(70 days)
The CD HORIZON® Spinal System 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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are 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, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) turnor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); 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 ocaling a larena, "mal 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 include additional components to the CD HORIZON® Spinal System.
This document is a 510(k) premarket notification for the CD HORIZON® Spinal System. It seeks clearance for additional components to an existing device. As such, it does not contain a study demonstrating device performance against specific acceptance criteria in the way a clinical trial for a novel AI device would.
Instead, the primary "acceptance criterion" for this type of submission is substantial equivalence to previously cleared predicate devices. The study proving this involves a comparison of the new components to these predicates.
Here's a breakdown based on the provided text, addressing your questions to the best extent possible within the context of a 510(k) for device components:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 510(k) Process) | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence: The new device components must be as safe and effective as a legally marketed device (predicate device) that is not subject to premarket approval (PMA). This is assessed by comparing indications for use, technological characteristics, and performance data if applicable. | Documentation provided which demonstrated the CD HORIZON® Spinal System to be "substantially equivalent to CD HORIZON® Spinal System components previously cleared in K981676 and K031655." The FDA concurred with this determination. |
| Intended Use and Indications: The device's intended use and indications must be similar to or the same as the predicate device, or if different, the new indications must not raise new questions of safety and effectiveness. | The "Indications for Use" for the additional components are detailed and align with the existing indications for the CD HORIZON® Spinal System and, by extension, are considered similar to the predicate devices. These indications cover various spinal conditions like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and failed previous fusion. |
| Technological Characteristics: The technological characteristics of the new device components must be substantially equivalent to the predicate device, or any differences must not raise new questions of safety and effectiveness. | The document implicitly asserts the technological characteristics of the additional components are similar enough to existing cleared components (K981676 and K031655) to maintain substantial equivalence. The submission adds "side-loading screws, hooks, and connectors" to the system. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a 510(k) for device components based on substantial equivalence. This type of submission relies on comparative data to predicate devices rather than a de novo clinical "test set" with patients or a specific product performance study against a statistical target.
- Data Provenance: The "data" proving substantial equivalence is primarily comparative analysis of the new components against the existing predicate devices (CD HORIZON® Spinal System components cleared under K981676 and K031655). No specific country of origin or retrospective/prospective nature is mentioned for this comparative documentation, as it's not a clinical study in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. As this is a 510(k) for showing substantial equivalence of device components to existing cleared devices, there isn't a "ground truth" establishment process by external experts on a test set in the way an AI algorithm or diagnostic device would undergo. The FDA reviewers are the "experts" who evaluate the submission against regulatory requirements.
4. Adjudication Method for the Test Set
- Not applicable. There is no "test set" or external adjudication in the context of this 510(k) summary. The FDA's review process functions as the adjudication, determining whether the provided documentation sufficiently demonstrates substantial equivalence.
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
- No. This document describes a mechanical spinal implant system, not an AI or diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device (spinal implant components), not an algorithm or software. "Standalone" performance as an algorithm is not relevant.
7. The Type of Ground Truth Used
- Not applicable in the conventional sense. For a 510(k) of device components seeking substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices as determined by their previous clearance. The manufacturer asserts that the new components are equivalent to these known predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This submission is for physical device components, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for a machine learning model, this question is not relevant to the provided text.
§ 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.