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The CD HORIZON® Spinal System with or without SEXTENT® instrumentation 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 and/or lordosis); tumor; pseudarthritis; 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.

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.

The CD HORIZON® SPIRE Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion 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 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 modify the CD HORIZON® Spinal System package insert by removing certain contraindications. Additionally, the wording of the indications of use section has been modified to eliminate certain redundancies.

The provided document is a 510(k) summary for the CD HORIZON® Spinal System. This type of submission is for demonstrating substantial equivalence to a previously legally marketed device, not for proving a device meets specific acceptance criteria through a performance study in the way an AI/ML device would.

Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this document.

Here's why and what the document does discuss:

1. Acceptance Criteria and Reported Device Performance:

• Not applicable. The document does not describe acceptance criteria for a new device's performance nor does it report performance metrics in the context of a new study proving safety and effectiveness. Instead, it argues that changing the package insert and indications of use wording does not alter the already accepted safety and effectiveness of the device, which was established by its substantial equivalence to predicate devices.

2. Sample Size for Test Set and Data Provenance:

• Not applicable. No test set was used because no new performance study was conducted.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. No ground truth was established for a new performance study.

4. Adjudication Method:

• Not applicable. No adjudication was performed as no new performance study was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, not performed. This submission is not for an AI/ML device, nor does it present any new clinical study data that would involve human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study:

• No, not performed. This type of study is relevant for AI/ML devices. The CD HORIZON® Spinal System is a mechanical implant.

7. Type of Ground Truth Used:

• Not applicable. No new ground truth was established for a performance study. The "truth" in this context is the FDA's existing determination of safety and effectiveness for spinal fixation systems.

8. Sample Size for Training Set:

• Not applicable. This relates to AI/ML development, which is not relevant here.

9. How Ground Truth for Training Set Was Established:

• Not applicable.

What the Document Does State Regarding "Acceptance" (in the context of a 510(k) submission):

The core of this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices. The "acceptance criteria" in this context are tied to showing that modifications (removing contraindications, rephrasing indications) do not affect previous determinations of safety and effectiveness.

• V. Indications: The document lists the specific indications for which the CD HORIZON® Spinal System is intended. These are:

  • Degenerative disc disease
  • Spondylolisthesis
  • Trauma (fracture or dislocation)
  • Spinal stenosis
  • Curvatures (scoliosis, kyphosis, lordosis)
  • Tumor
  • Pseudarthrosis
  • Failed previous fusion

• VI. Substantial Equivalence: This section explicitly states the "study" (or rather, the argument) that proves the device continues to meet the safety and effectiveness bar set by its predicates:

  • "This submission reflects merely a wording change and therefore no additional testing is required."
  • "The modifications to the package insert and to the wording of the indications of use do not alter the safety and effectiveness of the device, nor do they impose any additional risks to the patient."
  • The wording changes are claimed to be "equivalent to that found in package inserts for similar spinal device system including the Moss Miami Spinal System (DePuySpine - K030383, SE 02/26/03) and the Pangea™ Degenerative Spine System (Synthes - K052151, SE 12/07/05)."

In summary, for K061304, the "acceptance criteria" are implicitly that the modified labeling does not negatively impact the already established substantial equivalence of the CD HORIZON® Spinal System to its predicate devices. The "study" proving this is the argument presented to the FDA that the changes are minor and consistent with predicate devices.

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