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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 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

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 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 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 modified versions of the previously cleared VERTE-STACK™ Spinal System components.

This document is a 510(k) summary for the VERTE-STACK™ Spinal System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting de novo clinical study results against predefined acceptance criteria.

Therefore, I cannot answer your request based on the provided text. The document does not include:

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

The core of this document is to establish substantial equivalence for modifications to an existing device, as stated in section V: "Documentation was provided which demonstrated the VERTE-STACK™ Spinal System to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System (K030736, SE 04/02/03)."

Ask a specific question about this device

The VERTE-STACKTM 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 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 to the previously cleared VERTE-STACK™ Spinal System.

This 510(k) summary (K041556) describes a conventional spinal implant system, the VERTE-STACK™ Spinal System. For this type of device, performance is typically assessed through substantial equivalence to predicate devices, mechanical testing, and biocompatibility, rather than clinical studies involving human readers or AI.

Therefore, the following information regarding acceptance criteria, study details, and expert involvement for AI/human reader performance studies is not applicable to this submission. The device's acceptance is based on its similarity to previously cleared devices (predicates) and its ability to meet established material and mechanical standards.

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

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

Not applicable. This device's clearance relied on substantial equivalence and non-clinical testing, not a test set of patient data for performance evaluation in the context of AI or human reading.

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

Not applicable. Ground truth for clinical interpretation or AI performance was not established as part of this submission. The "ground truth" for this device relates to its material properties, mechanical integrity, and design features conforming to established standards for spinal implants.

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

Not applicable. No test set requiring expert adjudication for clinical evaluations was mentioned in the provided text.

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

Not applicable. This device is a physical surgical implant, not a diagnostic or AI-assisted interpretation tool. Therefore, MRMC studies are not relevant.

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

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

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

The "ground truth" implicitly referred to for this type of device includes:

• Engineering consensus and established industry standards for material strength, biocompatibility, and mechanical properties.
• Regulatory definitions and requirements for spinal intervertebral body fixation orthoses.
• Data supporting the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this device's evaluation is not based on machine learning.

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

Not applicable. No training set was used.

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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 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 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 VERTF-STACK™ constructs may not be used with stainless steel supplemental fixation devices. The purpose of this submission is to include additional components to the previously cleared VERTE-STACK™ Spinal System.

The provided text is a 510(k) summary for the VERTE-STACK™ Spinal System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with acceptance criteria and device performance results as typically seen for AI/ML-based medical devices or diagnostics.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided document. The 510(k) summary is a regulatory submission demonstrating that a new device is as safe and effective as an existing, legally marketed device (predicate device). It does not typically include detailed performance studies with acceptance criteria in the way a clinical trial or a study for a novel device would.

The document states:
"Documentation was provided which demonstrated the VERTE-STACK™ Spinal System to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System components found in K030736, K030735, K023570 and K021791."

This means the acceptance criteria and performance are implicitly met by virtue of being similar enough to established predicate devices that have already undergone regulatory scrutiny. No new clinical or performance studies are detailed in this summary.

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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 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 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 corpoctomy. 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 for the VERTE-STACK™ Spinal System (K040536) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

Instead, this document is a regulatory submission for a medical device that demonstrates substantial equivalence to a previously cleared device. Substantial equivalence is the primary pathway for medical device approval in the U.S. when a new device is similar enough to an existing legally marketed device (predicate device).

Here's why the requested information is absent and what this document does provide:

1. Acceptance Criteria and Reported Device Performance: This document does not include performance metrics (like sensitivity, specificity, accuracy) or acceptance criteria for such metrics because it's not a clinical trial report or a study evaluating a diagnostic or predictive algorithm. The "performance" being assessed here is the device's functional and safety characteristics compared to its predicate.

2. Sample Size for Test Set and Data Provenance: Not applicable. There is no "test set" in the sense of a dataset for evaluating an algorithm's performance. The "testing" involved would typically be mechanical, biocompatibility, and sterilization testing to ensure the device itself meets established standards and is equivalent to the predicate. Such details are usually summarized but not presented with raw data in the 510(k) summary itself.

3. Number of Experts for Ground Truth and Qualifications: Not applicable. Ground truth, in the context of diagnostic or predictive algorithms, refers to the true medical condition or outcome. This device is an implantable spinal system, not a diagnostic tool requiring expert interpretation of images or data to establish ground truth.

4. Adjudication Method: Not applicable for the same reasons as above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is relevant for evaluating human reader performance with and without AI assistance, which is not the purpose of this device.

6. Standalone Performance Study: Not applicable. This type of study is for evaluating an algorithm's performance independent of human input. The VERTE-STACK™ is a physical medical implant.

7. Type of Ground Truth Used: Not applicable.

8. Sample Size for Training Set: Not applicable. There is no algorithm being trained.

9. How Ground Truth for Training Set was Established: Not applicable.

What the document does indicate regarding "equivalence" and "purpose":

• Substantial Equivalence (Section V): The core of this submission is to demonstrate that the VERTE-STACK™ Spinal System is substantially equivalent to a previously cleared device, VERTE-STACK™ Spinal System K030601 (cleared on March 25, 2003). This means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
• Product Description (Section III): The device is a "stackable spacer" for vertebral body replacement, made from PEEK OPTIMA LT or titanium alloy, and used with supplemental fixation. The purpose of this specific submission (K040536) is "to include a modified version of previously cleared VERTE-STACK™ Spinal System BOOMERANG™ PEEK components." This implies that the modifications were minor enough not to require a completely new evaluation, but still necessitated demonstrating equivalence.
• Indications for Use (Section IV and Enclosure): The device is 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), always with supplemental fixation and bone graft.
• Regulatory Conclusion: The FDA's letter (K040536) confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed under general controls.

In summary, this 510(k) pertains to a physical medical implant device and not a diagnostic or AI algorithm. Therefore, the requested information regarding acceptance criteria and performance studies in the context of AI or diagnostic accuracy is not present in this type of regulatory submission. The "study" here is the comparison to a predicate device, demonstrating equivalent safety and effectiveness through design, materials, and intended use.

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