(134 days)
The SeaSpine VBR System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The SeaSpine VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the SeaSpine VBR System is intended for use with bone graft.
The SeaSpine VBR System straight, curved, round, and trapezoidal VBRs are manufactured out of PEEK OPTIMA® polymer with tantalum wires and/or beads. All VBR configurations will be offered in numerous lengths and sizes. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The SeaSpine VBR System will offer a wide variety of instruments that range from paddle scrapers to inserters. These various instruments will be made primarily from stainless steel with handles made from Radel or Pomalux. These items are supplied "NON-STERILE" and must be sterilized prior to use.
The SeaSpine VBR System is a medical device for vertebral body replacement, and its acceptance criteria and the study proving it meets these criteria are outlined in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SeaSpine VBR System are based on demonstrating "substantial equivalence" to its predicate devices. This is not about specific numerical performance metrics in the way a diagnostic AI might have, but rather about demonstrating that the new device is as safe and effective as existing legally marketed devices with similar intended use and technological characteristics.
| Feature | Acceptance Criteria (Substantial Equivalence to Predicate Devices) | Reported Device Performance (SeaSpine VBR System) |
|---|---|---|
| Intended Use | The intended use should be substantially equivalent to predicate devices for spinal disorders and fusion. | "The intended use of the SeaSpine VBR System is as a vertebral body replacement to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur." (Determined "Yes" to be substantially equivalent to predicates) |
| Indications for Use | Indications for use (Trauma/fracture, Tumor) should be substantially equivalent to predicate devices. | "• Trauma/fracture • Tumor" (Determined "Yes" to be substantially equivalent to predicates) |
| Design | Design (PEEK implants with tantalum markers, multiple shapes) should be substantially equivalent. | "• PEEK implants with tantalum markers • Multiple shapes" (Determined "Yes" to be substantially equivalent to predicates) |
| VBR Shapes/Sizes | Straight, Curved, Round, and Trapezoidal VBRs in various sizes should be substantially equivalent. | "Various sizes" for each shape (Determined "Yes" to be substantially equivalent to predicates) |
| Material | Material (PEEK and Tantalum) should be substantially equivalent. | "PEEK and Tantalum" (Determined "Yes" to be substantially equivalent to predicates, acknowledging predicate devices use Titanium per ASTM F-1108) |
| Sterile | Sterilization status (Non-sterile) should be substantially equivalent. | "Non-sterile" (Determined "Yes" to be substantially equivalent to predicates which included both sterile and non-sterile options) |
| Mechanical Testing | Conducted according to recognized standards, results substantially equivalent to predicate devices. | "Conducted according to recognized standards" (Determined "Yes" to be substantially equivalent to predicates) |
| Method of Sterilization | (High-temperature steam) should be substantially equivalent. | "High-temperature steam" (Determined "Yes" to be substantially equivalent to predicates) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) premarket notification for a medical device (spinal implant), not an AI/ML algorithm. Therefore, there is no "test set" in the context of diagnostic performance data, nor is there data provenance (e.g., country of origin, retrospective/prospective) related to patient data or diagnostic images. The "study" mentioned refers to the mechanical testing and comparison of the device's characteristics to already legally marketed predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As this is a 510(k) for a physical medical device (spinal implant) and not an AI/ML diagnostic system, there is no "ground truth" established by experts in the context of diagnostic accuracy for a test set. The "ground truth" for the device's safety and effectiveness is established by its similarity to predicate devices that have already been cleared by the FDA and have a history of safe use.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring expert adjudication for diagnostic performance is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is designed for evaluating the diagnostic performance of AI-assisted systems versus human readers. This submission is for a physical medical device (spinal implant) and does not involve such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness profile of legally marketed predicate devices. The SeaSpine VBR System demonstrated its "ground truth" by showing substantial equivalence in design, materials, intended use, indications for use, and mechanical testing results to these predicate devices.
8. The Sample Size for the Training Set
Not applicable. This submission is not for an AI/ML algorithm. There is no concept of a "training set" in the context of device design and mechanical testing for spinal implants.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no process for establishing its ground truth.
§ 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.