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The Medtronic Spinal and Biologics PYRAMID® +4 ANTERIOR LUMBAR PLATE Fixation System is indicated for use as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior lateral above the bifurcation (L1-L5) of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5)Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.

The subject device represents an expansion of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System. This system consists of a series of 3-hole and 4-hole plates as well as bone screws in a variety of sizes. The 3-hole plates are intended for use as an anterior fixation device while the 4-hole plates are intended for use as an anterior lateral fixation device. The system incorporates a locking mechanism to prevent the bone screws from backing out by covering the bone screw heads. Like its predicate counterpart, the subject device is intended for use as an anterior fixation device to supplement an anterior lumbar interbody fusion. The variety of the PYRAMID® +4 ANTERIOR LUMBAR PLATE System provides surgeons with options in the placement of the device to avoid interference with the vasculature, while still allowing for fixation. The PYRAMID® +4 ANTERIOR LUMBAR PLATE components are made of titanium alloy.

The provided text does not contain information about acceptance criteria for device performance, nor details of a study proving the device meets such criteria. This document is a 510(k) summary for a medical device (PYRAMID® +4 Anterior Lumbar Plate System), which primarily focuses on demonstrating substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested table or answer the specific questions about standalone studies, MRMC studies, sample sizes, ground truth establishment, or expert qualifications, as this information is not present in the provided text.

The closest relevant information, regarding how the device ensures its intended function and meets a standard, is mentioned under "V. Substantial Equivalence," which states: "Documentation, including mechanical test results, provided has demonstrated that the PYRAMID® +4 Anterior Lumbar Plate System is substantially equivalent to similar previously cleared devices..." However, it does not elaborate on what these mechanical tests entailed, what the acceptance criteria were, or the specific performance metrics.

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