(87 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/umbar 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 treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric 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. The subject devices include: Rods Extenders Sequential Reducer Inserters Modified Labeling (surgical techniques and disassembly/assembly instructions) Accessories, cases, caddies, trays, and lids which may be used to transport and sterilize the subject implants and instruments. The subject CD HORIZON® Spinal System devices will be available in similar sizes as the predicate systems.
The provided text describes specific details about a medical device (CD HORIZON® Spinal System) and its regulatory approval process, focusing on substantial equivalence to predicate devices, rather than an AI/ML device or its associated studies for performance. Therefore, I cannot extract the information requested for a device that uses AI/ML.
However, I can provide a summary based on the information available about the CD HORIZON® Spinal System's performance validation from pages 4 and 5 of the document, which pertains to medical device testing for substantial equivalence, not AI/ML performance.
Acceptance Criteria and Study for CD HORIZON® Spinal System (Non-AI/ML Device)
The provided document details the substantial equivalence review for the CD HORIZON® Spinal System, a non-AI/ML device. The "study" mentioned refers to engineering rationales and bench testing conducted to demonstrate that the new device is as safe and effective as previously approved predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|---|
| Biocompatibility | Biological Evaluation (ISO-10993 Part 1) | Materials must be safe for body contact based on contact duration and type. | Subject rods are manufactured from identical materials (Cobalt-28-Chromium-6-Molybdenum, Titanium-6 Aluminum-4 Vanadium ELI) as predicate devices, adhering to ASTM standards. Biocompatibility testing was not required as these materials have a long history of safe and effective use. |
| Instrument Biocompatibility | External communicating instruments (extenders, reducers, inserters) and their materials must be safe for limited body contact. | Instruments are manufactured from medical grade stainless steel (ASTM F899, A564, A693, A276) and acetal (ASTM F1855) which have a long history of safe and effective use. Biocompatibility testing was not required. | |
| Mechanical Testing | Static Reduction Testing | Performance must meet predetermined acceptance criteria based on ASTM F1717 standards. | The tests met the predetermined acceptance criteria. |
| Cantilever Load Testing | Performance must meet predetermined acceptance criteria. | The tests met the predetermined acceptance criteria. | |
| Torsional Load Testing | Performance must meet predetermined acceptance criteria. | The tests met the predetermined acceptance criteria. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Mechanical Testing: Sample size was determined based on ASTM F1717 for Static Reduction Testing. Specific numerical sample sizes are not provided in this document.
- Data Provenance: The studies were bench tests conducted by Medtronic Sofamor Danek USA, Inc. The data is generated internally to support a 510(k) submission, therefore it is prospective in nature with respect to the regulatory submission, but the tests simulate conditions. There is no information about country of origin of data as it's not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document is about a hardware medical device and its mechanical/biocompatibility testing for substantial equivalence, not an AI/ML device requiring expert ground truth for diagnostic or prognostic purposes. The "ground truth" for mechanical tests is established by published ASTM standards.
4. Adjudication Method for the Test Set
This information is not applicable for the type of testing described (mechanical and biocompatibility bench testing). Adjudication typically refers to expert review of clinical cases. The fulfillment of acceptance criteria for bench tests is usually objective and measurable, not subject to adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The device is a spinal implant system, not an imaging or diagnostic AI/ML tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or detailed.
6. Standalone (Algorithm Only) Performance
This information is not applicable as the device is a spinal implant system and does not involve an algorithm.
7. Type of Ground Truth Used
- For Biocompatibility: The "ground truth" is established by adherence to recognized standards (ISO-10993) and the long history of safe and effective use of the materials (Cobalt Chrome, Titanium, Stainless Steel, Acetal) in spinal surgery, eliminating the need for novel biocompatibility testing.
- For Mechanical Testing: The "ground truth" or reference for acceptable performance is established by ASTM F1717 and other relevant ASTM standards for materials and mechanical properties of spinal implants.
8. Sample Size for the Training Set
This information is not applicable as there is no AI/ML algorithm or training set involved in the development or testing of this hardware device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no AI/ML algorithm or training set involved.
§ 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.