Search Results

The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion 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, 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® System implants are indicated as an adjunct 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 Special 510(k) is to obtain clearance for the minor print changes to the dimensioning scheme for Percutaneous Rod Inserter, which was originally cleared in CD HORIZON® Spinal System K132639 (S.E. 11/25/2013). The minor print changes include modifications to hard dimensions/tolerances and Geometric Dimensioning and Tolerances (GD&T) for ease of manufacturing, as well as the addition of a laser mark for visual purposes to the end user.

This document is a 510(k) premarket notification for a modification to an existing medical device, the CD HORIZON® Spinal System, specifically for a Percutaneous Rod Inserter. It's a submission to the FDA, arguing for substantial equivalence to a previously cleared device. Therefore, it does not contain the kind of detailed acceptance criteria and study data typically found in an original device approval or a clinical trial report for AI/software devices.

Here's an analysis based on the provided text, highlighting why most of your requested information is not present:

Key Takeaway: This submission is for minor print changes to an existing Percutaneous Rod Inserter (a physical surgical tool), not for an AI/software device or a new medical device requiring extensive performance studies. The "performance data" section focuses on demonstrating that these minor changes do not negatively impact the device's safety or effectiveness compared to the predicate, rather than establishing new performance metrics.

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

• Not Applicable in the traditional sense for this document. This document is for a mechanical device modification, not a software or AI device with performance metrics like sensitivity, specificity, accuracy, etc.
• The "acceptance criteria" here implicitly revolve around ensuring the modified design of the Percutaneous Rod Inserter (minor print changes, hard dimensions/tolerances, GD&T, laser mark) does not compromise the device's safety and effectiveness compared to the predicate device.
• Reported device performance: The document states that a "risk analysis," "print review," "mechanical strength rationale," and "tolerance stack analysis" were completed. These analyses "demonstrated that the minor print changes... do not introduce new issues of safety or effectiveness." This is the reported performance in the context of this submission – that the changes are benign.

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 is a design/engineering assessment of manufacturing changes, not a clinical study on a test set of data. There isn't a "test set" in the sense of patient data or clinical images. The "sample" implicitly refers to the device design itself and its components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. There is no "ground truth" establishment in this document as it's not a diagnostic or AI device being evaluated against a clinical gold standard. The "experts" would likely be Medtronic's internal engineers and quality assurance personnel conducting the risk analysis and design reviews, but their number and specific qualifications are not detailed here.

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

• Not Applicable. No test set or clinical judgment/adjudication involved in this type of submission.

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 explicitly not an AI device. No MRMC study was performed.

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

• Not Applicable. Not an algorithm or AI device.

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

• Not Applicable. No clinical ground truth is established or used for this submission. The "ground truth" for the assessment is the predicate device's established safety and effectiveness, and the current submission aims to show the modified device is equally safe and effective through engineering analysis.

8. The sample size for the training set:

• Not Applicable. No training set, as this is not an AI/machine learning device.

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

• Not Applicable. No training set or ground truth in this context.

Summary of Relevant Information from the Document:

• Device: CD HORIZON® Spinal System (specifically, modifications to a Percutaneous Rod Inserter component).
• Purpose of Submission: Obtain clearance for minor print changes a mechanical component (Percutaneous Rod Inserter), including modifications to hard dimensions/tolerances, Geometric Dimensioning and Tolerances (GD&T) for ease of manufacturing, and the addition of a laser mark for visual purposes.
• Predicate Device: CD HORIZON® Spinal System (K132639, S.E. 11/25/2013).
• Basis for Substantial Equivalence:
  • Technological Characteristics: The modified Percutaneous Rod Inserter has the "same fundamental scientific technology and material" as the predicate. It retains the same locking mechanism, arc orientation, rod orientation, and clamping mechanism.
  • Materials: Manufactured from the same Medical Grade Stainless Steel (MGSS) and silicone as the predicate device, which have "a long history of safe and effective use; therefore, biocompatibility testing is not required."
  • Performance Data (for the modification): A "risk analysis of the print changes was completed in accordance with Medtronic design control procedures." This included a "print review, mechanical strength rationale, and tolerance stack analysis." These analyses "demonstrated that the minor print changes... do not introduce new issues of safety or effectiveness; therefore, no additional testing is required."
• Conclusion: The subject Percutaneous Rod Inserter is considered "as safe and effective as the following predicate" based on the risk analysis and supporting documentation.

Ask a specific question about this device