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When intended as an adjunct to fusion in skeletally mature patients using allograft and/or autograft 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 prev10us fusion and/or tumors

Occipitocervical Components Plate 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 hist 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 Allov (Nitinol ~ NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. The posted screw connectors and some multi-axial screws 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 is a 510(k) summary for the VERTEX® Reconstruction System, a spinal implant device. It primarily discusses the device's description, indications for use, and substantial equivalence to existing predicate devices.

This document does not contain information on acceptance criteria, device performance, or any study involving human or even simulated data to prove the device meets specific performance criteria. It focuses on regulatory approval based on substantial equivalence to previously approved devices and mechanical testing results.

Therefore, I cannot provide a detailed response to your request, as the necessary information for acceptance criteria and a study proving their fulfillment is not present in the provided text.

Specifically, the document states:

• "VI. Substantial Equivalence Documentation was provided demonstrating that the VERTEX® Reconstruction System is substantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices..."
• "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 indicates that the main "proof" for this submission was demonstrating substantial equivalence through comparison to legally marketed devices and equivalent mechanical testing, rather than a clinical performance study with specific acceptance criteria.

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When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the GALAXY™ 3.2 Spinal System is indicated for the following:

DDD (neck pain of discogenic origin with degencration 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 is limited to placement in T1-T3 in treating thoracic conditions only.

Screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable used with the GALAXY™ 3.2 Spinal System allows for cable attachment to the posterior cervical or thoracic spine.

The GALAXY™ 3.2 Spinal System consists of a variety of shapes and sizes of screws, hooks, rods 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. This system is intended for posterior use only.

Titanium implant components from other previously cleared Medtronic Sofamor Danek Spinal Systems can be used in conjunction with the GALAXY™ 3.2 Spinal System. These systems include the TSRH®, CD HORIZON®, DYNALOK™ PLUS, DYNALOK CLASSIC™ spinal systems and VERTEX™ Reconstruction Systems. Additionally, titanium ATLAS cable may be used with this system at the surgeon's discretion.

The GALAXY™ 3.2 Spinal System is fabricated from medical grade titanium or titanium alloy.

The GALAXY™ 3.2 Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, cervical and/or sacral spine. The GALAXY™ 3.2 Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the GALAXY™ 3.2 Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

The provided text is a 510(k) summary for the GALAXY™ 3.2 Spinal System, which is a medical device for spinal fixation. This document is a regulatory submission for market clearance, not a study report proving a device meets acceptance criteria in the way a clinical trial or performance study would for an AI/software device.

A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device. This means the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The information provided does not describe a clinical study in the typical sense of testing the device's "performance" against specific acceptance criteria with a particular sample size, ground truth, or expert review for diagnostic accuracy.

Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory document.

However, I can provide what information is available based on the request:

1. A table of acceptance criteria and the reported device performance

This document does not specify "acceptance criteria" for performance in the context of a clinical study or a comparative performance metric, nor does it report specific device performance metrics like sensitivity, specificity, or accuracy. The "performance" described is its intended use and mechanical function as a spinal fixation system.

The core "acceptance criteria" for a 510(k) is the demonstration of substantial equivalence to a predicate device.

The intended clinical performance is to stabilize the spine for conditions such as DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and tumors in the cervical (C1-T3) and thoracic spine. Specific uses for hooks, rods, and screws are detailed, with screws specifically limited to T1-T3 for thoracic conditions and not for the cervical spine. Titanium ATLAS™ Cable can be used for cable attachment to the posterior cervical or thoracic spine. |

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 document is not a clinical study report that would involve a "test set" in the context of AI/software performance. It's a regulatory submission affirming substantial equivalence based on device design, materials, and intended use, often supported by mechanical testing data (which is not detailed here) and comparison to existing predicate devices.

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 establishment with experts is relevant for diagnostic devices or AI, not for a spinal implant system's 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication method is described.

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 device is a physical spinal implant, not an AI or diagnostic tool. Therefore, MRMC studies and "human reader improvement with AI" are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No "ground truth" in this sense is established for the device itself. The "truth" in a 510(k) is that the device is substantially equivalent to a predicate, implying comparable safety and effectiveness based on established medical and engineering principles.

8. The sample size for the training set

Not applicable. No training set is involved for this type of device submission.

9. How the ground truth for the training set was established

Not applicable. No training set or ground truth in this context.

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