(113 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, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPINOUS PROCESS 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: degencrative 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 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.
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 an alternative stainless steel material to the CD HORIZON® Spinal System.
This document is a 510(k) summary for the CD HORIZON® Spinal System, which is a medical device. 510(k) submissions aim to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its effectiveness through new clinical studies in the same way a drug or novel device might.
Therefore, the acceptance criteria in this context are not based on performance metrics like sensitivity, specificity, or accuracy, but rather on demonstrating substantial equivalence to an existing device. The "study that proves the device meets the acceptance criteria" is the 510(k) submission itself, which compiles information to show this equivalence.
Here's an analysis based on the provided text, while noting that many of your requested items (like sample size for test/training sets, experts for ground truth, MRMC study details) are typically not applicable to a 510(k) submission for substantial equivalence of a modified or existing device:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for 510(k) Substantial Equivalence:
The primary acceptance criterion for a 510(k) submission is to demonstrate that the new device (CD HORIZON® Spinal System with alternative stainless steel material) is substantially equivalent to a legally marketed predicate device in terms of:
- Intended use
- Technological characteristics
- Safety and effectiveness
Reported Device Performance (as described in the 510(k) context):
| Acceptance Criterion (for 510(k) equivalence) | Reported Device Performance (as demonstrated by the submission) |
|---|---|
| Intended Use Equivalence | The intended uses for the CD HORIZON® Spinal System (posterior, non-cervical fixation for various spinal conditions) remain identical to the predicate device. The submission focuses on including an alternative stainless steel material, not changing the indications. |
| Technological Characteristics Equivalence | The device's components (rods, hooks, screws, plates, etc.) and their function remain the same. The change is the material of certain components (inclusion of an alternative stainless steel), which implies that the material properties (e.g., mechanical strength, biocompatibility) are equivalent or superior to the existing material for the stated applications. |
| Safety and Effectiveness Equivalence | The submission asserts that the device is substantially equivalent in safety and effectiveness to the existing CD HORIZON® Spinal System. This is typically supported by referencing existing clinical data for the predicate device, mechanical testing of the new material, and biocompatibility assessments. |
| Compliance with Regulations | The device is classified under 21 CFR 888.3070, 888.3060, 888.3050 (Pedicle Screw Spinal System, Spinal Intervertebral Body Fixation Orthosis, Spinal Interlaminal Fixation Orthosis) and is subject to Class II Special Controls. The FDA's letter states that "FDA's issuance of a substantial equivalence determination... permits your device to proceed to the market," implying compliance. |
2. Sample Size for Test Set and Data Provenance
- Not Applicable / Not Provided for this type of submission. A 510(k) for substantial equivalence of a spinal fixation system, especially when adding a new material, typically relies on mechanical testing, biocompatibility testing, and comparison to existing clinical data for the predicate device, rather than a prospective clinical trial with a "test set" in the sense of a diagnostic algorithm.
- The document states: "Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to itself." This phrase implies that the submission is essentially an update or modification to an already approved device, rather than a completely new one requiring new large-scale human clinical data for the "test set." The data provenance would be a combination of internal testing data and existing clinical literature/data for the original device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable / Not Provided. This type of information is relevant for studies involving human interpretation or subjective assessments, like image analysis algorithms. For a spinal implant, ground truth is established through mechanical testing standards, material science specifications, and clinical outcomes for the predicate device documented in medical literature.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1) are typically used for consensus building on subjective assessments for ground truth in clinical trials or diagnostic studies. This is not applicable to a 510(k) for a spinal implant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is used to assess the performance of diagnostic readers (e.g., radiologists) with and without the assistance of an AI tool. This is not relevant to a spinal implant system like the CD HORIZON®.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. The CD HORIZON® Spinal System is a physical implant, not a software algorithm. Therefore, "standalone performance" in this context is expressed through its mechanical and biological properties, not computational output.
7. The Type of Ground Truth Used
- For this device, the "ground truth" would be established through a combination of:
- Mechanical Testing: Demonstrating that the alternative stainless steel material meets or exceeds established mechanical strength, fatigue, and torsional resistance standards for spinal implants. (Though details of these tests are not provided in this specific summary).
- Biocompatibility Testing: Ensuring the new material is safe for implantation in the human body.
- Clinical Outcomes Data (from predicate): The existing safety and effectiveness profile of the original CD HORIZON® Spinal System (the predicate device itself) serves as the benchmark. The modified device is expected to perform equivalently.
- Regulatory Standards: Compliance with relevant ASTM or ISO standards for medical implants.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided. This term is used in machine learning. For a physical medical device, "training set" is not a relevant concept in the same way. The development process involves engineering, material science, and testing, not algorithmic training data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable / Not Provided. As "training set" doesn't apply, neither does establishing its ground truth in this context.
In summary: The provided document is a 510(k) Premarket Notification. The "acceptance criteria" here refer to meeting the legal standard of "substantial equivalence" to a predicate device, which allows the modified device to be marketed. This process primarily relies on demonstrating equivalent intended use, technological characteristics (including material properties and performance in mechanical tests), and safety/effectiveness, rather than conducting new large-scale clinical trials with human subjects and AI algorithms.
§ 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.