Search Results

The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic ZPLATE II™ Anterior Fixation System, the DYNA-LOK CLASSIC® Spinal System, the VANTAGE® Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System and/or the GDLH® Spinal System. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

The VERTE-STACK® device consists of hemi-cylindrical center cages of various lengths and diameters, as well as hemi-cylindrical add on cages of various lengths, diameters and angulation. The assembled VERTE-STACK® device consists of three components (one hollow center cage, and two hollow add-on cages). The VERTE-STACK® components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK® Spinal System implant components are made of medical grade PEEK-OPTIMA LT1 along with a marker made from either Tantalum or titanium. Alternatively, VERTE-STACK® Spinal System may be manufactured from titanium alloy.

The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured from PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission was to modify the geometry of the implants and to include additional sizes into the existing VERTE-STACK® Spinal System.

The provided text describes a 510(k) summary for the VERTE-STACK® Spinal System, focusing on its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, device performance studies with sample sizes, expert involvement, adjudication methods, or specific details about standalone or MRMC studies for AI devices.

Instead, the submission states that "Documentation, including mechanical test results, was provided which demonstrated that the subject VERTE-STACK® Spinal System components are substantially equivalent to the previously cleared VERTE-STACK® Spinal System (K052931, SE 11/13/2005; and K062133, SE 09/26/2006)." This implies that the acceptance criteria and assessment of equivalence are based on mechanical properties rather than clinical performance evaluated with the types of studies you've asked about (e.g., those involving AI, ground truth, experts, etc.).

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions related to AI studies, expert-established ground truth, or adjudication methods, as this information is not present in the provided text. The submission is for a physical medical device (vertebral body replacement) and not an AI/software device.

Ask a specific question about this device

The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

The VERTE-STACK® device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK® device is fabricated and manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT1) along with either titanium or tantalum markers. Alternatively the entire device may be manufactured from titanium alloy.

The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

This 510(k) summary describes a modification to an already cleared device, the VERTE-STACK® Spinal System. The provided document therefore focuses on demonstrating substantial equivalence to previously cleared predicates rather than presenting de novo performance studies with acceptance criteria as would be required for a novel device.

The original submission for the VERTE-STACK® was based on mechanical testing to ensure the device's structural integrity and functionality for its intended use, rather than a clinical study measuring AI performance. The provided document does not contain information typically associated with AI/ML device evaluations.

Therefore, many of the requested fields cannot be filled.

Acceptance Criteria and Study for VERTE-STACK® Spinal System

Based on the provided 510(k) summary for the VERTE-STACK® Spinal System, the device described is a medical implant (a vertebral body replacement device) and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as it relates to AI/ML performance (e.g., accuracy, sensitivity, specificity, effect size with human readers) is not applicable here.

Instead, for this type of medical device, the acceptance criteria would typically relate to:

• Mechanical performance: demonstrating that the device can withstand the physiological loads and stresses it will encounter in the spine (e.g., compression, torsion, bending, fatigue life).
• Biocompatibility: ensuring the materials used are safe for implantation in the human body.
• Sterilization: verifying that the device can be effectively sterilized without compromising its integrity.
• Design and manufacturing specifications: ensuring the device is manufactured consistently and according to its intended design.
• Substantial equivalence: comparing the device features and indications for use to legally marketed predicate devices.

The "study" that proves the device meets the acceptance criteria would primarily involve non-clinical testing (e.g., mechanical bench testing) and comparative analysis to predicate devices.

Summary of Device Performance and Equivalence Claim:

The purpose of this specific 510(k) (K062133) is to include "slightly modified components" to the previously cleared VERTE-STACK® Spinal System. Therefore, the primary "study" proving its acceptance criteria is a demonstration of substantial equivalence to the previously cleared versions of the VERTE-STACK® Spinal System (K060719 and K041556).

Here's a breakdown of the requested information, adapted for a non-AI/ML medical device submission focused on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion (Implied for Spinal Implants)	Reported Device Performance / Evaluation Method
   Substantial Equivalence to Predicate Devices	"Documentation was provided which demonstrated that the subject VERTE-STACK® Spinal System components are substantially equivalent to components previously cleared in VERTE-STACK® Spinal System 510(k) applications K060719 (SE 04/14/06) and K041556, (SE 07/01/04)."
   Material Biocompatibility (e.g., PEEK OPTIMA LT1, Titanium, Tantalum)	The device is fabricated from well-established biocompatible materials (PEEK OPTIMA LT1 with titanium/tantalum markers or entire titanium alloy). Implicitly accepted due to prior clearance of these materials in spinal implants. No specific testing reported in this summary.
   Mechanical Integrity & Performance (e.g., strength, fatigue)	Not explicitly detailed in this summary, but would have been part of the original predicate device clearances (K060719, K041556). The modifications are "slightly modified components," implying previous mechanical testing results are still applicable or updated as needed.
   Safety and Effectiveness for Indications for Use (Thoracolumbar spine T1-L5)	Demonstrated through substantial equivalence to predicate devices with identical indications for use.

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

   • Not applicable. This submission relies on substantial equivalence to predicate devices, not a test set of data in the context of an AI/ML device. The "test" is the comparison to existing cleared devices.

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

   • Not applicable. No ground truth establishment by experts for a test set is described. The FDA's review process itself involves experts (e.g., regulatory reviewers, engineers, clinicians) who evaluate the submission for substantial equivalence.

4. Adjudication method for the test set:

   • Not applicable. No test set requiring adjudication in the AI/ML context.

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 an AI-assisted device.

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

   • Not applicable. This is not an algorithm/AI device.

7. The type of ground truth used:

   • Not applicable. For this type of device and submission, the "ground truth" for substantial equivalence is the regulatory acceptance and performance history of the predicate devices. The safety and effectiveness of the predicate devices are typically established through a combination of non-clinical testing, design specifications, and clinical experience (or sometimes clinical studies for PMAs or more complex devices).

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

The VERTE-STACK® device consists of hemi-cylindrical center cages of various lengths and diameters, as well as hemi-cylindrical add on cages of various lengths, diameters and angulation. The assembled VERTE-STACK® device consists of three components (one hollow center cage, and two hollow add-on cages). The VERTE-STACK® components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK® Spinal System implant components are made of medical grade PEEK-OPTIMA LT1 along with a marker made from either Tantalum or titanium. Alternatively, VERTE-STACK® Spinal System may be manufactured from titanium alloy.

The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured from PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission was to modify the wording of the VERTE-STACK® Spinal System package insert by removing certain contraindications and by including a NOTA BENE for potential factors to consider with regards to when not to use this device. The rewording of the document makes it more consistent with that of the package insert for the CD HORIZON® Spinal System, which may be used as the supplemental fixation device for the VERTE-STACK® device.

This is a 510(k) summary for a spinal implant device, the VERTE-STACK® Spinal System, rather than a diagnostic AI device. Therefore, the information requested regarding acceptance criteria and studies proving device performance for AI-based systems (e.g., sample size for test set, AI vs. human reader improvement, ground truth establishment) is not applicable in this context.

This summary details a modification to the package insert of an existing device and establishes its substantial equivalence to previously cleared predicate devices. It does not contain information about performance studies in the way an AI/ML device submission would.

Here's an attempt to answer the applicable parts based on the provided text, while noting the limitations:

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

The document does not specify "acceptance criteria" or "reported device performance" in the typical sense of a diagnostic or AI device. Instead, the focus is on substantial equivalence to predicate devices. The "performance" assessment is implied by demonstrating that:

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 is a 510(k) submission for a spinal implant, not an AI or diagnostic device that typically undergoes performance testing with test sets of data. The submission relies on demonstrating substantial equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth establishment with experts is relevant for AI or diagnostic devices, not for a spinal implant demonstrating substantial equivalence.

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

Not applicable. Adjudication methods are relevant for evaluating expert consensus in diagnostic studies, which is not the type of study presented here.

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. MRMC studies are for evaluating diagnostic performance, often in the context of AI assistance. This document describes a surgical implant.

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

Not applicable, as this is not an AI device.

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

Not applicable in the context of a diagnostic or AI device's ground truth. However, in the context of a medical device submission striving for substantial equivalence, the "ground truth" is implicitly established by the safety and effectiveness of the predicate devices and the regulatory standards for such devices.

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.

In summary: The provided document is a 510(k) summary for a physical medical device (spinal implant) and its label modification, not an AI/ML or diagnostic device. Therefore, the questions related to AI acceptance criteria, test sets, ground truth establishment, and multi-reader studies are not addressed by the document. The "study" described is the submission of documentation to demonstrate substantial equivalence to predicate devices.

Ask a specific question about this device

The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, the DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, the GDLH® Spinal System and/or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

The VERTE-STACK® device consists of hemi-cylindrical center cages of various lengths and diameters, as well as hemi-cylindrical add on cages of various lengths, diameters and angulation. The assembled VERTE-STACK® device consists of three components (one hollow center cage, and two hollow add-on cages). The VERTE-STACK® components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK® Spinal System implant components are made of medical grade PEEK-OPTIMA LT1 along with a marker made from either Tantalum or titanium. Alternatively, VERTE-STACK® Spinal System may be manufactured from titanium alloy.

The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured from PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission was to modify the geometry of the implants and to include additional sizes into the existing VERTE-STACK® Spinal System.

The provided document describes a 510(k) premarket notification for the VERTE-STACK® Spinal System, a medical device for vertebral body replacement. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than a study proving the device meets specific acceptance criteria through clinical or performance measures against a defined ground truth.

This submission is for a modification to the geometry and additional sizes of an existing device, relying on mechanical test results to show substantial equivalence to predicate devices (K060719 and K052931). Therefore, the concept of "acceptance criteria" for clinical performance, ground truth, expert adjudication, multi-reader multi-case studies, or standalone algorithm performance, as typically understood in AI/imaging device submissions, is not directly applicable here.

Instead, the "acceptance criteria" are implied by the regulatory standard for 510(k) clearance: demonstration of substantial equivalence to a legally marketed predicate device.

Given the nature of this document, much of the requested information does not apply. Here's a breakdown based on the provided text:

Acceptance Criteria and Study Details for VERTE-STACK® Spinal System (K062073)

The acceptance criteria for this 510(k) submission are not expressed as specific performance metrics (e.g., sensitivity, specificity) but rather as the demonstration of "substantial equivalence" to predicate devices. This is achieved through mechanical testing and comparison of design features.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of data for AI/imaging. The "test set" in this case refers to the modified device components and their mechanical testing. The document does not specify the number of components or test specimens.
• Data Provenance: The study described is mechanical testing performed by the manufacturer, Medtronic Sofamor Danek. No information is provided regarding the country of origin of this data, but it would typically be conducted in controlled laboratory environments. The study is akin to a prospective engineering validation of the new design, rather than retrospective analysis of clinical data.

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

• Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on diagnosis or interpretation, is not established for this type of mechanical device submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no clinical imaging test set requiring adjudication in this submission. The "adjudication" is essentially the FDA's regulatory review of the provided mechanical test data and comparison to predicate devices, performed by agency experts.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This is a submission for a mechanical implant, not an AI or imaging diagnostic device where human reader performance is assessed.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Study: Not applicable. This device is a mechanical implant, not an algorithm. The "standalone" performance refers to the device's mechanical integrity as demonstrated by testing, which is its inherent function without a "human-in-the-loop" interpretative aspect.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is based on engineering standards, material specifications, and benchmark mechanical performance data established for the predicate devices. The mechanical test results for the new device were compared against these established specifications to demonstrate equivalence.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/machine learning submission; therefore, there is no "training set."

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

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device

The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

The VERTE-STACK® device consists of hemi-cylindrical center cages of various lengths and diameters, as well as hemi-cylindrical add on cages of various lengths, diameters and angulation. The assembled VERTE-STACK® device consists of three components (one hollow center cage, and two hollow add-on cages). The VERTE-STACK® components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK® Spinal System implant components are made of medical grade PEEK-OPTIMA LT1 along with a marker made from either Tantalum or titanium. Alternatively, VERTE-STACK® Spinal System may be manufactured from titanium allov.

The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured from PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission was to add slightly modified centerpieces to the existing VERTE-STACK® Spinal System.

This document describes the VERTE-STACK® Spinal System, a medical device designed for vertebral body replacement. The key information for this submission is that it's a 510(k) premarket notification for modifications to an existing device, specifically the addition of "slightly modified centerpieces" to the already cleared VERTE-STACK® Spinal System.

Due to the nature of this submission being an update/modification to an already cleared device through a 510(k) pathway, the "study" proving it meets acceptance criteria is typically a demonstration of substantial equivalence to the predicate device, not necessarily a de novo clinical trial with human subjects.

Here's a breakdown based on your request, as much as can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: This information is not explicitly provided in the document. Mechanical testing typically involves a set number of components tested for various parameters (e.g., compression, torsion, fatigue) according to recognized standards. The document only mentions "mechanical test results."
• Data Provenance: The data provenance is from Medtronic Sofamor Danek's internal testing. It is not specified if any external labs were used. The document does not indicate country of origin of the data beyond the company's location (Memphis, TN, USA). It is a prospective test in the sense that new components were manufactured and tested according to a protocol.

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

• Ground Truth for Test Set: The "ground truth" in this context is the mechanical performance standards and specifications that the predicate devices meet. These are established through recognized industry standards (e.g., ASTM, ISO for medical implants) and regulatory requirements for spinal implants.
• Experts and Qualifications: The document does not specify the number or qualifications of experts involved in establishing these mechanical standards. These would typically be biomedical engineers, materials scientists, and regulatory experts. The FDA's review process (implied by the 510(k) clearance) involves regulatory and engineering experts who evaluate the submitted test data against these established standards.

4. Adjudication Method for the Test Set

• Adjudication Method: For mechanical testing, adjudication typically involves comparison of the test results against predefined acceptance criteria/specifications. If the results fall within the acceptable range and demonstrate equivalence to the predicate, it is considered successful. There is no "adjudication method" in the sense of multiple human readers independently assessing medical images; rather, it's objective measurement comparison.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases. The VERTE-STACK® Spinal System is an implantable surgical device, and its clearance relies on mechanical and material equivalence rather than diagnostic performance assessed by human readers.

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

• No, a standalone (algorithm only) performance study was not done. This is also not applicable to an implantable surgical device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is primarily objective mechanical performance specifications and regulatory standards for spinal intervertebral body fixation orthoses. The demonstration is that the modified device's mechanical properties align with those of previously cleared, substantially equivalent devices. This is not pathology, outcomes data, or expert consensus on a clinical outcome for this type of submission.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This concept is not applicable to the VERTE-STACK® Spinal System submission. "Training set" refers to data used to train an AI algorithm. This device is a physical implant, not an AI or diagnostic software.

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

• Ground Truth for Training Set Establishment: This concept is not applicable as there is no AI algorithm training set involved in this submission.

Ask a specific question about this device

The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

The VERTE-STACK® device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK® device is fabricated and manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT1) along with either titanium or tantalum markers. Alternatively the entire device may be manufactured from titanium alloy.

The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

The provided documentation for the VERTE-STACK® Spinal System (K060719) does not contain information about acceptance criteria or a study proving device performance against such criteria.

This 510(k) summary is for a spinal intervertebral body fixation orthosis. The purpose of the submission is to include slightly modified components to a previously cleared system. It focuses on demonstrating substantial equivalence to predicate devices.

Therefore, I cannot populate the requested table or answer the questions regarding acceptance criteria and performance studies. The document only describes the device, its indications for use, and establishes substantial equivalence based on prior 510(k) clearances.

Ask a specific question about this device

The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

The VERTE-STACK® device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK® device is fabricated and manufactured from POLYETHERETONE (PEEK OPTIMA LT1) along with either titanium or tantalum markers. Alternatively the entire device may be manufactured from titanium alloy.

The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission is to include slightly modified components to the previously cleared VERTE-STACK® Spinal System.

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) summary for the VERTE-STACK® Spinal System, which is a medical device. It describes the product, its indications for use, and its substantial equivalence to previously cleared devices.

The information you are asking for, such as acceptance criteria, specific study details (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), and training set details, are typically found in detailed clinical trial reports or validation studies, which are not part of this 510(k) summary. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on new performance studies.

Ask a specific question about this device

The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

The VERTE-STACK® device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK® device is fabricated and manufactured from POLYETHERETHERKETCNE (PEFK OPTIMA LT) along with a tantalum marker. Alternatively the device may be manufactured from titanium alloy.

The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission is to include additional components (VERTE-STACK® CRESCENT™) to the previously cleared VERTE-STACK® Spinal System.

This looks like a 510(k) summary for a medical device (VERTE-STACK® Spinal System), which is a premarket notification to the FDA. These documents primarily focus on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria for a new AI/algorithm-based diagnostic or clinical decision support system.

Therefore, the provided document DOES NOT contain the kind of information requested regarding acceptance criteria and a study proving device performance for an AI/algorithm-based device.

The document describes a physical spinal implant and its components. The "proof" for this type of device typically comes from:

• Substantial Equivalence (SE): Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is the core of a 510(k) submission. The document explicitly states this in section V.
• Mechanical Testing: Bench testing and material characterization to ensure the device meets engineering specifications for strength, durability, biocompatibility, etc. This is usually summarized or referenced, but specific acceptance criteria and detailed study results are generally not in the 510(k) summary itself.

In summary, because this is a 510(k) submission for a physical spinal implant, it does not include the information you're asking for about acceptance criteria and a study proving performance in the context of an AI/algorithm-driven device.

If this were a document for an AI-based device, the sections you've outlined would be critical. However, this specific document does not lend itself to those questions.

Ask a specific question about this device

The VERTE-STACK™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). The VERTE-STACK™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

The VERTE-STACK™ device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK™ device is fabricated and manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT) along with a tantalum marker. Alternatively the device may be manufactured from titanium alloy.

The design of the VERTE-STACK™ device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient anatomy.

The VERTE-STACK™ device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK™ constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK™ constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission is to include slightly modified components to the previously cleared VERTE-STACK™ Spinal System.

This 510(k) Summary for the VERTE-STACK™ Spinal System describes a medical device submission, not a study evaluating device performance against acceptance criteria in the typical sense of a clinical or analytical study for new AI/diagnostic devices.

Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable or available within this document.

This document is a regulatory submission focused on demonstrating substantial equivalence to a previously cleared device, not on proving clinical efficacy or diagnostic accuracy through a new study.

Here's how to interpret the provided information in the context of your request:

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

• Not Applicable. This document does not describe performance criteria for a study. The acceptance criterion for this submission is "substantial equivalence" to a predicate device.

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. No test set or data provenance is mentioned as this is a device modification for substantial equivalence, not a new performance study.

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. No ground truth establishment by experts is described.

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

• Not Applicable. No adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI/diagnostic device, and no MRMC study was conducted.

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

• Not Applicable. This is not an AI/diagnostic device, and no standalone performance study was conducted.

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

• Not Applicable. No ground truth is mentioned.

8. The sample size for the training set

• Not Applicable. No training set is mentioned.

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

• Not Applicable. No training set or ground truth establishment is mentioned.

Summary of the document's relevance to "acceptance criteria" and "study":

The "acceptance criteria" for this submission were met by demonstrating substantial equivalence to an already cleared device (K041452). This means that the modified components of the VERTE-STACK™ Spinal System were deemed to have the same intended use, technological characteristics, and safety/effectiveness profile as the previously cleared version. The "study" described is essentially the process of submitting documentation to the FDA to prove this substantial equivalence, rather than a clinical trial or performance evaluation.

Ask a specific question about this device

The VERTE-STACK™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK™Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, the Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

The VERTE-STACK™ device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK ™ device is fabricated and manufactured from titanium alloy. Alternatively the device may be manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT) and includes a tantalum marker.

The design of the VERTE-STACK™ device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient anatomy.

The VERTE-STACK™ device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK™ constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK™ constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission is to offer a titanium version of the previously cleared VERTE-STACK™ Spinal System components.

The provided text is a 510(k) summary for the VERTE-STACK™ Spinal System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving the acceptance criteria of a novel device through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not applicable or not present in this document.

Here's an analysis of the available information:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. 510(k) summaries for spinal implants typically focus on demonstrating mechanical and material equivalence to existing devices, along with similar indications for use. They do not usually include acceptance criteria and performance data in the way a clinical trial for a diagnostic device or a new therapeutic device might.

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

This information is not provided as there is no specific "test set" or clinical study described in terms of patient data. The submission relies on establishing substantial equivalence to previously cleared devices (K041556 and K040422).

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

This information is not provided. As there's no clinical test set for diagnostic performance, ground truth establishment by experts is not applicable here.

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

This information is not provided as there is no clinical test set with an adjudication process described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and not provided. This device is a spinal implant, not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to its approval.

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

This information is not applicable and not provided. This device is a physical implant, not an algorithm.

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

This information is not applicable and not provided. For a spinal implant 510(k), "ground truth" in the clinical sense of diagnostic accuracy is not the primary focus. The "truth" in this context revolves around demonstrating the material properties, mechanical performance, and biomechanical equivalence to predicate devices, often through bench testing and engineering analysis rather than human ground truth.

8. The sample size for the training set:

This information is not provided. The concept of a "training set" is typically associated with machine learning or AI algorithm development, which is not relevant to this medical device submission.

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

This information is not applicable and not provided for the same reasons as in point 8.

Summary of what the document does indicate:

The submission focuses on demonstrating substantial equivalence of a titanium version of the VERTE-STACK™ Spinal System to previously cleared VERTE-STACK™ Spinal System components (K041556 and K040422). This means that the device is considered safe and effective because it is similar to devices already on the market. The basis for approval is that the new titanium version shares similar design, materials (with the exception of the specific titanium versus PEEK), intended use, and performance characteristics with the predicate devices. The document highlights:

• Product Description: A stackable spacer for vertebral body replacement in the anterior thoracic and lumbar spine, made from titanium alloy (previously PEEK OPTIMA LT was also an option).
• Intended Use: Thoracolumbar spine (T1-L5) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma, always used with supplemental fixation and bone graft.
• Substantial Equivalence: Documentation was provided demonstrating equivalence to K041556 and K040422. This is the "study" alluded to, but it's a comparison to predicates, not a clinical trial with acceptance criteria for device performance in patients.

In essence, this 510(k) summary is not a report of a clinical study designed to meet specific performance acceptance criteria for a novel device, but rather a regulatory filing asserting similarity to existing approved devices.

Ask a specific question about this device