(30 days)
The T2™ Spinal System is a vertebral body replacement system 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 T2TM components consist of a series of end caps, baskets, and covers which must be attached to a T2 XVBR™ expanding centerpiece to form a complete construct. The final construct is to be used with supplemental fixation. The T2 SCEPTOR™ components also serve as a vertebral body replacement device for the same intended use in the thoracolumbar spine. The T2 SCEPTOR™ end caps and endcleats must be attached to a PYRAMESH-C® device to form a complete construct. Both constructs (T2 XVBR™ and T2 SCEPTOR™) must be used with supplemental fixation to form a final construct. Specifically, the construct is to be used with the Medtronic ZPLATE IITM Anterior Fixation System, the DYNALOK CLASSIC® Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, or their successors. Additionally, the T2™ Spinal System construct is intended to be used with bone graft.
The T2TM Spinal System is a distractible system used in corpectomy procedures. This construct is inserted between two vertebral bodies in the thoracic and/or lumbar spine and is expanded to aid in the surgical correction and stabilization of the spine. The construct is not intended to be used as a stand alone device. The construct is intended to be used with either anterior and/or posterior supplemental spinal fixation systems already cleared for thoracic and lumbar spine stabilization.
The T2 XVBR™ expanding cage is made of titanium alloy, cobalt chrome, and nitinol. The T2 XVBR™ end caps, baskets, and covers are attached to the T2 XVBR™ expanding cage to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.
T2™ Spinal System constructs may not be used with stainless steel supplemental fixation devices. Titanium constructs comprised from one of the following Medtronic spinal systems or their successors must be used with the T2TM Spinal System.
This document is a 510(k) summary for the T2™ Spinal System, which is a medical device. Based on the provided text, it's not a study proving device performance against acceptance criteria in the typical sense of a clinical or analytical performance study for an AI/diagnostics device. Instead, it's a submission to demonstrate substantial equivalence to previously cleared devices. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This document is a 510(k) submission asserting substantial equivalence to predicate devices, not a performance study against specific acceptance criteria. The "performance" being demonstrated is the T2™ Spinal System's similarity in intended use, technology, and safety/effectiveness to existing devices.
2. Sample size used for the test set and the data provenance
Not applicable. No test set or data provenance related to a performance study is described. The submission is based on comparison to predicate devices, material testing, and design specifications.
3. 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 for a test set is described.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is described.
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 device is a physical spinal implant, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical spinal implant, not an algorithm.
7. The type of ground truth used
Not applicable. No ground truth as typically understood for a performance study is described. The basis for clearance is "Substantial Equivalence" to legally marketed predicate devices, meaning the device's design, materials, and intended use are comparable to already approved devices.
8. The sample size for the training set
Not applicable. No training set is described.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for it is described.
Summary of the K082112 510(k) Pre-market Notification (T2™ Spinal System):
This document is a 510(k) summary for a vertebral body replacement system. The core of this submission is to demonstrate substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, based on similarities in intended use, technological characteristics, and performance (often demonstrated through bench testing and material compatibility, though not detailed here).
The FDA's letter (pages {2} and {3}) confirms that a substantial equivalence determination was made, allowing the device to be marketed. This regulatory pathway does not typically involve a clinical performance study with acceptance criteria and a test set like those for AI or diagnostic devices. Instead, the "proof" is in the successful demonstration of equivalence to existing, approved devices.
§ 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.