(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.
§ 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.