(9 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) 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.
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, (CI-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, or 6.35mm 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. Alternatively, the entire system may be made out of medical grade titanium or titanium alloy. No 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 modified CD HORIZON® ECLIPSE® bone screws to the system.
This document is a 510(k) summary for the CD HORIZON® Spinal System, a medical device. The purpose of this type of submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device.
Let's break down the information provided in the context of acceptance criteria and a study proving those criteria.
Key takeaway: This document is a 510(k) submission, not a study report. Therefore, it does not contain information about specific acceptance criteria and detailed device performance metrics derived from a clinical study (like sensitivity, specificity, accuracy, etc.) for a novel AI/software device. Instead, it focuses on demonstrating "substantial equivalence" of a physical implant (spinal system) to a previously cleared version of itself.
Here's how to address your request based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a physical medical device (spinal implant) and not a clinical study report for an AI/software device, there isn't a traditional "acceptance criteria" table with performance metrics like sensitivity, specificity, or accuracy that would be applicable to an AI or diagnostic device.
The "acceptance criteria" for a 510(k) submission are fundamentally about demonstrating substantial equivalence to a predicate device in terms of:
- Intended use
- Technological characteristics (materials, design, performance standards)
- Safety and effectiveness
The "device performance" in this context refers to the characteristics that allow it to meet the substantial equivalence criteria.
Table: Substantial Equivalence Criteria and Device Characteristics (as per 510(k) process)
| Acceptance Criteria Category (for Substantial Equivalence) | Reported Device Characteristics / Performance |
|---|---|
| Intended Use | CD HORIZON® Spinal System: |
| (Must be the same as or very similar to predicate) | - Pedicle screw fixation system (non-cervical posterior spine) for: degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion (pseudarthrosis), severe spondylolisthesis (Grades 3 & 4 L5-S1) with autogenous bone graft. |
| - Posterior, non-cervical, non-pedicle screw fixation system for: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities, fracture, pseudarthrosis, tumor resection, failed fusion. | |
| - Percutaneous posterior approach with SEXTANT instrumentation for: pedicle screw fixation for severe spondylolisthesis (Grades 3 & 4 L5-S1) with autogenous bone graft, and posterior spine thoracic/lumbar system for: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities, fracture, pseudarthrosis, tumor resection, failed fusion. | |
| - Anterolateral thoracic/lumbar system (ECLIPSE® components) for: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities, fracture, pseudarthrosis, tumor resection, failed fusion. | |
| - Connection to VERTEX™ Reconstruction System (C1-T3) for: DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed fusion, tumors. | |
| Predicate Device: The document states the CD HORIZON® Spinal System is substantially equivalent "to itself" (referencing a previous version of the same product line, K031888 for addition of 6.35 mm rod, implying the prior predicate had similar or identical indications for use). | |
| Technological Characteristics | CD HORIZON® Spinal System: |
| (Must be same as or similar to predicate device.) | - Components: rods, hooks, screws, CROSSLINK® plates, staples, connecting components. |
| - Materials: medical grade stainless steel, medical grade titanium or titanium alloy. | |
| - Anterior staples: Shape Memory Alloy (Nitinol - NiTi), compatible with titanium implants only. | |
| - Specific components connect to 4.5mm, 5.5mm, or 6.35mm diameter rods. | |
| - This submission specifically adds modified CD HORIZON® ECLIPSE® bone screws and 6.35 mm rod to the system. | |
| Safety and Effectiveness | The 510(k) process inherently deems a device safe and effective if it is substantially equivalent to a legally marketed predicate device. The document states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the core "proof" in a 510(k). Specific performance data (e.g., biomechanical testing results) would be in an internal design dossier, not typically summarized in this public document unless there were significant changes requiring new performance testing to demonstrate equivalence. The document refers to "summary of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) submission. This document describes a physical spinal implant system, not a software device requiring a "test set" in the sense of clinical data points for performance evaluation. The "study" mentioned ("Summary of Safety and Effectiveness") refers to the overall documentation supporting the 510(k) submission, not a specific clinical trial with a test set of patient data for performance validation.
- Data Provenance: Not applicable for the same reasons. There's no clinical "data" in the sense of patient records or imagery evaluated by an algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts/Qualifications: Not applicable. This document is not about establishing ground truth for a test set of data. It's a regulatory submission for a physical device.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" of data requiring expert adjudication 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
- MRMC Study / AI Assistance: Not applicable. This document pertains to a physical spinal implant. There is no mention or implication of AI, software, or human reader assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is not an AI/algorithm device.
7. The Type of Ground Truth Used
- Type of Ground Truth: In the context of a 510(k) for a physical device like this, the "ground truth" for demonstrating substantial equivalence is based on:
- Predicate Device's Established Safety and Effectiveness: The primary "ground truth" is that the previously cleared predicate device (versions of the CD HORIZON® system itself) is already deemed safe and effective for its indicated uses.
- Bench Testing/Engineering Standards (Implied): While not detailed in this summary, the safety and performance of the physical components (e.g., strength, fatigue, biocompatibility) would be evaluated against established engineering standards and specifications.
- Clinical Experience (Implied): The indications for use are based on established clinical practices for spinal surgery.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. No training set is involved.
In Summary:
The provided document is a regulatory approval document (510(k)) for a physical medical device, the CD HORIZON® Spinal System. It demonstrates "substantial equivalence" of newer versions and components to previously cleared versions of the same system. The concepts of "acceptance criteria" and "studies" as typically applied to AI/software performance (e.g., sensitivity, specificity, test/training sets, expert adjudication) are not relevant here. The "study" referenced in the title "Summary of Safety and Effectiveness" refers to the entire body of evidence and documentation presented for the 510(k) submission to the FDA, not a clinical trial evaluating novel performance metrics.
§ 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.