• Not Applicable. This is a hardware modification for a spinal implant, not an AI/algorithm.

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

• Not Applicable.

Summary of what the document does provide regarding device performance and acceptance:

The document states that the new transverse hooks for the CD HORIZON® Spinal System met the requirements for substantial equivalence by:

• Biocompatibility: The devices were evaluated in accordance with FDA's Draft Guidance for ISO-10993. Since they are permanent implants (>30-day body contact) and manufactured from "identical materials as the predicate devices" (medical grade titanium alloy per ASTM F136), and this material has a "long clinical history of use in similar medical devices," no additional biocompatibility testing was required. This implies the acceptance criteria for biocompatibility were met by demonstrating material equivalence to a well-established, safe material.
• Mechanical Testing: According to the "Guidance for Industry and FDA Staff - Spinal System 510(k)'s", Medtronic evaluated the devices. It was determined that the "subject devices do not represent a new worst case" and an "engineering rationale was used to demonstrate substantial equivalence." This means the acceptance criterion for mechanical performance was met by proving, through engineering analysis, that the modified hooks perform at least as well as the predicate devices and do not introduce new mechanical risks. No additional mechanical testing was required because the engineering rationale was deemed adequate.

The "study" that proves the device meets (or is equivalent to) the functional and safety requirements is the engineering rationale and comparison to predicate devices, along with adherence to recognized standards for materials (ASTM) and biological evaluation (ISO). There are no specific quantitative metrics or statistical analyses described in this particular section of the 510(k) summary for such a "study" as one might find for a diagnostic or AI device.

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