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The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined by back pain of discogenic origin with degeneration of the disc confirmed by patient 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 by back pain of discogenic origin with degeneration of the disc confirmed by patient 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, 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, 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 by back pain of discogenic origin with degeneration of the disc confirmed by patient 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 add modified CD HORIZON® SEXTANT instruments to the CD HORIZON® Spinal System.

The provided text is a 510(k) premarket notification for the CD HORIZON® Spinal System. This document describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way you've outlined for an AI/algorithm-based device.

Here's why and what's missing:

• Device Type: The CD HORIZON® Spinal System is a physical spinal implant (rods, hooks, screws, plates, etc.). It's not an AI or algorithm-based diagnostic or assistive device that would have performance metrics like sensitivity, specificity, or AUC based on processing data.
• Regulatory Pathway: A 510(k) submission demonstrates substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, often through material testing, mechanical testing, and sometimes bench or animal studies, not clinical studies demonstrating diagnostic accuracy or algorithmic performance against ground truth.
• Lack of Performance Data: The document focuses on product description, indications for use, and a declaration of substantial equivalence to previously cleared devices (K001255 and K001066). There are no sections detailing clinical studies with quantifiable performance metrics, sample sizes for test sets, expert ground truth establishment, or any of the other criteria you listed for an AI study.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text. The requested information is pertinent to AI/machine learning device evaluations, which is not the subject of this 510(k) submission for a physical spinal implant system.

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