(30 days)
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 components to the CD HORZON® Spinal System.
This document describes a 510(k) premarket notification for the "CD HORIZON® Spinal System" and focuses on demonstrating "substantial equivalence" to a predicate device, rather than presenting a study with acceptance criteria and device performance metrics.
Therefore, many of the requested elements about acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. | Not applicable. |
| Explanation: The document does not specify quantitative acceptance criteria or provide performance metrics (e.g., success rates, complication rates, mechanical strength) for the device. The submission's goal is to demonstrate "substantial equivalence" to an existing device, not to prove performance against pre-defined criteria. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The document does not describe a clinical or lab study with a test set of data.
- Data Provenance: Not applicable. No data or study results are presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment activity for a test set is described.
4. Adjudication method for the test set
- Not applicable. No adjudication method is described as there is no test set or expert review process.
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 submission for a spinal implant system, not an AI-powered diagnostic device. No MRMC study or AI-related information is present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth is established as there are no performance studies described. The "ground truth" for this type of submission is the legally marketed predicate device to which the new device is compared for substantial equivalence.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is a medical device submission, not an AI/machine learning model.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of what the document does provide:
The document is a 510(k) Premarket Notification for the CD HORIZON® Spinal System. Its primary purpose is to demonstrate Substantial Equivalence to itself (meaning, additional components are being added to an already cleared system without changing its core function or safety profile).
- Device Description: It details the various components of the CD HORIZON® Spinal System (rods, hooks, screws, etc.) and states its intended use to provide immobilization and stabilization as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. It also mentions compatibility with components from other Medtronic Sofamor Danek systems.
- Indications for Use: Multiple indications are listed for posterior, non-cervical fixation, percutaneous SEXTANT instrumentation, and anterolateral thoracic/lumbar systems. These include degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion.
- Substantial Equivalence: The key "study" mentioned here is the documentation demonstrating the CD HORIZON® Spinal System to be "substantially equivalent to itself." This implies that the new components being added do not alter the fundamental safety and effectiveness profile such that it would require approval as a new device. The FDA's letter confirms this finding.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.