(196 days)
The Tension Band Anterior Spinal System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T7 to L5. The TBA Spinal System is intended to provide stabilization of a spinal segment(s) as an adjunct to spinal fusion. Indications for the use of this device include trauma, spinal stenosis, deformities or curvatures (e.g., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Tension Band Anterior (TBA) Spinal System includes rods, hooks, wedges, and bone (vertebral) and lockdown screws. A single rod diameter and a range of hook sizes with size-matched bone screws are available. Wedges and lockdown screws serve as the interconnection mechanism.
This document, K071151, describes the Tension Band Anterior Spinal System, a spinal implant. There is no information provided within the text about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and study results for a new device's performance.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set specifics, as this information is not present in the provided text.
The document primarily states:
"Documentation was provided which demonstrated the Tension Band Anterior Spinal System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, anatomic sites, performance and material of manufacture."
§ 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.