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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.

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 VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium allov, 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 multi-axial screws contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog or price list for further information about warranties and limitations of liability.

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, which is a spinal interlaminal fixation orthosis. It primarily discusses the device's description, indications for use, and a statement of substantial equivalence to predicate devices. It does NOT contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics commonly used for AI/software devices (e.g., sensitivity, specificity, AUC).

Instead, the "study" mentioned refers to mechanical testing performed to demonstrate substantial equivalence to previously marketed devices.

Therefore, I cannot provide the requested information in the format of acceptance criteria and device performance as this document does not contain that type of data.

However, I can extract the relevant information from the document to address the components of your request as best as possible given the available text:

Summary of Information from the Provided Document:

This 510(k) summary is for a medical device (spinal implant system), not an AI/software device. The concept of "acceptance criteria" and "device performance" in the context of AI models (like sensitivity, specificity, AUC, sample size of test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable or detailed in this type of regulatory submission for a physical implant.

The "study" referenced in the document is mechanical testing to demonstrate substantial equivalence.

Here's a breakdown based on the provided text, addressing your points where possible, and noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Implicit): The primary acceptance criterion for this 510(k) submission is "Substantial Equivalence" to legally marketed predicate devices. This is demonstrated by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states: "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to or better than the testing performed for the predicate VERTEX® Reconstruction System components."
  • Specific performance metrics (e.g., strength, durability, fatigue resistance) are not enumerated in this summary document, nor are numerical acceptance thresholds. The summary only provides the conclusion of the mechanical testing.

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

• Not applicable in the context of AI/software test sets. The "test set" here would refer to the samples used in mechanical testing.
• Sample Size: Not specified in the document.
• Data Provenance: Not specified in the document (country of origin, retrospective/prospective). This would apply to the origin of the mechanical test samples themselves or the testing methodology.

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

• Not applicable in the context of AI/software ground truth. The "ground truth" for a physical implant's mechanical testing comes from engineering standards and physical measurements.
• Number of Experts & Qualifications: Not specified, as it's not relevant to mechanical testing for substantial equivalence in this context.

4. Adjudication Method for the Test Set

• Not applicable in the context of AI/software adjudication. Mechanical testing results are typically objectively measured and compared to predefined engineering specifications or predicate device performance, not adjudicated by human experts in the way AI model outputs are.

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

• No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for the regulatory approval of a physical spinal implant system.

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

• Not applicable. This device is a physical spinal implant system, not an algorithm.

7. The Type of Ground Truth Used

• Engineering/Mechanical Standards and Predicate Device Performance: The "ground truth" for the mechanical testing would be established by industry standards for spinal implants and/or the measured performance of predicate devices against which the new system is being compared for substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical spinal implant system, not an AI model requiring a training set.

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

• Not applicable. There is no "training set" for this type of device.

In conclusion: The provided document is a 510(k) summary for a physical medical device (spinal implant). It is focused on demonstrating "substantial equivalence" through mechanical testing, not on the performance metrics or study designs typically associated with AI or software devices as implied by your detailed questions.

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.

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 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 multi-axial screws contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog or price list for further information about warranties and limitations of liability.
To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

This document is a 510(k) premarket notification for the VERTEX® Reconstruction System, a spinal fixation device. It is not a study that proves a device meets acceptance criteria, but rather a submission to demonstrate substantial equivalence to previously marketed devices. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a typical AI/software device cannot be extracted directly from this document.

However, I can provide what can be inferred from the document regarding the "study" that proves substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The "test set" in this context refers to the components of the VERTEX® Reconstruction System that underwent mechanical testing.
• Data Provenance: Not specified. This would typically be internal testing data (bench testing).

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

• Not applicable. The "ground truth" for a mechanical device is established through engineering specifications and objective mechanical testing. Human experts are not used to establish this type of ground truth.

4. Adjudication Method for the Test Set

• Not applicable. Mechanical testing results are typically objectively measured and compared to predefined criteria, not subject to adjudication in the human consensus sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is involved. This document describes a surgical implant device.

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

• Mechanical Test Results: The "ground truth" for demonstrating substantial equivalence relied on objective measurements from mechanical testing (e.g., strength, fatigue, static/dynamic loading) and comparison to the performance of predicate devices.
• Material Science Principles: Ground truth for material compatibility and safety is based on established medical device material science and biocompatibility standards.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an algorithm that requires a "training set" for machine learning.

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

• Not applicable, as there is no "training set" or algorithm involved.

Summary of the "Study" Proving Substantial Equivalence:

The "study" referenced in this 510(k) submission is primarily a mechanical testing study (bench testing) that compared the performance characteristics of the new VERTEX® Reconstruction System components to those of previously cleared predicate devices (K052402, K052734). The acceptance criterion was that the new device's mechanical performance should be "equivalent to or better than" the predicate devices. The document explicitly states that this criterion was met. This type of submission demonstrates that the new device is as safe and effective as existing legally marketed devices, rather than presenting a novel clinical trial.

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.

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 construct 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, titanium alloy, and or/cobalt chromium with ataless 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) - Thane Memory Alloy is compatible with titanium, titanium alloy, and cobalt chrom. Shippe only. Some multi-axial screws contain elastomeric stakes made of silicore adhesive commonly used in implantable medical devices. Do not use with stainless steel. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog or price list for further information about warranties and limitations of liability.
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 orthopedia 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. It describes the device, its indications for use, and its substantial equivalence to other legally marketed devices.

However, the document does not contain any information regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The "V. Substantial Equivalence" section mentions: "The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to or better than the testing performed for the predicate VERTEX® Reconstruction System components." This indicates that some form of testing was done to demonstrate equivalence, likely mechanical strength or fatigue testing, but the specific acceptance criteria and detailed results are not provided in this summary.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or the other detailed information about a study based on the provided text. The document is a regulatory summary, not a detailed study report.

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.

Occipitocervical Plate/Rod/Occipital Screws/Hooks: The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), 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. The use of the occipitocervical plate/rod requires 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 (3.5mm and 4.0mm cancellous, and 4.0mm cortical) 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.

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plate/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 ATI.A.S® 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 or titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Never use stainless steel and titanium implant components in the same construct. 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 Sofamor Danek document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances. The purpose of this submission was to add modified components to the system including cannulated screws, set screws and a longer medical grade titanium 5.5mm rod.

The provided text describes a 510(k) submission for the VERTEX® Reconstruction System, a spinal fixation device, and not a software algorithm or AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria and studies for device performance in the context of AI (e.g., sample sizes for test sets, expert ground truth, MRMC studies) is not applicable to this submission.

However, I can extract the relevant information about how the device meets acceptance criteria, which, for a physical medical device, primarily revolves around substantial equivalence to a legally marketed predicate device, supported by mechanical testing where appropriate.

Here's a breakdown of the provided information within the framework of your request, noting where information is not applicable:

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

For this medical device, the primary "acceptance criterion" for regulatory clearance is Substantial Equivalence to a predicate device. The "performance" reported is essentially the demonstration of this equivalence.

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 in the context of an AI/software test set. This is a spinal implant.
• For the mechanical tests mentioned, the specific sample sizes for components tested are not detailed in this summary. The data provenance (e.g., where the tests were performed) is also not specified. These are typically performed in a lab setting by the manufacturer.

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. This is not an AI diagnostic device that relies on expert ground truth for image interpretation or similar. The "ground truth" for a physical device like this is its mechanical properties and biocompatibility, as demonstrated through engineering tests.

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

• Not Applicable. This concept is for clinical studies or AI performance evaluations, not for a 510(k) submission based on substantial equivalence and mechanical testing of an orthopedic implant.

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 an orthopedic implant, not an AI-assisted diagnostic tool.

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

• Not Applicable. No algorithm is being submitted for standalone performance.

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

• For the purpose of demonstrating substantial equivalence, the "ground truth" implicitly relies on:
  • Mechanical properties benchmarks: The performance of the predicate device (K042789) and established industry standards for spinal implant mechanics.
  • Material properties: Conformance to medical-grade titanium and titanium alloy specifications, and the Nitinol properties for the retaining ring.

8. The sample size for the training set

• Not Applicable. No AI model is being trained.

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

• Not Applicable. No AI model is being trained.

Ask a specific question about this device

When intended to promote fusion of the occipitoccrvical 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.

Occipitocervical Plate/Rod/Occipital Screws/Hooks: The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous along with 4.0mm and 4.5mm cortical), 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. The use of the occipitocervical plate/rod requires 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 (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

The titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine,

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailormade for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion.

The VERTEX® Reconstruction System is fabricated from medical grade titanium or titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Never use stainless steel and titanium implant components in the same construct.

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 allowed to do so in this or another Medtronic Sofamor Danek document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

The purpose of this submission was to add the KEEL Plate to the system , to expand the use of the VERTEX® M6 Set Screws to include the occiput and to correct a clerical error related to the 4.0mm and 4.5mm cortical screws.

This document is a 510(k) summary for the VERTEX® Reconstruction System, a spinal fixation device. It details product description, indications for use, and a statement of substantial equivalence to previously cleared devices. This document does not contain information about acceptance criteria or a study demonstrating device performance against such criteria in the context of an AI/ML device.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document is primarily concerned with establishing substantial equivalence for a medical device (spinal implant components) to predicate devices, which is a regulatory pathway for hardware-based medical devices, not typically for AI/ML software. The "study" mentioned, a "risk analysis," was to demonstrate substantial equivalence, not to prove performance against specific acceptance criteria in the way you've outlined for an AI/ML product.

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.

Occipitocervical Plate/Rod/Occipital Screws/Hooks: The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spinc. 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. The use of the occipitocervical plate/rod requires 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 (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailormade for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. The VERTEX® Reconstruction System is fabricated from medical grade titanium or titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with medical grade titanium or titanium alloy implants only. Do not use with stainless steel. The purpose of this submission was to add modified lateral connectors to the VERTEX® Reconstruction System.

This is a 510(k) premarket notification for a medical device (VERTEX® Reconstruction System), which focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness through a traditional clinical study with acceptance criteria and measured device performance.

Therefore, the provided document does not contain the information requested regarding acceptance criteria or a study proving the device meets them in the way a clinical trial or performance study would for a new device.

Here's why and what information is available:

• Type of Submission: This is a 510(k) submission. For 510(k)s, the primary goal is to show the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if there are different technological characteristics, they do not raise different questions of safety and effectiveness.
• Missing Information: The document does not describe:
  • Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for device performance.
  • A study designed to measure the device's performance against such criteria.
  • Sample sizes, data provenance, expert ground truth establishment, adjudication methods for a test set, MRMC studies, or standalone algorithm performance.
  • Training set details for an algorithm, as this device is a mechanical implant, not an AI/software device.
• What is Present: The document states that "Documentation has been provided which demonstrates that the VERTEX® Reconstruction System is substantially equivalent to VERTEX® Reconstruction System that was previously cleared in K042524 and K003780." This is the "study" and "proof" in the context of a 510(k) – it's a comparison to predicates, not a performance evaluation against a set of criteria.

In summary, as this is a 510(k) for a mechanical spinal implant system, the requested information pertaining to acceptance criteria and a study demonstrating performance in the context of AI/software algorithm evaluation (like sensitivity, specificity, expert ground truth, sample sizes, etc.) is not applicable and is not present in the provided text. The "study" here is a substantial equivalence comparison to predicate devices, which is a regulatory pathway, not a performance measurement study in the typical sense.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and the thoracic spine, (CI-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.

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.

The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailormade for the individual case. Titanium ATLAS™ cable may be used with this system at the surgeon's discretion.

The VERTEX® Reconstruction System is fabricated from medical grade titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel.

The purpose of this submission was to add modified setscrews to the existing system.

The provided text is a 510(k) summary for the VERTEX® Reconstruction System, a spinal fixation device. It details the device's description, indications for use, and a claim of substantial equivalence to previously cleared devices.

Crucially, this document does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures. The approval is based on "substantial equivalence" to existing cleared devices, primarily supported by mechanical test results.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide answers to the questions regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These types of details are not typically found in a 510(k) summary for a spinal implant device, as the regulatory pathway relies on demonstrating equivalence rather than establishing new performance benchmarks through clinical or AI-specific studies.

The document states:

• Substantial Equivalence: "Documentation, including mechanical test results, has been provided which demonstrates that the subject VERTEX™ Reconstruction System components are substantially equivalent to VERTEX® Reconstruction System components previously cleared in K042498 (SE 10/07/04) and K042789 (SE 12/21/04)."

This indicates that the "study" proving the device met the criteria was a demonstration of its mechanical and material properties being comparable to already approved devices, rather than a clinical trial or performance study against specific acceptance criteria for diagnostic or algorithmic performance.

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When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEXTM Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods: The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors: The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable System to be used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

The VERTEX™ Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with cach construct being tailormade for the individual case. Titanium ATLAS™ cable may be used with this system at the surgeon's discretion.

The VERTEX™ Reconstruction System is fabricated from medical grade titanium alloy. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with medical grade titanium alloy implants only. Do not use with stainless steel.

The purpose of this submission was to add modified CROSSLINK® Plates and set screws to the system.

The provided text describes a 510(k) premarket notification for the VERTEX™ Reconstruction System, a spinal interlaminal fixation orthosis. It indicates FDA clearance based on substantial equivalence to previously cleared devices. However, the document does not contain any information about acceptance criteria, detailed device performance studies, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them. This type of detailed performance data is typically found in the full 510(k) submission, which is not fully available in this extract. The provided text is primarily the 510(k) summary and the FDA's clearance letter, which focus on indications for use and substantial equivalence to predicates rather than detailed performance metrics.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEX™ Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors

The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable System to be used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

The VERTEX™ Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailormade for the individual case. Titanium ATLAS™ cable may be used with this system at the surgeon's discretion.

The VERTEX™ Reconstruction System is fabricated from medical grade titanium or titanium alloy. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel.

The purpose of this submission was to modify the existing tulip head design into a smooth post screw, and to update the offset connector and eyebolt connection.

The provided text is a 510(k) summary for the VERTEX™ Reconstruction System. It is a submission to modify an existing medical device, specifically a posterior spinal system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Key reasons for this are:

• 510(k) Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a predicate device (a device already legally marketed). This typically involves comparing device design, materials, indications for use, and technological characteristics, and showing that any differences do not raise new questions of safety or effectiveness. It generally does not require new clinical performance studies with acceptance criteria in the way a PMA (Pre-Market Approval) would.
• Device Type: The VERTEX™ Reconstruction System is a spinal implant system (rods, screws, hooks, connectors). The modifications described are to the tulip head design of a screw and updates to an offset connector and eyebolt connection. These are mechanical components. Performance is typically established through bench testing (e.g., fatigue, load-bearing) and material characterization, which are often cited by reference to established standards or previous submissions, rather than clinical studies with human subjects.
• Lack of Performance Data: The document explicitly states: "Documentation has been provided which demonstrates that the VERTEX™ Reconstruction System is substantially equivalent to VERTEX™ Reconstruction System that was previously cleared in K023555 and K003780." There are no sections detailing a study design, sample sizes, ground truth establishment, or performance metrics against specific acceptance criteria.

Conclusion:

Based on the provided text, I cannot complete the requested tables and information because the document describes a 510(k) submission focused on substantial equivalence rather than a study with defined acceptance criteria and performance data. There is no mention of a clinical study, human readers, AI assistance, or expert consensus protocols for evaluating performance.

Ask a specific question about this device

When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEX™ Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors

The use of screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable System to be used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

The VERTEX™ Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailormade for the individual case. Titanium ATLAS™ cable may be used with this system at the surgeon's discretion.

The VERTEX™ Reconstruction System is fabricated from medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi) as described by ASTM F2063. Shape Memory Alloy is compatible with titanium alloy implants only. Do not use with stainless steel. Medtronic Sofamor Danek expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for further information about warranties and limitations of liability. Never use stainless steel and titanium implant components in the same construct.

The purpose of this submission was to add a CROSSLINK® Clip, a CROSSLINK® Bar and a modified laminar hook to the system.

The provided text is a 510(k) summary for the VERTEX™ Reconstruction System. It describes the device, its indications for use, and states that it was found to be substantially equivalent to itself (meaning it's an update to an already cleared device).

However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to a predicate device, rather than providing performance study results against predefined acceptance criteria for a new AI/software device.

Therefore, I cannot populate the requested table and study details based on the provided text. The questions posed are typically relevant for AI/ML-driven or software-based medical devices where performance metrics (sensitivity, specificity, accuracy, etc.) are crucial for demonstrating safety and effectiveness. The VERTEX™ Reconstruction System is a physical implantable device.

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