(62 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 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:
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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. -
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.
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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.
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Adjudication method for the test set:
- Not applicable. No test set requiring adjudication in the AI/ML context.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm/AI device.
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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).
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The sample size for the training set:
- Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
§ 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.