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The VERTEX™ Reconstruction System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fraumatic dislocations: instability or deformity: failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VERTEX™ Reconstruction System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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. 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. Conditions of the cervical spine, such as degenerative disease, tumor, or trauma, can lead to instability and pain for patients. In order to treat the instability, surgeons may need to use implants to reconstruct the spine. The VERTEX™ Reconstruction System is a comprehensive set of options that provides adjustability, flexibility, and adaptability to meet the anatomical challenges of the occipitocervical and upper thoracic spine. The VERTEX™ Reconstruction System is intended to be implanted by an orthopedic surgeon as described in the Surgical Technique. Each construct is specifically designed for each individual case. The components of the VERTEX™ Reconstruction System are fabricated from medical grades of commercially pure titanium alloy, and cobalt chromium. The VERTEX™ Reconstruction System also includes a retaining ring for the use with the multi-axial screw which is fabricated from Shape Memory Alloy, Nitinol-NiTi.

The provided text is a 510(k) premarket notification for the Medtronic VERTEX™ Reconstruction System. This document outlines the regulatory review process and the basis for the FDA's determination of substantial equivalence to predicate devices. It does not present acceptance criteria or detailed study results for device performance in the way a clinical trial or performance study report would for an AI/ML medical device.

The VERTEX™ Reconstruction System is an orthopedic spinal fixation system, not a software or AI-driven diagnostic device. Therefore, the information typically found in an acceptance criteria table for an AI/ML device (e.g., sensitivity, specificity, AUC) and a detailed description of clinical performance studies (MRMC, standalone, ground truth establishment) is not present in this type of FDA submission.

Instead, the submission focuses on:

• Substantial Equivalence: Demonstrating that the device is as safe and effective as legally marketed predicate devices.
• Technological Characteristics: Highlighting similarities and differences from predicates (in this case, primarily the sterile presentation of the subject rods versus non-sterile for predicates).
• Performance Data (Non-Clinical): Covering biocompatibility (by material equivalence to predicates) and mechanical testing (by relying on predicate device testing as the subject device does not introduce a new worst-case). Endotoxin testing is also mentioned for the sterile product.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets the acceptance criteria, as this information (as it pertains to clinical performance metrics for an AI/ML device) is not contained within the provided document.

The document states:

• VIII. Conclusions: "Based on the sterilization assessment, packaging assessment, and additional supporting documentation provided in this pre-market notification, the subject VERTEX™ Reconstruction System implants demonstrate substantial equivalence to the previously listed predicate devices."

This indicates that the "acceptance criteria" for this device's approval are related to demonstrating mechanical, material, and labeling equivalence, and the "study" is the collection of engineering assessments and comparisons to predicate devices, rather than a clinical performance study with human subjects or a test set of data.

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The VERTEX® Reconstruction System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the instability. The VERTEX® Reconstruction System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

The subject VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, screws, hooks, 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.

This document describes the regulatory clearance for the VERTEX® Reconstruction System, a medical device used for spinal immobilization and stabilization. It does not contain information about studies involving AI or machine learning algorithms. Therefore, much of the requested information regarding AI study specifics cannot be extracted from this document.

However, I can provide available information related to the device's acceptance criteria and the non-clinical and retrospective clinical studies used to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria (or demonstrated equivalence) and Reported Device Performance

The document states that the VERTEX® Reconstruction System is substantially equivalent to the predicate AXIS® Fixation System. This means the acceptance criteria are not explicit performance metrics in a classical sense, but rather a demonstration that the new device performs at least as well as, and has similar technological characteristics to, the legally marketed predicate.

Regarding the device's "performance": The document does not provide specific numerical performance metrics (e.g., success rates, complication rates) for the VERTEX® Reconstruction System or the predicate device. Instead, it relies on the concept of substantial equivalence, implying that its performance is comparable to that of the pre-existing, legally marketed device.

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

• Test Set (for clinical data): The document refers to "Retrospective clinical data provided in support of this application along with the published clinical outcomes of additional patients treated with the VERTEX® device for the indications sought." The sample size for the retrospective clinical data is not specified in this document.
• Data Provenance: The available clinical data is retrospective. The country of origin is not specified but is implicitly from the locations where the VERTEX® device has been used or studied.

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

This information is not available in the provided document. As this is a medical device clearance based on substantial equivalence, the "ground truth" for clinical outcomes would typically be based on established medical evaluations, but the specific process and expert involvement are not detailed.

4. Adjudication method for the test set

This information is not available in the provided document.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as this device does not involve AI or human readers for diagnostic interpretation in the context of the provided regulatory submission.

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

No, a standalone algorithm study was not done as this device is a physical implantable medical device, not an algorithm.

7. The type of ground truth used

For the retrospective clinical data, the "ground truth" would implicitly be the clinical outcomes observed in patients treated with the VERTEX® device, evaluated against the accepted medical standards for spinal fusion and stabilization. However, the specific methodology for establishing this ground truth (e.g., pathology, independent outcomes assessment) is not detailed in the document.

8. The sample size for the training set

This information is not applicable/available as this device is a physical implant and does not involve AI or machine learning models that require training sets.

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

This information is not applicable/available as this device is a physical implant and does not involve AI or machine learning models that require training sets and ground truth.

Ask a specific question about this device

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.

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 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.

Here's an analysis of the provided text regarding the VERTEX® Reconstruction System's acceptance criteria and study information:

Acceptance Criteria and Device Performance

This 510(k) submission for the VERTEX® Reconstruction System is for the addition of new components to an already cleared device. Therefore, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to the existing predicate devices rather than establishing novel performance metrics against a clinical standard.

Table of Acceptance Criteria and Reported Device Performance:

Summary of the Study:

The study conducted was a non-clinical design verification and validation activity specifically aimed at demonstrating substantial equivalence of the new components (lengths and an angled open connection option) to the previously cleared predicate devices.

Specific Information Requested:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not explicitly stated in the provided text. The text mentions "non-clinical testing" was performed on "the subject connectors." For mechanical tests like those mentioned (compression fatigue, static compression, static torsion), specific sample sizes would typically be defined per test in the ASTM standard (ASTM F1717-12). However, the exact number of components tested is not provided.
   • Data Provenance: Not applicable in the context of this 510(k). This was a non-clinical, bench-top mechanical testing study, not a clinical trial involving human patient data. Therefore, there's no country of origin or retrospective/prospective distinction for data collection in the sense of patient data.

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

   • Not applicable. This was a non-clinical, mechanical testing submission. "Ground truth" in this context refers to the defined mechanical properties and performance standards (e.g., tensile strength, fatigue life) which are established by engineering specifications and industry standards (like ASTM F1717-12), not by expert medical opinion on a dataset.

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

   • None. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of imaging or clinical outcomes by multiple experts. This 510(k) describes mechanical bench testing, where performance is measured objectively against predefined engineering specifications.

4. 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:

   • No. This device is a surgical implant (spinal reconstruction system), not an AI-powered diagnostic or imaging interpretation tool. Therefore, an MRMC study comparing human reader performance with or without AI assistance is entirely irrelevant and was not conducted.

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

   • No. This device is not an algorithm. It is a physical medical implant. Therefore, standalone algorithm performance is not applicable.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • The "ground truth" for this submission's non-clinical testing was based on engineering specifications and compliance with recognized industry standards (ASTM F1717-12). The goal was to show that the new components met the same mechanical performance requirements as the predicate devices.

7. The sample size for the training set:

   • Not applicable. This submission describes mechanical testing for a physical implant, not a machine learning model. There is no concept of a "training set" in this context.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for a machine learning model, this question is not relevant.

Ask a specific question about this device

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.

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.

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.

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.

Ask a specific question about this device

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.

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.

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 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 purpose of this submission is to add an adjustable Occipitocervical plate to the system. 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, 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 orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

The provided text is a 510(k) summary for the VERTEX® Reconstruction System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) summary for a spinal fixation orthosis like the VERTEX® Reconstruction System does not typically include clinical study data with acceptance criteria for device performance based on human reader studies, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies in the way one might expect for a diagnostic AI device.

Instead, for devices like these, "acceptance criteria" and "device performance" are primarily demonstrated through mechanical testing to prove that the new device component (the adjustable Occipitocervical plate) is mechanically equivalent to the predicate device and meets established safety standards for implantable medical devices.

Therefore, many of the requested categories for AI/diagnostic studies are not applicable to this document. I will fill in the relevant information as much as possible based on the provided text.

Acceptance Criteria and Device Performance Study for VERTEX® Reconstruction System (K091365)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of clinical data for AI/diagnostic performance. For mechanical testing, specific sample sizes (number of constructs or components tested) would have been used, but these exact numbers are not detailed in the 510(k) summary. These would be found in the full 510(k) submission, not the summary.
• Data Provenance: Not applicable for clinical study data. Mechanical testing data would be generated internally by the manufacturer.

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

• Not Applicable. This is a medical device, not a diagnostic AI system requiring expert consensus on image interpretation or disease diagnosis for a test set. Ground truth for mechanical testing is based on engineering standards and measurements.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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 spinal implant system, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• For mechanical testing: The ground truth is based on established engineering standards, biomechanical principles, and predicate device performance data. The performance of the new component is compared against these benchmarks and the predicate device to demonstrate equivalence. This would include measurements of parameters like yield strength, ultimate tensile strength, fatigue strength, and stiffness.

8. The sample size for the training set

• Not Applicable. This device is not an AI model that requires a training set of data.

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

• Not Applicable. See point 8.

Summary of Relevant Information from the K091365 Document:

The K091365 document is a 510(k) summary for a Class II spinal implant. The primary method for demonstrating "acceptance criteria" and "device performance" relies on proving substantial equivalence to existing predicate devices.

The key statement regarding performance is:
"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 "study" demonstrating performance was mechanical testing of the device components (specifically, the added adjustable Occipitocervical plate). The "acceptance criterion" was that these mechanical test results had to be equivalent to those of previously cleared predicate devices or established standards for such implants. The document does not provide details on the specific test parameters, sample sizes, or numerical results of these mechanical tests within this summary, as is typical for 510(k) summaries. These details would be part of the full 510(k) submission to the FDA.

Ask a specific question about this device

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

The presented document is a 510(k) summary for the VERTEX® Reconstruction System, a spinal fixation device. This type of document is a premarket notification for a medical device submitted to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The 510(k) summary focuses on demonstrating "substantial equivalence" rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be seen for AI/ML-driven devices.

Therefore, many of the requested criteria for AI/ML device studies are not applicable to this document. The study described is primarily a mechanical testing comparison to predicate devices.

Here's an breakdown of the information that can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable: This document describes mechanical testing for substantial equivalence, not a clinical study or an AI/ML model's test set on human data. The "sample size" would refer to the number of components tested mechanically, which is not specified in this summary.
• Data provenance: Not specified, as it's mechanical test data, not patient 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 for AI/ML models or clinical diagnostic studies is not relevant here. The "ground truth" for mechanical testing would be established by engineering standards and validated testing protocols, not expert consensus on medical images or patient outcomes.

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

• Not applicable: Adjudication methods are used in clinical studies or AI/ML model evaluations where there might be disagreement in expert interpretation. This is not how mechanical testing is assessed.

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 surgical implant system, not an AI-assisted diagnostic tool or a system that involves "human readers." No MRMC study was conducted.

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

• Not applicable: This device is a physical surgical implant. There is no algorithm or standalone performance in the context of AI/ML.

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

• For mechanical testing: The "ground truth" is defined by established engineering and biomechanical standards for spinal implant performance, typically involving load-to-failure, fatigue testing, and other mechanical property assessments. It's not a clinical "ground truth" like pathology or outcomes.
• For substantial equivalence: The "ground truth" is the performance and characteristics of the predicate devices.

8. The sample size for the training set

• Not applicable: This involves mechanical testing for substantial equivalence, not an AI/ML model with a training set.

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

• Not applicable: See above. There is no "training set" in the context of this 510(k) submission.

Ask a specific question about this device

When intended as an adjunct to fusion in skelctally mature patients using allograft and/or autograft of the occipitocervical spine, cervical spine, and the thoracic spine, (Occipat-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.

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 spinc.

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods

I he 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.

Reconstruction System is fabricated from medical grade titanium. The VERTEX 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. 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.

The provided document is a 510(k) summary for the VERTEX® Reconstruction System, which is a spinal interlaminal fixation orthosis. This type of regulatory submission in the US is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical effectiveness through full-scale clinical trials with acceptance criteria and detailed device performance metrics typically found in a PMA (Premarket Approval) submission.

Therefore, much of the requested information (acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth characteristics) is not typically included or required in a 510(k) submission like the one provided.

Instead, the acceptance criteria for a 510(k) submission, particularly for devices like spinal fixation systems, are generally related to mechanical testing results demonstrating equivalence to a predicate device, and ensuring that the device's design, materials, and intended use are similar enough that it poses no new questions of safety or effectiveness.

Here's an attempt to address your questions based on the provided text, acknowledging the limitations of a 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided: This information is not typically part of a 510(k) summary for a mechanical spinal implant, which relies on mechanical bench testing rather than clinical study data with test sets of patients. The "test set" here refers to the actual components tested in a lab. The document states "mechanical testing," but does not specify the number of components tested.
• Data Provenance: The mechanical testing would have been conducted in a laboratory environment, likely by the manufacturer (Medtronic Sofamor Danek). The document does not specify the country of origin for the testing itself, but the manufacturer is based in Memphis, Tennessee, USA. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.

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

• Not Applicable / Not Provided: For mechanical bench testing of an implantable device, "ground truth" is established by engineering specifications and recognized testing standards (e.g., ASTM standards for spinal implants), not typically by clinical experts in the same way it would be for diagnostic AI. The document does not mention clinical experts establishing ground truth for the mechanical testing results.

4. Adjudication method for the test set

• Not Applicable / Not Provided: Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of clinical data, especially in diagnostic studies. This is not relevant to mechanical bench testing.

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

• No: No MRMC comparative effectiveness study was done or is mentioned. This device is a surgical implant, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

• No: This device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. The type of ground truth used

• Mechanical Testing Standards and Predicate Performance Data: The ground truth for demonstrating substantial equivalence for this device would be established by validated mechanical testing protocols (e.g., fatigue, static strength) and the known, acceptable performance characteristics of the predicate devices according to these standards. The acceptance criteria would be that the subject device performs equivalently to or better than the predicate device under these standardized tests.

8. The sample size for the training set

• Not Applicable / Not Provided: This is not an AI/algorithm-based device, so there is no "training set." The sample size would refer to the number of components subjected to mechanical testing, which is not specified.

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

• Not Applicable / Not Provided: As there is no training set for an algorithm, this question is not relevant. For the mechanical testing, the "ground truth" for evaluating performance would be established by the engineering specifications of the device and comparing its performance to that of the predicate device under standard mechanical test conditions.

Summary of Approach for 510(k) Devices like VERTEX® Reconstruction System:

The VERTEX® Reconstruction System's 510(k) submission primarily relies on demonstrating Substantial Equivalence to legally marketed predicate devices. This is achieved through:

• Comparison of Indications for Use: Showing that the new device has the same or similar intended use as predicate devices.
• Comparison of Technological Characteristics: Demonstrating that the new device has similar design, materials, and principles of operation.
• Mechanical Testing: Providing data from laboratory-based mechanical testing (e.g., static and fatigue testing) to prove that the device performs equivalently to predicate devices in terms of strength, durability, and other relevant physical properties. The "acceptance criteria" here are that the mechanical test results for the new device fall within the expected, safe, and effective range demonstrated by the predicate devices.

The document explicitly states: "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 statement is the core evidence provided to meet the acceptance criteria for mechanical performance in a 510(k) for this type of device.

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