(103 days)
When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors.
Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Multi-axial Screws
The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine. Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
Connectors
In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.
The VERTEX SELECT® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations. The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol -- NiTi). Shape Memory Alloy is compatible with titanium alloy, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel. To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopaedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.
Here's an analysis of the provided text regarding the VERTEX® Reconstruction System's acceptance criteria and study information:
Acceptance Criteria and Device Performance
This 510(k) submission for the VERTEX® Reconstruction System is for the addition of new components to an already cleared device. Therefore, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to the existing predicate devices rather than establishing novel performance metrics against a clinical standard.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Material Equivalence | Identical materials to predicate device. | The subject and predicate parts are identical in terms of material. | The system is fabricated from medical grade titanium, titanium alloy, and cobalt chromium. The retaining ring uses Shape Memory Alloy (Nitinol - NiTi), and some components have silicone adhesive elastomeric stakes. |
| Indications for Use Equivalence | Identical indications for use to predicate device. | The subject and predicate parts are identical in terms of... indications for use. | The indications for use are clearly stated for the occipitocervical, cervical, and thoracic spine (Occiput-T3) for conditions like DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors. |
| Intended Use Equivalence | Identical intended use to predicate device. | The subject and predicate parts are identical in terms of... intended use. | The system is a posterior system providing stabilization to promote fusion. |
| Performance Specifications Equivalence | Identical performance specifications to predicate device. | The subject and predicate parts are identical in terms of... performance specifications. | This implies the new components maintain the same mechanical performance characteristics as the existing system. |
| Mechanical Performance (New Components) | Withstand expected physiological loads; meet ASTM F1717-12 standards for compression fatigue, static compression, and static torsion. | Medtronic performed compression fatigue, static compression, and static torsion on the subject connectors in accordance with ASTM 1717-12. Non-clinical testing... demonstrated substantial equivalence of the subject devices to the predicate devices. | The study confirms the new connectors meet the relevant ASTM standards, thereby maintaining mechanical performance equivalence. |
| Design Features | Differences (length, angled open connection) do not negatively impact substantial equivalence. | Key differences: length and the addition of an angled open connection option. These differences were evaluated through non-clinical testing to show equivalence. | The design changes were assessed to ensure they did not introduce new safety or effectiveness concerns. |
Summary of the Study:
The study conducted was a non-clinical design verification and validation activity specifically aimed at demonstrating substantial equivalence of the new components (lengths and an angled open connection option) to the previously cleared predicate devices.
Specific Information Requested:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated in the provided text. The text mentions "non-clinical testing" was performed on "the subject connectors." For mechanical tests like those mentioned (compression fatigue, static compression, static torsion), specific sample sizes would typically be defined per test in the ASTM standard (ASTM F1717-12). However, the exact number of components tested is not provided.
- Data Provenance: Not applicable in the context of this 510(k). This was a non-clinical, bench-top mechanical testing study, not a clinical trial involving human patient data. Therefore, there's no country of origin or retrospective/prospective distinction for data collection in the sense of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical, mechanical testing submission. "Ground truth" in this context refers to the defined mechanical properties and performance standards (e.g., tensile strength, fatigue life) which are established by engineering specifications and industry standards (like ASTM F1717-12), not by expert medical opinion on a dataset.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of imaging or clinical outcomes by multiple experts. This 510(k) describes mechanical bench testing, where performance is measured objectively against predefined engineering specifications.
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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:
- No. This device is a surgical implant (spinal reconstruction system), not an AI-powered diagnostic or imaging interpretation tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is entirely irrelevant and was not conducted.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is not an algorithm. It is a physical medical implant. Therefore, standalone algorithm performance is not applicable.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this submission's non-clinical testing was based on engineering specifications and compliance with recognized industry standards (ASTM F1717-12). The goal was to show that the new components met the same mechanical performance requirements as the predicate devices.
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The sample size for the training set:
- Not applicable. This submission describes mechanical testing for a physical implant, not a machine learning model. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for a machine learning model, this question is not relevant.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.