(76 days)
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-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.
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.
Screws/Connectors
The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. 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.
The VERTEX™ Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of 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 tailormade for the individual case. Titanium ATLAS™ cable may be used with this system at the surgeon's discretion.
The VERTEX™ Reconstruction System is fabricated from medical grade titanium or titanium allov. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel.
The purpose of this submission was to add components to the system including a threaded rod, lateral connectors and modified screws.
The provided text is a 510(k) summary for the VERTEX™ Reconstruction System, a spinal interlaminal fixation orthosis. It describes the device, its indications for use, and a statement of substantial equivalence to a previously cleared predicate device.
However, this document does not contain information regarding specific acceptance criteria, comprehensive study data, sample sizes, expert qualifications, or ground truth methodologies that would be used to prove the device meets performance criteria in the way a diagnostic or AI-driven device would typically present.
The 510(k) process for a device like the VERTEX™ Reconstruction System (an implantable hardware device) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves:
- Materials testing: Ensuring the materials meet biocompatibility and mechanical strength standards.
- Mechanical testing: Demonstrating that the system components (rods, hooks, screws, connectors) can withstand the expected physiological loads and conditions without failure.
- Design comparison: Showing that the design features and intended use are similar to the predicate.
Given this context, I cannot fill out the requested table and answer many of your specific questions because the information is not present in the provided 510(k) summary. These details are more commonly found for AI/diagnostic software submissions.
Here's what I can provide based on the given text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: (Implied, but not explicitly stated with metrics in this document) | Documentation has been provided which demonstrates the subject VERTEX™ Reconstruction System components are substantially equivalent to VERTEX™ Reconstruction System components previously cleared in K003780 (SE 9/28/01). This implies that the device successfully met the same (or substantially similar) design, material, and mechanical performance requirements as the predicate device. Specific performance metrics (e.g., fatigue strength, pull-out force) are not detailed here. |
| Biocompatibility: (Implied, but not explicitly stated with metrics in this document) | Fabricated from medical grade titanium or titanium alloy. Use of Shape Memory Alloy (Nitinol - NiTi) retaining ring - stated as compatible with titanium or titanium alloy implants only. This implies biocompatibility was addressed through material selection and testing comparable to the predicate. |
2. Sample size used for the test set and the data provenance: Not applicable/Not provided. This document focuses on substantial equivalence based on design and pre-clinical testing, not clinical studies with "test sets" of data as typically defined for AI/diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth in this context would likely refer to engineering standards and material specifications, verified by engineers and materials scientists during device development and testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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 hardware implant, not an AI or diagnostic device that involves "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a hardware device like this, the "ground truth" would generally be established by:
* Engineering standards: Adherence to recognized ASTM, ISO, or other industry standards for medical implants.
* Biocompatibility standards: Confirmation that materials meet established safety profiles for implantation.
* Performance specifications: Mechanical testing results that meet predetermined thresholds for strength, durability, and fatigue.
* Predicate device's established performance: The primary "ground truth" for this 510(k) is that the new components perform as well as or similarly to the predicate device (K003780).
8. The sample size for the training set: Not applicable/Not provided. This is a hardware device; "training sets" are not typically used in its development or evaluation in the same way as for AI.
9. How the ground truth for the training set was established: Not applicable/Not provided.
§ 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.