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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 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 CDHORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-SI) 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 submission is to modify Medtronic's CD HORIZON® Spinal System to add additional components to the system, specifically, modified Side Loading/Closed Domino Connectors.

The provided document is a 510(k) summary for the CD Horizon® Spinal System, a medical device for spinal fixation. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with acceptance criteria.

The document explicitly states: "No clinical testing was performed" (Section XI).

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study was conducted for this specific 510(k) submission.

The manufacturer is submitting for a modification to an already marketed device, adding "modified Side Loading/Closed Domino Connectors." The regulatory strategy relies on non-clinical testing and comparison to previously cleared predicate devices.

Here's a breakdown of why the requested information cannot be provided based on the given text:

1. A table of acceptance criteria and the reported device performance: Not available. Since no clinical testing was performed, there are no reported device performance metrics against acceptance criteria from a clinical study.
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. No clinical test set was used.
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. No clinical test set with ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set was used.
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 device is a mechanical spinal system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mechanical spinal system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical study requiring ground truth was performed for this 510(k).
8. The sample size for the training set: Not applicable. This is a medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Instead of clinical testing, the submission relies on:

• Risk analysis: "A risk analysis of the device modifications was completed in accordance with Medtronic design control procedures. The risk analysis, which included an engineering rationale, demonstrated that the subject CD HORIZON® Spinal System does not introduce new issues of safety or effectiveness." (Section X)
• Substantial Equivalence to predicate devices: The modification is deemed substantially equivalent to "Medtronic's CD HORIZON® Spinal System K090390 (S.E. 05/15/2009) and CD HORIZON® Spinal System K101074 (S.E. 06/22/2010)." This means the new components are considered safe and effective because similar components already on the market have demonstrated safety and effectiveness.

For devices like the CD Horizon® Spinal System undergoing minor modifications, regulatory bodies often accept non-clinical evidence (like engineering rationale and comparison to predicate devices) if the changes do not introduce new safety or effectiveness concerns.

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