(167 days)
The Vertiwedge® Intraosseous System is indicated for use in the thoracolumbar spine (TI-L5) for partial replacement of a diseased or damaged vertebral body resected or excised to replace a portion and/or restore the height of a collapsed vertebral body for the treatment of previous trauma (i.e. fracture or tumor) or degenerative spine disease. The system is to be placed within the vertebral body following an osteotomy and supplemented with autograft or allograft and to be used with its contralateral staple; should a physician choose to use fewer than the maximum number of screws, then supplemental fixation must be used to augment stability.
The Vertiwedge® Intraosseous System is intended to restore the integrity of the spinal column even in the absence of fusion in patients with advanced stage turnors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Vertiwedge® Intraosseous System is an intraosseous device that is used as a motion-preservation partial vertebral replacement device in the thoracolumbar spine in the motion-sparing Vertebral Body Osteotomy (VBO®) procedure. The Vertiwedge® Intraosseous device is used within a single osteotomized vertebral body, and it does not span any disc levels nor involve resection of or interference with the discs. The Vertiwedge® Intraosseous device is implanted through an anterior to psoas/oblique approach following an osteotomy of the vertebral body, in a Vertebral Body Osteotomy (VBO®) procedure The Vertiwedge® Intraosseous System consists of the intraosseous wedge (or spacer) with a lateral plate and a unique staple that provides integrated contralateral fixation. The Vertiwedge® Intraosseous System is available in a variety of heights and geometric options to accommodate variations in pathology and patient anatomy. Protrusions on the superior and inferior surfaces grip the osteotomized vedges to aid in expulsion resistance. The Vertiwedge® Intraosseous System is to be filled with autogenous bone graft and/or allogeneic bone graft material, and is to be used with the titanium alloy bone screws and cover plate to provide fixation within the single impacted vertebral body. All implant components are manufactured from Ti-6Al-4V ELI per ASTM F3001 or ASTM F136.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Vertiwedge® Intraosseous System." This document is primarily concerned with establishing substantial equivalence of a new medical device to existing predicate devices, rather than detailed performance data from a clinical or AI-based study.
Therefore, the information required to answer the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc., specifically related to AI device performance) is not present in the provided text. The "Performance Data" section solely lists mechanical and material testing standards (e.g., ASTM F2077, ASTM F1877, ASTM F2267) for the physical implant, which are relevant for demonstrating its structural integrity and safety as a physical medical device, not for an AI/software device.
To directly answer your request based on the provided text:
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A table of acceptance criteria and the reported device performance: This information is not explicitly stated in terms of an acceptance criterion table for an AI device. The document mentions "performance testing requirements" and that the subject device "met performance testing requirements," referring to mechanical and material tests. No specific numerical thresholds or performance metrics for an AI system are given.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "tests" mentioned are physical product tests, not data-driven studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as there is no data-driven study or ground truth establishment mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable, as there is no mention of a training set for an AI model.
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How the ground truth for the training set was established: Not applicable.
§ 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.