(114 days)
The CD HORIZON® system is intended for the following indications:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is 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.
When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:
When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (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. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® ECLIPSE® components are intended for the following indications: When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is 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® 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.
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, stainless steel CD HORIZON® 4.5mm rods and associated components may be used posteriorly.
The purpose of this 510(k) submission is to expand the length range of the CD HORUZON® ECLIPSE Cannulated Screws and to add an 8.5mm diameter CD HORIZON® ECLIPSE screw to the system.
This document is a 510(k) premarket notification for the CD HORIZON® Spinal System. It seeks to expand the length range of the CD HORIZON® ECLIPSE Cannulated Screws and add an 8.5mm diameter CD HORIZON® ECLIPSE screw to the system.
The document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical or diagnostic algorithm.
Instead, this document focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (in this case, the CD HORIZON® Spinal System itself). The "study" mentioned here is a "Summary of Safety and Effectiveness" report which, in the context of a 510(k) for a spinal implant, primarily involves showing that the modifications or additions to the existing device have the same technological characteristics, indications for use, and safety and effectiveness profile as the predicate device.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets, training set sample size, ground truth establishment for training set) are not applicable to this type of regulatory submission and the information provided.
Here is a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device for expanded screw lengths and diameters. | The CD HORIZON® Spinal System (with added components) was found to be "substantially equivalent" to itself (the predicate device) by the FDA. This implies that the device is considered safe and effective for its stated indications for use, similar to the existing device. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document does not describe a clinical performance study with a test set of data for a diagnostic or AI device. The submission is for a spinal implant and relies on demonstrating substantial equivalence to an existing device rather than presenting new performance data from a clinical trial in the way an AI/diagnostic device would. The "data provenance" would relate to engineering specifications, material properties, and potentially limited biomechanical testing, but not clinical patient data in the context of an "AI test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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, not an AI or diagnostic imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a spinal implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For a medical device like a spinal implant under a 510(k) submission emphasizing substantial equivalence, the "ground truth" refers to established safety and effectiveness of the legally marketed predicate device, as well as adherence to recognized standards for materials, manufacturing, and design. There isn't a "ground truth" derived from patient diagnostic data in the same way there would be for an AI diagnostic tool.
8. The sample size for the training set:
- Not Applicable. See point 2.
9. How the ground truth for the training set was established:
- Not Applicable. See point 2.
In summary: The provided document is a 510(k) summary for a spinal implant. The "acceptance criteria" and "study" are primarily focused on demonstrating "substantial equivalence" to a predicate device, as opposed to presenting detailed performance metrics from a clinical study for a diagnostic or AI-driven device. Therefore, much of the requested information is not relevant or available within this type of regulatory submission.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.