Search Results
Found 9 results
510(k) Data Aggregation
(55 days)
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
(25 days)
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:
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Demonstrated) |
|---|---|
| Same Intended Use: Device must have the same intended use as legally marketed predicate devices. | The VERTE-STACK® Spinal System has the same indications for use as previously cleared VERTE-STACK® components (K061938) and the CD HORIZON® Spinal System (K061304). |
| Similar Technological Characteristics: Device must have similar technological characteristics as legally marketed predicate devices. | The product description notes that the components are made of medical grade PEEK-OPTIMA LT1 with Tantalum or titanium markers, or titanium alloy, which aligns with materials typically used in predicate spinal systems. The design for various lengths, diameters, and angulations for individual patient pathology suggests consistency with established spinal implant design principles. |
| Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety and effectiveness, or demonstrate that the device is as safe and effective as the legally marketed predicate device. | The submission primarily focused on modifying the wording of the package insert, specifically removing certain contraindications and including a "NOTA BENE" for potential factors. The document states this re-wording makes it "more consistent with that of the package insert for the CD HORIZON® Spinal System." This implies that the device's safety and effectiveness were already established with the predicate device and that the label change does not alter this, but rather clarifies usage. |
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
(24 days)
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
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Summary from submission) |
|---|---|
| Mechanical Equivalence: The modified device's mechanical properties (e.g., strength, stability) are comparable to the predicate devices. | "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 (K060719, SE 4/12/2006; and K052931, SE 11/13/2005)." |
| Material Equivalence: The materials used are equivalent or acceptable for the intended use and consistent with predicate devices. | "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." (This implies a comparison and acceptance of these materials relative to the predicate.) |
| Indications for Use Equivalence: The intended use of the modified device is the same as the predicate devices. | The Indications for Use section is identical to indications likely associated with the predicate devices. (Not explicitly stated as "equivalent" but presented as existing indications). |
| Design Integrity: Modifications (geometry, additional sizes) do not negatively impact safety or effectiveness compared to predicate. | "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 approval indicates these changes were acceptable and did not compromise equivalence). |
| Compatibility: The device maintains compatibility with specified supplemental fixation systems. | "The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System... and/or their successors." (Compatibility is implicitly accepted if substantial equivalence is granted). |
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
(30 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Equivalence to legally marketed predicate devices (K060719, K052931, K030736). This implies meeting the same mechanical strength, durability, and functional requirements. | 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. |
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
(23 days)
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 I.T) 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 1M 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 titanium components to the VERTE-STACK™ Spinal System.
This appears to be a 510(k) premarket notification document for a medical device, specifically the VERTE-STACK™ Spinal System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with acceptance criteria and performance metrics of the new device itself in the way that an AI/ML device would.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in the provided document.
Here's why and what can be extracted from the provided text:
- Device Type: The VERTE-STACK™ Spinal System is a physical medical implant (spinal intervertebral body fixation orthosis), not an AI/ML diagnostic or prognostic software. Substantial equivalence for physical implants typically relies on mechanical testing, material compatibility, and engineering design comparisons to predicate devices, rather than clinical performance metrics in the way AI algorithms are evaluated.
- Submission Type: A 510(k) submission, as indicated by "K040167" and the FDA letter, aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process generally does not require new efficacy or comparative effectiveness studies with human readers, especially for a device of this nature. The FDA letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".
Information that can be extracted from the document related to the device and its regulatory context:
- Device Name: VERTE-STACK™ Spinal System
- Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060)
- Regulatory Class: II
- Product Code: MQP
- Manufacturer: Medtronic Sofamor Danek Company
- Device Description: Stackable spacer made from PEEK OPTIMA I.T. (with a tantalum marker) or titanium alloy, designed for vertebral body replacement in the anterior thoracic and lumbar spine. It is not intended as a stand-alone device and must be used with additional anterior and/or posterior spinal instrumentation.
- Indications for Use: Vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Must be used with supplemental fixation systems (listed are Medtronic Sofamor Danek ZPLATE II, DYNALOK™ CLASSIC, VANTAGE™, TSRH®, CD HORIZON®, GDLH® Spinal System, or their successors) and bone graft.
- Purpose of Submission K040167: To include titanium components to the VERTE-STACK™ Spinal System.
Conclusion:
The provided document (a 510(k) premarket notification) for the VERTE-STACK™ Spinal System does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or adjudication methods for demonstrating device performance. These types of detailed studies are not typically required for a 510(k) submission of a physical implant device demonstrating substantial equivalence.
Ask a specific question about this device
(50 days)
The VERTE-STACKTM 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, Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System, the Titanium 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 PEEK 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) as described by ASTM F2026. The tantalum marker used for this product is made to the voluntary standard of ASTM F-560.
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 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.
The purpose of this submission is to add modified components to the VERTE-STACK™ Spinal System.
The provided document is a 510(k) summary for the VERTE-STACK™ Spinal System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and performance study results as if for a novel device. Therefore, much of the requested information (e.g., specific performance metrics, sample sizes for test/training sets, expert qualifications) is not available in this type of submission.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The VERTE-STACK™ Spinal System was found to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System (K023570 and K021791). |
| Intended Use | The device is intended for vertebral body replacement in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (fracture). |
| Material Composition | Fabricated from POLYETHERETHERKETONE (PEEK OPTIMA LT) as described by ASTM F2026. The tantalum marker is made to ASTM F-560. |
| Design | Stackable PEEK spacer, available in various sizes and heights to suit individual patient pathology. Can be used individually or stacked. |
| Compatibility with Supplemental Fixation | Must be used with additional anterior and/or posterior spinal instrumentation from specific Medtronic Sofamor Danek systems (e.g., ZPLATE II, DYNALOK™ CLASSIC, VANTAGE™, TSRH®, CD HORIZON®, GDLH®). |
| Use with Bone Graft | Intended to be used with bone graft. |
2. Sample size used for the test set and the data provenance
- Not applicable/Not provided. This 510(k) summary primarily addresses substantial equivalence based on design, materials, and indications for use compared to predicate devices, rather than clinical performance data from a specific test set. There is no mention of a test set being used to evaluate performance against specific acceptance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The concept of "ground truth" established by experts for a test set is not relevant for this type of 510(k) submission, which focuses on device design and equivalence.
4. Adjudication method for the test set
- Not applicable/Not provided. No test set or adjudication method is described in this submission.
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/Not provided. This device is a physical spinal implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided. The "ground truth" in this context would implicitly refer to the established safety and effectiveness of the predicate devices based on their prior clearances and clinical experience. The submission relies on the concept of "substantial equivalence" to these known, safe, and effective devices.
8. The sample size for the training set
- Not applicable/Not provided. This is not a machine learning device, so the concept of a "training set" is not relevant.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, no training set is relevant.
Ask a specific question about this device
(23 days)
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, the Titanium 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 PEEK 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) as described by ASTM F-1579. The tantalum marker used for this product is made to the voluntary standard of ASTM F-560.
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 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.
The purpose of this submission is to include additional components to the VERTE-STACK™ Spinal System.
The provided 510(k) summary for the VERTE-STACK™ Spinal System (K030736) is a premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not typically found in a 510(k) summary like this.
Here's why and what can be inferred:
- Acceptance Criteria & Device Performance: The document does not specify quantitative acceptance criteria (e.g., specific thresholds for strength, durability, or clinical outcomes) or report device performance against such criteria. Instead, it states the device is "substantially equivalent" to previously cleared VERTE-STACK™ Spinal Systems (K023570 and K021791).
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): Since the primary claim is substantial equivalence, a detailed clinical study with the elements listed is generally not required for a 510(k). This particular submission states its purpose is "to include additional components to the VERTE-STACK™ Spinal System," implying modifications or additions to an already cleared design. Demonstrating substantial equivalence typically relies on comparing design, materials, indications for use, and technological characteristics to an already legally marketed device, often through bench testing and sometimes non-clinical testing, rather than extensive human clinical trials.
Conclusion based on the provided document:
No information regarding acceptance criteria, detailed study design, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance studies, or how ground truth was established for such studies is present in this 510(k) summary. The device's "performance" is implicitly deemed acceptable because it is substantially equivalent to predicate devices that have already met regulatory requirements.
Ask a specific question about this device
(28 days)
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, the Titanium 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 PEEK 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) as described by ASTM F-1579. The tantalum marker used for this product is made to the voluntary standard of ASTM F-560.
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 mav be used individually. or two or more mav 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.
The purpose of this submission is to include additional sizes to the VERTE-STACK™ Spinal System.
This 510(k) premarket notification for the VERTE-STACK™ Spinal System describes a device that is substantially equivalent to previously cleared devices. Therefore, it does not present new acceptance criteria or a study demonstrating device performance against new criteria. Instead, the submission relies on the established equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided text, indicating where information is not applicable or not provided for an equivalence submission:
Acceptance Criteria and Study for VERTE-STACK™ Spinal System (K030601)
This submission (K030601) is a 510(k) premarket notification claiming substantial equivalence to previously cleared VERTE-STACK™ Spinal System devices (K023570 and K021791). In such an application, the primary "acceptance criterion" is generally demonstrating that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness, compared to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as demonstrated by equivalence to predicates) |
|---|---|
| Intended Use: Replace collapsed, damaged, or unstable vertebral body due to tumor or trauma in T1-L5 with supplemental fixation and bone graft. | The VERTE-STACK™ Spinal System (K030601) has the same indications for use as the predicate VERTE-STACK™ Spinal Systems (K023570 and K021791). |
| Technological Characteristics: PEEK spacer, stackable, used with specified spinal instrumentation and bone graft. | The VERTE-STACK™ Spinal System (K030601) is fundamentally the same design as the predicate, made from PEEK OPTIMA LT and Tantalum markers. The submission's purpose is to include additional sizes, implying similar manufacturing processes and materials, and thus similar performance to the existing line. |
| Material Biocompatibility: PEEK OPTIMA LT (ASTM F-1579) and Tantalum (ASTM F-560). | The device is fabricated from PEEK OPTIMA LT (ASTM F-1579) and uses Tantalum markers (ASTM F-560), identical to or consistent with materials likely used in the predicate devices, which are accepted standards. |
| Mechanical Performance/Structural Integrity: Ability to withstand loads in the anterior thoracic and lumbar spine when used with supplemental fixation. | Not explicitly detailed in this document, but substantial equivalence implies that the mechanical properties of the new sizes are consistent with the safety and effectiveness of the previously cleared predicate devices. Typically, mechanical testing (e.g., compression, torsion, bending) demonstrating compliance with relevant ASTM or ISO standards would have been performed for the original predicate devices. The addition of new sizes would likely involve demonstrating that these new sizes also meet the same mechanical performance expectations. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable / Not provided. This is a substantial equivalence claim based on the device's design, materials, and intended use being similar to existing cleared devices. It does not involve a clinical study with a distinct "test set" of patients or data in the way an AI/software device would. The "test" is the comparison to the predicate device and relevant standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable / Not provided. Given that this is a product submission for a physical medical device (spinal implant) based on substantial equivalence, there is no "ground truth" derived from expert interpretation of data in the manner of an AI diagnostic device. The "ground truth" is typically established by engineering design, material specifications, and performance testing against recognized standards.
4. Adjudication Method for the Test Set
- Not applicable / Not provided. As there is no "test set" in the context of expert review for diagnostic accuracy, no adjudication method is relevant 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. This submission is for a physical spinal implant, not an AI or software-as-a-medical-device (SaMD). Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm or software.
7. The Type of Ground Truth Used
- Engineering Specifications and Standard Compliance: The "ground truth" for this type of device relies on established engineering principles, material specifications (e.g., ASTM F-1579 for PEEK, ASTM F-560 for Tantalum), and a demonstration that the device's design and intended performance are safe and effective, typically through mechanical testing and validation of material properties. For a substantial equivalence claim, the primary "ground truth" is the previously cleared predicate devices and the accepted safety and effectiveness established for them.
8. The Sample Size for the Training Set
- Not applicable / Not provided. This is not an AI/ML device where a training set size would be relevant. The "training" for such a device is in its design, manufacturing processes, and adherence to quality systems.
9. How the Ground Truth for the Training Set was Established
- Not applicable / Not provided. There is no "training set" in the context of an AI/ML workflow. For a physical device, the "ground truth" for its design and manufacturing is established through adherence to recognized standards, quality control, and pre-clinical testing that establishes its safety and performance characteristics.
Ask a specific question about this device
(87 days)
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, Titanium DYNALOK™ CLASSIC Spinal System, Laurain DeWald Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System, the Titanium 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 PEEK 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) as described by ASTM F-1579. The Tantalum marker used for this product is made to the voluntary standard of ASTM F-560. The VERTE-SPAN™ components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability
This is a 510(k) summary for a medical device (VERTE-STACK™ Spinal System), not a study analyzing AI/algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance metrics is not applicable to this document.
The document describes a spinal implant and its substantial equivalence to previously cleared devices. It does not contain any information about an algorithm, AI, or a study to prove device performance in the context of diagnostic or treatment algorithms.
However, I can extract information related to the device itself:
1. Table of "Acceptance Criteria" and Reported Device Performance:
The document doesn't present "acceptance criteria" in the typical sense of a pre-defined performance metric for an AI or diagnostic algorithm. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" described is in terms of the device's design, materials, and intended use matching those of already approved devices.
| Acceptance Criterion (Implied via Substantial Equivalence) | Reported Device Performance (VERTE-STACK™) |
|---|---|
| Material Composition | Fabricated from PEEK OPTIMA LT (ASTM F-1579) and Tantalum marker (ASTM F-560) |
| Intended Use | Vertebral body replacement in thoracolumbar spine (T1-L5) due to tumor or trauma (fracture) |
| Use with Supplemental Fixation | Must be used with additional anterior and/or posterior spinal instrumentation |
| Compatibility with Specific Systems | To be used with listed Medtronic Sofamor Danek fixation systems or their successors, and bone graft |
| Design/Configuration | Stackable PEEK spacer, rigidly lockable into various configurations |
| Clinical Efficacy/Safety | Implied by substantial equivalence to predicate devices (VERTE-SPAN™ Spinal System, DePuy AcroMed Stackable Cage System, OEC/Rezaian Spinal Fixator, Osteotech Vertebral Body Replacement device, PYRAMESH®-C Implant System) which have established safety and efficacy. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document is about a physical medical device, not an AI or algorithm. There is no "test set" in the context of data for an algorithm. The evidence for substantial equivalence is based on comparisons of design, materials, and indications for use against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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. There is no AI or algorithm involved in this submission.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable as a "ground truth" for an algorithm. The "truth" in this context is the regulatory acceptance of predicate devices based on their established material properties, design, and clinical performance, all of which would have been supported by previous submissions (e.g., mechanical testing, potentially animal or limited human clinical data for the original predicates, and extensive literature on spinal fusion principles).
8. The sample size for the training set:
- Not Applicable. There is no algorithm training set.
9. How the ground truth for the training set was established:
- Not Applicable. There is no algorithm training set.
In summary: This document is a regulatory submission for a physical medical implant (VERTE-STACK™ Spinal System) demonstrating substantial equivalence to pre-existing, legally marketed devices. It does not involve any AI, algorithms, or studies of their performance.
Ask a specific question about this device
Page 1 of 1