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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: 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.

Device Description

The VERTEX® Reconstruction System is a posterior svstem, 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 neurosuraical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

AI/ML Overview

The provided document describes a 510(k) summary for the VERTEX® Reconstruction System, which is a spinal interlaminal fixation orthosis. The purpose of this 510(k) is to add additional components to the existing system. The document does not describe a study involving device performance metrics such as sensitivity, specificity, accuracy, or any form of clinical trial with human subjects where these metrics would be relevant.

Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing (mechanical testing) and by showing that the new components are identical in terms of material, indications for use, and intended use, and that performance specifications are met. Therefore, many of the requested elements about clinical study design (sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new components are based on demonstrating mechanical equivalence to existing predicate devices under specific ASTM standards.

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance/Conclusion
Mechanical Performance	Compression Fatigue (ASTM 1717-12)	Performed on subject tapered rods. The submission concludes that the subject devices demonstrated substantial equivalence to the previously listed predicate devices based on the results of the risk analysis and supporting documentation.
	Static Compression (ASTM 1717-12)	Performed on subject tapered rods. Results contribute to the conclusion of substantial equivalence.
	Static Torsion (ASTM 1717-12)	Performed on subject tapered rods. Results contribute to the conclusion of substantial equivalence.
Design Differences	New components (lengths, diameters, overall design profile) do not present a worst-case scenario compared to predicates with respect to mechanical performance.	Mechanical testing was not required for pre-cut/pre-bent rods, threaded rods, dominoes, crosslinks, or plates, because the differences were limited to additional lengths and diameters, which were determined not to present a worst-case scenario. This implies these design variations met the inherent safety/performance of the predicates.
Material Equivalence	Identical medical grade materials as predicate devices.	The document states, "The subject and predicate parts are identical in terms of material..." The system is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium.
Indications for Use	Identical indications for use as predicate devices.	The document states, "...indications for use... are substantially equivalent to predicate VERTEX® Reconstruction System devices..." and "The subject and predicate parts are identical in terms of material, indications for use, intended use..."
Intended Use	Identical intended use as predicate devices.	The document states, "The subject and predicate parts are identical in terms of material, indications for use, intended use..."
Labeling	Identical labeling as cleared predicate.	The labeling is identical to that cleared in K121191 (S.E. 06/29/12).

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify the exact number of test samples (e.g., number of tapered rods) used for the mechanical tests. However, ASTM standards typically outline the minimum number of samples required for such testing.
Data Provenance: The tests were performed by Medtronic, likely in a laboratory setting, in accordance with ASTM (American Society for Testing and Materials) standards. This is a non-clinical, in-vitro study. Country of origin for data is not explicitly stated but Medtronic Sofamor Danek is based in Memphis, TN, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This submission is based on mechanical performance testing against established engineering standards (ASTM 1717-12) and comparison to predicate devices, not on clinical outcomes or expert interpretation of patient data. Therefore, no "experts" in the sense of clinical reviewers or diagnosticians were used to establish ground truth for a test set.

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

Not Applicable. As this is non-clinical mechanical testing, there is no need for adjudication as typically understood in clinical or imaging studies. Mechanical test results are objective measurements.

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 not a study of AI or a diagnostic device involving human readers or cases. It is a 510(k) for a spinal implant system based on substantial equivalence through mechanical testing and comparison to predicate devices.

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. It's a medical implant system.

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

For the mechanical testing, the "ground truth" is defined by the performance specifications and criteria outlined in the ASTM 1717-12 standard for spinal implant assemblies. The device's performance is compared against these engineering benchmarks. For demonstrating substantial equivalence for other components, the "ground truth" is the established safety and performance of the predicate devices.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI models.

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

Not Applicable. As there is no training set, there is no ground truth established for it.

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K Number

K123568

Device Name

VERTEX RECONSTRUCTION SYSTEM

Manufacturer

MEDTRONIC SOFAMOR DANEK USA, INC.

Date Cleared

2012-12-18

(28 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K121191,K082728,K023555

Intended Use

Occipitocervical Components: Plate Rod / Plates / Rods / Occipital Screws / Hooks

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

Device Description

The VERTEX SELECT® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multiaxial 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 neurosurqical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

The purpose of this Special 510(k) is to add additional components to the VERTEX® Reconstruction System: namely a fixed length and lower profile CROSSLINK® Connector to allow the surqeon additional construct rigidity options when using the VERTEX® Reconstruction System rods and connector components.

AI/ML Overview

This document is a 510(k) premarket notification for the VERTEX® Reconstruction System, specifically for the addition of new components (fixed length and lower profile CROSSLINK® Connector). As such, it's a submission to demonstrate substantial equivalence to a legally marketed predicate device, not typically a study proving performance against acceptance criteria in the way a novel AI or diagnostic device would.

Therefore, many of the typical "acceptance criteria" and "study" elements you've requested (e.g., sample size, ground truth, MRMC study, standalone performance) are not applicable in this context. This submission focuses on non-clinical testing and an engineering rationale rather than clinical trial data demonstrating performance against specific clinical endpoints.

Here's a breakdown of the available information based on your request, highlighting what is and isn't present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a formal table of "acceptance criteria" for the new components in the way a diagnostic device might have performance metrics. Instead, "acceptance" for a 510(k) submission is based on demonstrating substantial equivalence, which is achieved through an engineering rationale and risk assessment for changes to existing devices.

The "performance" is implicitly deemed equivalent to the predicate devices because the new components do not introduce new issues of safety or effectiveness, share the same materials, indications for use, and intended use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No clinical test set in the traditional sense was used. The submission relies on an engineering rationale and risk assessment for the component modification.
Data Provenance: Not applicable. No patient data (retrospective or prospective) was used for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No ground truth establishment by experts for a test set was performed.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

Not applicable. This is not a study assessing human reader performance with or without AI assistance.

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

Not applicable. This is a medical device (spinal implant components), not an algorithm or AI.

7. The Type of Ground Truth Used

Not applicable. No ground truth in the context of diagnostic accuracy was established. The "ground truth" for this submission is that the modified device, through engineering and risk analysis, is considered substantially equivalent to already cleared devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary of the Study/Rationale Presented in the Document:

Instead of a typical performance study with acceptance criteria, this 510(k) submission (K123568) for the VERTEX® Reconstruction System's new CROSSLINK® Connector relied on:

Engineering Rationale: Demonstrating that the modifications (fixed length and lower profile CROSSLINK® Connector) maintain the same material, indications for use, intended use, and performance specifications as the predicate devices.
Risk Assessment: Proving that the new CROSSLINK® does not introduce new issues of safety or effectiveness.
Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

Predicate Devices:
The predicate devices identified are:

VERTEX® Reconstruction System (K082728 - SE 01/16/2009)
VERTEX® Reconstruction System (K023555 - SE 11/22/2002)

Conclusion:
The FDA reviewed the provided engineering rationale and risk assessment and determined that the VERTEX® Reconstruction System (with the added components) is substantially equivalent to its predicate devices, hence accepting the submission and allowing continued marketing.

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