(37 days)
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX Reconstruction System is indicated 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.
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/Connectors
The use of multi-axial screws are 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.
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. 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, 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.
This document is a 510(k) summary for the VERTEX® Reconstruction System, a spinal interlaminal fixation orthosis. It's a regulatory submission affirming substantial equivalence to previously cleared devices, not a study reporting on the device's performance in detail against specific acceptance criteria. Therefore, the information requested about acceptance criteria and study details for device performance is largely not present in this document.
However, based on the context of a 510(k) submission for a spinal implant, we can infer some general aspects.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria nor does it report specific device performance data in a quantitative manner as typically found in clinical studies or performance testing reports. This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices, which implies that the new device meets the same safety and effectiveness standards as the predicate devices.
The "PERFORMANCE DATA" section states:
- "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*": "N/A" for characteristic, standard/test/FDA guidance, and results summary.
- "Comparative Performance Information Summary": "N/A" for characteristic, requirement, new device, and predicate device.
- "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION": "Not Applicable"
- "CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA": "Not Applicable; the system did not change. The surgical techniques were only updated to provide more detail. The overall implant process did not change."
This explicitly states that no new performance data (clinical or non-clinical) was generated or submitted for this particular 510(k). The purpose of this submission was to consolidate several cleared surgical techniques into two concise documents, implying that the device itself, and its performance characteristics, are considered unchanged from previously cleared versions.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
As indicated above, there was no new test set used for a performance study described in this 510(k) submission. Therefore, information regarding sample size, data provenance, retrospective/prospective nature, or country of origin is not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since there was no new test set or clinical study conducted, there's no information on experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new test set or study was performed.
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 submission for a spinal implant system, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis would be part of this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new performance study generating ground truth was described.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device.
Summary of what can be inferred from the document:
The VERTEXT® Reconstruction System is a spinal implant system. This 510(k) submission (K110522) by Medtronic Sofamor Danek USA, Inc. primarily served to:
- Consolidate existing surgical techniques for the device into updated documentation.
- Affirm that the device itself and its indications for use remain substantially equivalent to previously cleared predicate devices (listed in the document, e.g., K003780, K062447, etc.).
The "study" that proves the device meets acceptance criteria referred to by the applicant (Medtronic) is the accumulated body of evidence and prior clearances for the predicate devices and earlier versions of the VERTEX® Reconstruction System. This 510(k) is essentially a declaration that the changes (consolidation of surgical techniques) do not alter the substantial equivalence to those previously cleared devices, and therefore, no new performance data or clinical studies were deemed necessary by the FDA.
§ 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.