(89 days)
The T2TM 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 end caps 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 XVBRTM 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 T2TM Spinal System construct is intended to be used with allograft and/or autograft.
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 TM Spinal System contains an expandable centerpiece, which is made of titanium alloy, cobait chrome, and nitinol and is available in multiple diameters and heights to accommodate the patient's anatomical requirements. The T2™ Spinal System's end caps are attached to the T2™ Spinal System's expandable centerpieces to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.
T2TM 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.
The provided text K091883 for the T2™ Spinal System describes a medical device, its intended use, and its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or any other details related to proving the device meets specific performance criteria.
This document is a 510(k) summary, which is typically focused on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and safety and effectiveness. It often refers to prior clearances and may not detail new, independent performance studies beyond what was sufficient for proving substantial equivalence.
Therefore, I cannot provide the requested information from the given text.
The following information is missing from the provided document:
- Table of acceptance criteria and reported device performance: This document does not specify any quantitative acceptance criteria or provide performance data against such criteria.
- Sample size used for the test set and data provenance: No test sets or their characteristics are mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no test sets are described.
- Adjudication method for the test set: Not applicable as no test sets are described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No mention of an MRMC study or effect size.
- Standalone (algorithm-only) performance: Not applicable as this is a physical spinal system, not an algorithm.
- Type of ground truth used: Not applicable as no performance studies are detailed.
- Sample size for the training set: Not applicable as no training sets are described for an algorithm.
- How the ground truth for the training set was established: Not applicable as no training sets are described for an algorithm.
§ 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.