(28 days)
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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.
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® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. 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 (F1-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 system also includes various instruments used to assist in the implantation of the system via minimally invasive approaches.
The purpose of this submission is to modify Medtronic's CD HORIZON® Spinal System to add additional lined rods to the system, specifically, 5.5mm and 6.0mm lined rods in cobalt chrome, and a 6.35mm lined rod in titanium alloy.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CD HORIZON® Spinal System, structured according to your request:
It's important to preface this by stating that this document is a 510(k) summary for a spinal implant system, not a medical device that generates data (like an AI algorithm or diagnostic tool). Therefore, many of the requested points, particularly those related to machine learning studies (e.g., test sets, ground truth establishment, expert consensus, MRMC studies), are not applicable to this type of submission. This document focuses on the mechanical and material properties of the device and its substantial equivalence to previously cleared devices.
Acceptance Criteria and Device Performance Study for CD HORIZON® Spinal System (K131321)
This 510(k) pertains to a modification of an existing spinal system, specifically the addition of new sizes of lined rods. The "acceptance criteria" here are primarily based on the demonstration that these new components do not introduce new risks and maintain the fundamental scientific technology and performance characteristics of the predicate devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety - Absence of New Risks | No new risks are introduced by the additional lined rods. | "Verification and validation activities demonstrated that no new risks have been introduced..." |
| Performance - Worst Case Scenario | The addition of lined rods does not create a new worst-case scenario for the overall system. | "...and that the addition of the subject lined rods does not create a new worst case for the overall CD HORIZON® Spinal System." |
| Material Equivalence | New rods are manufactured from same biocompatible materials as predicate. | New rods manufactured from "same cobalt chromium alloy per ASTM F1537 and titanium alloy per ASTM F136 as the predicate rods." |
| Dimensional & Design Equivalenc | New rods have similar fundamental scientific technology, dimensions (diameter, length) to predicate. | New rods have "the same fundamental scientific technology," are "5.5mm, 6.0mm and 6.35mm in diameter, and are 500-700mm in length." The lining is a "visual aid." |
| Substantial Equivalence | The modified device is substantially equivalent to legally marketed predicate devices. | "Medtronic believes the subject CD HORIZON® Spinal System, including the subject lined rods, to be substantially equivalent to legally marketed predicate devices..." (FDA concurs with this finding in the closing statement). |
2. Sample size used for the test set and the data provenance
- Not applicable. This submission is for mechanical components, not an algorithm or diagnostic device tested on clinical data. The "test set" here refers to components undergoing non-clinical (e.g., mechanical, materials) testing, not a patient dataset.
- The document implies that testing was conducted on manufactured components, but does not specify the sample size of tested rods, nor does it refer to "countries of origin of data" or "retrospective/prospective" studies in a clinical data sense. The provenance of the testing data would be internal Medtronic labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. "Ground truth" in the context of expert consensus on diagnostic images or clinical outcomes is not relevant here. The "ground truth" for this device would be established engineering standards, material specifications (e.g., ASTM standards), and established biomechanical performance metrics for spinal implants. Expertise would come from engineers, materials scientists, and quality assurance personnel involved in device design and testing, not clinical experts establishing a ground truth from patient data.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like "2+1" or "3+1" are used for resolving discrepancies in expert interpretations of clinical data or image annotations. This is not performed for mechanical device testing. Compliance with engineering standards and specifications would be internally verified and validated.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, how much human readers improve with AI vs without AI assistance.
- Not applicable. This is a hardware implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are completely irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- Not applicable. This is a hardware implant. There is no algorithm or standalone performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device, the "ground truth" relies on engineering specifications, material science standards (e.g., ASTM F1537 for cobalt chromium, ASTM F136 for titanium alloy), and biomechanical testing standards. The goal is to demonstrate that the new components meet these established engineering criteria and perform comparably to predicate devices in terms of mechanical integrity, fatigue strength, and biocompatibility.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not a machine learning model.
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 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.