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The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation 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.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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; pseudoarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); 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 rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. 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® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The purpose of this 510(k) submission is to include additional plates and multi-axial screw components to the CD HORIZON® Spinal System.

The provided text is a 510(k) summary for the CD HORIZON® Spinal System. This type of regulatory submission in the U.S. demonstrates substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving performance is not present in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Not provided. The document focuses on demonstrating substantial equivalence to previously cleared devices (K032265 and K031655) for the purpose of adding new components (plates and multi-axial screws) to an existing system, not on meeting predefined performance criteria through a new study.

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

Not applicable. No new study data is presented. The submission relies on the predicate devices' prior clearances.

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 new study data is presented.

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

Not applicable. No new study data is presented.

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 a spinal implant system, not an AI-assisted diagnostic or treatment device.

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

Not applicable. This is a spinal implant system, not an algorithm-only device.

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

Not applicable. The "ground truth" in a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device(s) and the demonstration that the new device or components do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable.

Summary of available information from the document:

The document, K041777, is a 510(k) premarket notification for the CD HORIZON® Spinal System, specifically for the addition of plates and multi-axial screw components.

• Substantial Equivalence: The primary "proof" in this document is the demonstration of substantial equivalence to previously cleared devices: K032265 (cleared 8/11/03) and K031655 (cleared 06/27/03). This means the manufacturer argued that the new components are as safe and effective as the predicate devices, and perform similarly to the previously cleared versions of the CD HORIZON® Spinal System.
• Intended Use/Indications: The document extensively lists the indications for use for the CD HORIZON® Spinal System, including posterior, non-cervical fixation for conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. It also specifies indications for percutaneous approaches, anterolateral thoracic/lumbar systems (with ECLIPSE® components), and the CD HORIZON® SPIRE Plate.

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