(234 days)
The Wiltse System Is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Wiltse System is also intended for anterolateral screw fixation of the noncervical spine. Indications for this system include treatment of cases of spondylolisthesis, fracture, spinal stenosis, deformittes (including scollosis, kyphosis, and lordosis), tumor, pseudoarthrosis, and revision of failed previous fusion surgery. Other indications include degenerative lumbar scollosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required.
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The provided text is a 510(k) clearance letter from the FDA for the "Wiltse System." This document primarily focuses on regulatory approval and indications for use, not on detailed acceptance criteria or a study proving device performance against such criteria.
Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text.
The closest information provided is the "Indications For Use," which outlines the conditions and patient populations for which the device is intended. This is a regulatory statement about its intended application, not a performance metric.
§ 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.