(102 days)
The Expedium™ Anterior Spine System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The Expedium Anterior Spine System may be used in either thoracoscopic procedures or open procedures.
The Expedium Anterior Spine System is indicated for:
- degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- spondylolisthesis
- trauma (i.e., fracture or dislocation)
- spinal stenosis
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- tumor
- pseudarthrosis
- previous failed fusion
The Expedium Anterior Spine System consists of spinal rods, monoaxial screws, staples, washers, and cross connectors. The implants of the Expedium Anterior Spine System have been designed for use in either open or thoracoscopic approaches. Manufactured from ASTM F-136 implant grade titanium alloy.
The provided text is a 510(k) summary for the Expedium™ Anterior Spine System, a medical device. It does not include information about acceptance criteria, device performance metrics, or study design details that would typically be found in a performance study report.
Specifically, the "Performance Data" section in the 510(k) summary (page 1, section PERFORMANCE DATA) simply states: "Performance data were submitted to characterize the [device]." It does not elaborate on what that data entails, the criteria used to evaluate it, or the results.
Therefore, none of the requested information (acceptance criteria, reported device performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, type of ground truth, training set sample size, or ground truth establishment for training set) can be extracted from the provided document.
This document is a regulatory submission summary, primarily focused on describing the device, its intended use, and establishing substantial equivalence to a predicate device, rather than detailing the results of performance studies.
§ 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.