(232 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, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPIRE Plate is a 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: 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); and/or tumor.
The CD HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, are indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw system in skeletally mature patients, the CD HORIZON® Spinal System PEEK rods and associated components are intended to provided immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: (1) are receiving fusion with autogenous graft only, (2) are having the device attached to the lumbar or sacral spine, and/or (3) are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system in skeletally mature patients, the CD HORIZON® AGILE™ Dynamic Stabilization Device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the degenerative spondylolisthesis with objective evidence of neurologic impairment and/or failed previous fusion in the thoracic, lumbar and/or sacral spine. Additionally, when used as a pedicle screw fixation system, the CD HORIZON® AGILE™ Dynamic Stabilization Device is indicated for use in patients who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and/or are having the device removed after the development of a solid fusion mass.
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 the CD HORIZON® AGILE™ Dynamic Stabilization Device to the CD HORIZON® Spinal System.
The provided document is a 510(k) summary for the CD HORIZON® Spinal System, specifically focusing on the inclusion of the CD HORIZON® AGILE™ Dynamic Stabilization Device. This type of submission generally demonstrates substantial equivalence to a legally marketed predicate device rather than presenting a study to prove the device meets specific acceptance criteria in the manner of a clinical trial for a novel AI/software product.
Therefore, many of the requested categories for AI/software product evaluation (such as sample size for test/training, number of experts, adjudication methods, MRMC studies, or standalone performance for an algorithm) are not applicable to this type of medical device submission.
Here's an analysis based on the information provided, tailored to the context of a 510(k) for a spinal implant system:
1. Table of Acceptance Criteria and Reported Device Performance
For this mechanical device, "acceptance criteria" typically refer to successful completion of mechanical and perhaps other engineering tests demonstrating safety and performance comparable to predicate devices. The document states that mechanical test results were provided to demonstrate substantial equivalence. Specific acceptance criteria (e.g., minimum bending strength, fatigue life) and their corresponding performance values are generally not detailed in a public 510(k) summary but would be part of the full submission to the FDA. The "reported device performance" is implicitly that it passed these mechanical tests, allowing it to be deemed substantially equivalent.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Testing | Demonstrated substantial equivalence to predicate devices through mechanical test results. Specific test parameters (e.g., strength, fatigue, motion) were performed to show comparable performance for the CD HORIZON® AGILE™ Dynamic Stabilization Device to its predicates. |
| Biocompatibility | (Not explicitly stated in this summary, but would be an implicit requirement for implantable devices – assumed to be met if predicates are cleared.) |
| Sterilization | (Not explicitly stated, but assumed to be met for implantable devices.) |
| Design Specifications | Met design specifications making it compatible with the CD HORIZON® Spinal System and functionally similar to predicate dynamic stabilization systems. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) for a mechanical device. Mechanical testing involves specific test fixtures and a defined number of samples for each test type (e.g., fatigue, static bending), which are typically fewer than a clinical trial's "sample size." This information is not detailed in the summary.
- Data Provenance: The mechanical tests would have been performed in a laboratory, likely by or for the manufacturer (Medtronic Sofamor Danek, Inc., USA). The data is from retrospective engineering tests, not prospective human data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not relevant for the type of mechanical testing conducted for a 510(k) submission of a spinal implant. The "truth" for mechanical tests is defined by engineering standards and measurements.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments. For mechanical testing, results are quantitative and derived from standard test methods.
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 is a spinal implant system, not an AI or software device involving human readers or interpretation of medical data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a spinal implant system, not an algorithm or AI device.
7. The Type of Ground Truth Used
- For mechanical testing, the "ground truth" is defined by established engineering principles, material properties, and standardized test methods (e.g., ASTM standards for spinal implants) that determine the device's physical performance characteristics (strength, fatigue life, stiffness, motion profile).
8. The Sample Size for the Training Set
- Not applicable. There is no AI model or algorithm being "trained" in this submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no AI model or algorithm being "trained" in this submission.
Summary in the Context of a 510(k) for a Spinal Implant:
The document primarily focuses on demonstrating Substantial Equivalence to legally marketed predicate devices. For a mechanical device like the CD HORIZON® Spinal System, this is typically achieved by:
- Similarities in Indications for Use: The submitted device's indications are compared to predicates.
- Similarities in Technological Characteristics: Design, materials, and functional principles are compared.
- Performance Data: This is where "acceptance criteria" and "testing" come in. The submission states, "Documentation, including mechanical test results, was provided which demonstrated the subject CD HORIZON® AGILE™ Dynamic Stabilization Device to be substantially equivalent to predicate CD HORIZON® Spinal System (K042025, SE 08/25/04), the ATLAS Cable System (K920291, SE 04/08/92), and the DYNESYS® Spinal System cleared in K043565 (SE 03/11/05)."
The acceptance criteria are therefore implicit in the regulatory requirement for substantial equivalence, meaning the device must perform comparably to its predicates in relevant mechanical and material safety tests. The "study" proving this consisted of these mechanical tests, not a clinical trial or AI performance evaluation.
§ 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.