(30 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 tumor, 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 also 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) turnor 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.
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. When connecting to the VERTEX™ Reconstruction System in the cervical spine, components are intended for the following indications:
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEXTM Reconstruction System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Multi-axial Screws/Lateral Connectors
The use of VERTEX™ multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine.
Titanium ATLAS™ Cable and the CD HORIZON® Spinal System may be used with the VERTEXTM Reconstruction System.
The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components, as well as implant components from other Medtronic Sofamor Danek spinal systems, which can be rigidly locked in 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. Please note that certain components are specifically designed to connect to 4.5mm, 5.5mm diameter rods, while other components can connect to both 5.5mm and 6.35mm rods. Care should be taken so that the correct components are used in the spinal construct.
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 CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F1314 or ISO 5832-1 or ISO 5832-9. Alternatively, the entire system may be made out of medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2. Medtronic Sofamor Danek expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for further information about warranties and limitations of liability. Never use stainless steel and titanium implant components in the same construct.
The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium implants only. Do not use with stainless steel.
The purpose of this 510(k) submission is to add components to the existing CD HORLZON® Spinal System.
Acceptance Criteria & Performance Study for CD HORIZON® Spinal System
Based on the provided document, the CD HORIZON® Spinal System is a medical device for spinal fixation. It received 510(k) clearance, which is a premarket notification demonstrating that the device is substantially equivalent to a legally marketed predicate device. This type of clearance does not typically involve a formal study with acceptance criteria and a detailed statistical performance analysis in the same way a PMA (Premarket Approval) would.
Therefore, the "acceptance criteria" for this device, as per a 510(k) pathway, are met by demonstrating substantial equivalence to a legally marketed predicate device. The "study" proving this is the substantial equivalence comparison itself.
Here's an breakdown based on the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for 510(k) pathway) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Substantial Equivalence: The device must be as safe and effective as a legally marketed predicate device. This is typically assessed by comparing: | Demonstrated Substantial Equivalence: The CD HORIZON® Spinal System was found to be substantially equivalent to itself, implying that the new components or system modifications maintain the same safety and effectiveness profile as the existing, cleared CD HORIZON® Spinal System. |
| - Intended Use: Similar indications for use. | The indications for use are clearly defined and consistent with spinal fixation systems. |
| - Technological Characteristics: Similar materials, design, and operating principles. | The device consists of rods, hooks, screws, plates, staples, and other connecting components made from medical grade stainless steel or titanium/titanium alloy. These characteristics are consistent with existing spinal fixation systems. Nitinol components are specified for use with titanium implants only. |
| - Performance Data (if applicable and necessary): Mechanical testing, biocompatibility, etc. to ensure that any differences in technological characteristics do not raise new questions of safety or effectiveness. | While not explicitly detailed in this summary, a 510(k) submission would typically include bench testing (e.g., fatigue strength, pull-out strength) and material characterization to support the safety and mechanical integrity of the components, ensuring they perform comparably to the predicate. Biocompatibility testing would also be required for the materials used. |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" or clinical study with a specific sample size in the traditional sense for evaluating device performance against acceptance criteria. The 510(k) submission relies on comparison to a predicate device ("itself" in this case), which means the "data" is primarily a technical and indications-for-use comparison rather than original clinical or performance data from a new test set.
- Sample Size: Not applicable in this context as no new patient or subject data is presented for a "test set."
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document does not involve a "test set" requiring expert consensus for ground truth. The substantial equivalence assessment is performed by the FDA reviewers based on the technical description and comparison provided by the manufacturer.
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Since there is no "test set" requiring ground truth establishment by experts, an adjudication method is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done as described in this document. This typically applies to diagnostic devices where human readers interpret results with and without AI assistance. The CD HORIZON® Spinal System is a surgical implant, not a diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone (algorithm-only) performance study was not done. The CD HORIZON® Spinal System is a mechanical implant, not an algorithm or AI-driven device.
7. The Type of Ground Truth Used
For a medical device cleared via the 510(k) pathway, the "ground truth" for demonstrating safety and effectiveness is the established safety and effectiveness of the legally marketed predicate device. In this specific case, the "ground truth" is based on the previously cleared CD HORIZON® Spinal System components and the broader class of similar spinal fixation devices.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical implant, not a machine learning model, so there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.