(28 days)
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to 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, or lordosis), tumor, pseudarthrosis, 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 as an adjunct to fusion.
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 as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation 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 shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailor-made for the individual case.
A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this submission is to modify Medtronic's CD HORIZON® Spinal System to add additional components to the system, specifically non-sterile 30° and 45° Transverse Hooks.
The provided document is a 510(k) premarket notification for the Medtronic CD HORIZON® Spinal System, specifically for the addition of new 30° and 45° Transverse Hooks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than rigorously proving the device meets acceptance criteria through extensive clinical studies as one might find for novel device approvals.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader multi-case studies is largely not applicable nor present in this document, as the submission method (510(k)) and the nature of the device (an modification to an existing spinal system component) do not typically require such detailed clinical performance data.
However, I can extract the information that is present concerning the demonstration of substantial equivalence which serves the purpose of regulatory acceptance for this type of device.
Here's the closest interpretation of your requests based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" primarily refers to demonstrating equivalent technological characteristics and performance compared to existing predicate devices, rather than predefined clinical performance metrics. The "reported device performance" is framed in terms of this equivalence.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (vs. Predicate) |
|---|---|
| Intended Use | The subject hooks (30° and 45° Transverse Hooks) have the same intended use as the predicate devices. (Page 5, Section V; Page 7, Section VI) |
| Indications for Use | The subject hooks have the same indications for use as the predicate devices: posterior, non-cervical fixation as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and/or failed previous fusion. (Page 5, Section V; Page 7, Section VI) |
| Material | The subject transverse hooks are manufactured from the same material (titanium alloy - Ti-6Al-4V ELI) as the predicates. This material has a long history of safe and effective use. (Page 7, Section VII) |
| Fundamental Scientific Technology | The subject and predicate hooks are based on the same fundamental scientific technology of providing posterior, non-cervical fixation, connecting to 5.5mm/6.0mm rods in the T1-S1 region, and being secured with set screws. The only difference is a transition offset that "does not raise any issues of safety and effectiveness." (Page 7, Section VI) |
| Sterilization Method | The subject hooks use the same sterilization method as the predicate devices. (Page 5, Section V; Page 7, Section VI) |
| Mechanical Performance (Safety/Effectiveness) | Medtronic evaluated the subject transverse hooks through an engineering rationale and a risk analysis. Both evaluations demonstrated that the subject hooks do not introduce a new worst case to the CD HORIZON® Spinal System. Therefore, no new mechanical testing was required because existing tests on the predicate devices are considered sufficient to demonstrate equivalence for the modified components. (Page 7, Section VII) (No specific performance values are given, only a qualitative assessment of non-inferiority/equivalence through engineering rationale.) |
| Biocompatibility | Due to the use of the same implant material (Ti-6Al-4V ELI) that has a long history of safe and effective use in similar spinal implants, no additional biocompatibility testing was required. (Page 7, Section VII) |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not applicable/Not provided in the context of this 510(k) submission. No clinical "test set" in the traditional sense was used. The evaluation was primarily based on engineering rationale, risk analysis, and comparison to existing mechanical testing data from predicate devices.
- Data provenance: Not applicable/Not provided. The data is internal engineering and risk analysis documentation from Medtronic Sofamor Danek USA, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" was established by experts in the context of clinical data for this type of submission. The safety and effectiveness are established through demonstrating substantial equivalence to predicate devices, supported by internal engineering/risk assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical "test set" requiring adjudication.
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 device is a mechanical spinal implant component, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a mechanical spinal implant component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" equivalent in a 510(k) for a device component like this is the established safety and effectiveness of the predicate devices and the physical/mechanical properties of the materials and design, confirmed through engineering rationale and risk analysis. The regulatory acceptance depends on demonstrating that the new components are equally safe and effective as the predicates.
8. The sample size for the training set
Not applicable/Not provided. There was no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. There was no "training set" or "ground truth" in this context.
§ 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.