(133 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 turnor 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 (T1-SI) 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. These components can be rigidly locked into a verity of configurations, with each construct being tailor made for the individual case.
A subset of the 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, Crosslinks® 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 components to the system, specifically, Side Loading (SILO) and Closed SOLERA™ lateral connectors.
This 510(k) summary for the CD HORIZON® Spinal System describes a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria (e.g., acceptance criteria for algorithmic performance, sample sizes for training/test sets, ground truth establishment methods, expert qualifications, MRMC studies, standalone performance) are not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices, which is the standard for 510(k) clearances for traditional medical devices. This means the new device (CD HORIZON® Spinal System with added components) is as safe and effective as a legally marketed device.
Here's an analysis based on the provided text, highlighting the differences in evaluation for medical devices versus AI/ML:
Acceptance Criteria and Study for CD HORIZON® Spinal System
1. Table of Acceptance Criteria and Reported Device Performance
For traditional medical devices like the CD HORIZON® Spinal System, "acceptance criteria" are not typically expressed as numerical performance metrics (like sensitivity/specificity for an algorithm). Instead, the primary acceptance criterion for 510(k) clearance is substantial equivalence to predicate devices. This is demonstrated by showing:
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance (as per document) |
|---|---|
| Similar Indications for Use | The CD HORIZON® Spinal System's stated Indications for Use (posterior, non-cervical fixation as an adjunct to fusion for various conditions in adult and pediatric patients) are consistent with those of the predicate CD HORIZON® Spinal System and its components. |
| Similar Technological Characteristics | The subject lateral connectors are manufactured in Titanium Alloy, provided in Side Loading (SILO) and Closed rod interconnection, and used to connect rods to screws to minimize rod bending. Their sizes are within the range of predicate lateral connectors. The subject set screw is identical in design, material, and fundamental scientific technology to the predicate set screw, with only an additional sterilization method as a modification. |
| Similar Materials | The subject lateral connectors are Titanium Alloy, similar to the predicate. The set screw materials are identical to the predicate. |
| Similar Design Principles | The components can be rigidly locked into various configurations, tailor-made for individual cases, reflecting the same fundamental scientific technology as the predicate system. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable: This typically refers to data used to evaluate an algorithm's performance. For a physical spinal implant system, there isn't a "test set" of data in this context. The evaluation is based on engineering design, material properties, mechanical testing (which is implied to support the "similar technological characteristics" claim), and comparison to predicate devices, not on data samples in the sense of AI/ML evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable: "Ground truth" for an implant system is established through a combination of engineering standards, clinical consensus, and regulatory requirements, not typically by expert review of a "test set" of cases in the way an AI algorithm's output would be adjudicated. Clinical studies for implants, if conducted, would involve surgeons, but the primary evidence for a 510(k) for this type of device is substantial equivalence.
4. Adjudication Method for the Test Set
- Not Applicable: No "test set" or adjudication method in the AI/ML sense is mentioned or relevant for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: MRMC studies are used to evaluate diagnostic or screening performance, often in imaging, and are not relevant for demonstrating the substantial equivalence of a spinal fixation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable: This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- For the purposes of this 510(k) submission, the "ground truth" implicitly refers to the established safety and effectiveness of the predicate devices and the adherence of the subject device to relevant engineering and biocompatibility standards. The submission asserts that the subject device's characteristics (design, materials, indications for use) are sufficiently similar to those of the predicate devices such that it can be considered equally safe and effective.
8. The Sample Size for the Training Set
- Not Applicable: This refers to data used to train an algorithm. For a physical medical device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: See point 8.
Summary of Device Acceptance (510(k) Clearance)
The acceptance of the CD HORIZON® Spinal System referenced in this document is based on the FDA's determination of substantial equivalence to legally marketed predicate devices. The "study" proving this is implicitly the rigorous comparison of the new components (Side Loading (SILO) and Closed SOLERA™ lateral connectors, and modifications to the set screw) against the existing components and predicate systems. This comparison showed that the subject device:
- Has the same fundamental scientific technology.
- Utilizes similar materials (Titanium Alloy) and has an identical design for the set screw (with an additional sterilization method).
- Maintains similar indications for use as established for the predicate CD HORIZON® Spinal System.
The FDA reviewed this evidence and concluded that the device is substantially equivalent to the predicates, thus allowing it to be marketed.
§ 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.