(16 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); turnor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/Jumbar 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 (TI-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 510(k) was to add additional components to the system, namely 5.5mm diameter SOLERA™ LONGITUDE® rods manufactured out of titanium alloy and modified LONGITUDE® II instruments.
This document describes a 510(k) premarket notification for the CD HORIZON® Spinal System, which is a medical device for spinal fixation. The notification focuses on adding new components to an existing system. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance of the new components demonstrating substantial equivalence to predicate devices, rather than a clinical study establishing diagnostic performance of an AI model.
Here's the information extracted from the provided text, structured to address your points as best as possible given the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Not specified, but implied to be related to the performance of predicate devices. | "For all test methods, the subject devices met the pre-determined acceptance criteria." |
| Functionality | Not specified, but implied to be related to the intended function of the instruments. | "Tolerance stacks and validation labs were completed to verify and validate that the subject LONGITUDE® II instruments function as intended and meet the pre-determined customer needs." |
| Material Equivalence | Material (titanium alloy) for rods must be equivalent to previously cleared materials. | "Non-clinical testing in the form of mechanical testing was not required for the subject LONGITUDE® rods since the only difference between them and the predicate rods was the material, which has previously been cleared in the CD HORIZON® Spinal System." |
| Substantial Equivalence | Demonstrated substantial equivalence to identified predicate devices in design features, materials, and indications for use. | "Based on the test results and additional supporting documentation provided in this pre-market notification, the subject devices demonstrated substantial equivalence to the previously listed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a mechanical medical device component and the "test set" refers to mechanical testing or validation processes for the device itself, not a dataset for an AI algorithm. The document states that "non-clinical mechanical testing was performed in accordance with ASTM F1798." No specific sample sizes for tests (e.g., number of rods tested) or data provenance (e.g., country of origin) are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This is not applicable. "Ground truth" in the context of an AI device refers to a definitively correct label or outcome for data used in performance evaluation, typically established by human experts or pathology. For a mechanical device, performance is evaluated against engineering standards and functional requirements.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving expert interpretation, often for establishing ground truth for AI algorithms. This document describes mechanical and functional testing, not expert interpretation of data.
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
This is not applicable. This is not an AI device, and therefore no MRMC study or comparative effectiveness study involving AI assistance would have been conducted or reported here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This document pertains to a physical medical device (spinal system components), not an algorithm or AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This is not applicable in the typical sense for AI. For a mechanical device, "ground truth" would be the engineering specifications, functional requirements, and established performance characteristics of predicate devices. The "truth" is that the new components perform equivalently to the existing, cleared components.
8. The Sample Size for the Training Set
This is not applicable. As this is not an AI device, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable. As this is not an AI device, there is no "training set" or ground truth established in that 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.