(46 days)
The Sustain Radiolucent Spacer is a vertebral body replacement device 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 Sustain Radiolucent Spacer is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material.
The Sustain Radiolucent Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Sustain Radiolucent Spacer is a vertebral body replacement device used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside of the spacer. Protrusions on the superior and inferior surfaces of each device will grip the endplates of the adjacent vertebrae to resist expulsion.
The Sustain Radiolucent Spacer devices are made from radiolucent polymer and titanium alloy as specified in ASTM F2026 and F136.
The provided 510(k) summary for the Globus Medical Inc. Sustain Radiolucent Spacer details a medical device, not a software algorithm or AI-powered system, therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML is not applicable.
The document indicates that the device's substantial equivalence is based on its similarity to a predicate device (Globus Sustain Spacer K031302) and highlights mechanical testing according to "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000. This implies that the 'acceptance criteria' were met through established biomechanical benchmarks for spinal implants, rather than performance metrics related to diagnostic accuracy, sensitivity, or specificity that would be relevant for AI studies.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these pertain to the evaluation of AI/ML models.
§ 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.