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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: Plute Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical 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 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.

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® 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 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 allov, 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 orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

This document describes a medical device, the VERTEX® Reconstruction System, and its regulatory clearance. It does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.

The provided text is a 510(k) summary for a medical device (spinal fixation system), which outlines its description, indications for use, and substantial equivalence to previously cleared devices. It details the physical components of the system and their intended use in spinal fusion.

Here's how the requested information maps to the provided text, and why most of it is absent:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory clearance based on substantial equivalence, not on specific performance metrics or acceptance criteria typically associated with clinical trials or AI/ML model validation.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This device is a hardware implant, not an AI/ML software. The "testing" mentioned refers to mechanical testing of the physical components for substantial equivalence, not a clinical test set of data.

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): Not applicable. "Ground truth" in the context of an AI/ML test set is not relevant to this hardware device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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, as this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's regulatory clearance is simply that its mechanical properties and materials are substantially equivalent to predicate devices, and its indications for use are similar.

8. The sample size for the training set: Not applicable, as this is not an AI device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

Key takeaways from the document, relevant to regulatory clearance (but not AI performance criteria):

• Device Type: Spinal fixation system (hardware).
• Purpose: Adjunct to fusion of the occipitocervical and thoracic spine (Occiput-T3).
• Key Clearance Mechanism: Substantial Equivalence to predicate devices (listed as K042789, K070742, K071942, K080805, K082728, K090714, and portions of CD HORIZON® Spinal System K043488).
• "Study" Mentioned: "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components." This refers to laboratory mechanical tests, not clinical studies with patients or data sets.

In summary, this document does not contain the information you requested about acceptance criteria and a study proving device performance as typically understood for AI/ML medical devices. It is a 510(k) summary for a physical implantable device, cleared based on substantial equivalence demonstrated through mechanical testing.

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