Search Results

PMT Facet Fixation System (PMT FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. PMT FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. PMT FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. PMT FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.

The PMT Facet Fixation System (PMT FFS) is composed of CAVUX Cages and ALLY Bone Screws as an integrated construct with both manufactured from medical grade titanium alloy 6AI4V—ELI Ti (ASTM F136) and supplied sterile for single use only. The components are provided with a pre-attached disposable delivery handle/inserter. PMT FFS achieves facet fixation by spaming the interspace with points of fixation at each end of the construct and provides bilateral rigid fixation as an adjunct to fusion with ALLY Bone Screws providing additional anchoring.

CAVUX Cages are fusion devices offered in a variety of sizes to accommodate various patient anatomies and pathology. The center of the cage is hollow and designed to be filled with bone graft into the "windows" to permit formation of new bone through the cage. The ALLY Bone Screw is fully threaded. CORUS® Spinal System is recommended to access the site and perform posterior cervical fusion.

The document provided describes the PMT Facet Fixation System (PMT FFS) and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or detailed results of a study proving the device meets specific acceptance criteria.

The "Performance Data" section mentions that mechanical tests were performed and that clinical data from a prospective multicenter clinical study was presented, with long-term clinical and radiographic data providing "satisfactory clinical outcomes." However, specific quantitative acceptance criteria or the reported device performance against those criteria are not provided.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes, data provenance, ground truth establishment, expert involvement, or MRMC studies for this device. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than providing a detailed breakdown of performance studies and their acceptance criteria as might be found in a full study report or a PMA.

Ask a specific question about this device