(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.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.