(30 days)
The TRUSS™ Thoracolumbar Plate System is intended for use in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or failed previous spine surgery.
The TRUSS™ Thoracolumbar Plate System consists of rigid and compression plates of various lengths that are used with variable or fixed angle bone screws. These plates attach to the anterolateral or lateral portion of the vertebral bodies of the thoracolumbar spine (T1-L5). Implants are composed of titanium allov, as specified in ASTM F136. F1295 and F1472.
The provided text describes a 510(k) summary for the TRUSS™ Thoracolumbar Plate System. It focuses on establishing substantial equivalence to predicate devices through mechanical testing. The document highlights the device's indications for use and its regulatory classification.
However, the provided text does not contain any information regarding clinical studies, acceptance criteria for device performance in a clinical context, or details about the methodological aspects requested such as sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for AI/device performance evaluation.
The "Basis of Substantial Equivalence" section explicitly states: "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." This indicates that the evaluation for this device was primarily based on benchtop mechanical testing to demonstrate performance similar to predicate devices, rather than a clinical study evaluating its performance against specific clinical acceptance criteria.
Therefore, I cannot provide the requested information in the format of the table and detailed points, as the input document does not contain this type of data.
To provide the requested details, a document describing a clinical study or performance evaluation with specific acceptance criteria, test sets, expert reviews, and ground truth methodologies would be necessary.
§ 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.