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PMT Facet Fixation System, Lumbar (PMT FFS-LX) is an integrated construct comprised of a CAVUX Cage and an ALLY Bone Screw. PMT FFS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct. PMT FFS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level (s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s). PMT FFS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.

PMT Facet Fixation System, Lumbar (PMT FFS-LX) is composed of CAVUX® Cages and ALLY® Bone Screws, an integrated construct, manufactured from medical grade titanium alloy and supplied sterile for single use only with a pre-attached disposable delivery handle/inserter. PMT FFS-LX provides temporary stabilization by spanning the facet interspace with points of fixation at each end of the construct and provides fixation as an adjunct to fusion. An ALLY Bone Screw is intended to be utilized to provide additional anchoring. CAVUX Cages are offered in a variety of sizes to accommodate various patient anatomies and pathology. The cage is designed to be filled with bone graft to permit formation of new bone through the device. ALLY Bone Screws are fully threaded. CORUS™ Spinal System is recommended to access the site and perform posterior fusion.

The provided text is a 510(k) Premarket Notification letter and summary for the PMT Facet Fixation System, Lumbar (PMT FFS-LX). This document details the device, its indications for use, comparison to predicate devices, and performance data.

However, the provided text DOES NOT describe an AI/machine learning medical device or its acceptance criteria and study findings. It refers to a physical medical device for spinal fusion (facet fixation system) and discusses mechanical and biomechanical testing, along with clinical and radiographic evaluations.

Therefore, I cannot extract the information required to answer your prompt, as it specifically asks for details related to:

• AI/Machine Learning device performance criteria.
• Sample sizes for test sets (in the context of AI models).
• Data provenance for AI models.
• Number and qualifications of experts for AI ground truth.
• Adjudication methods for AI ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
• Standalone AI performance.
• Ground truth types (pathology, outcomes data, typically for AI/imaging).
• Training set sample size and ground truth establishment for AI.

The document mentions "Clinical data were provided on the subject device, comparing to other lumbar fusion techniques, utilizing radiographic and CT evaluations, peri-operative findings, patient reported outcomes, and assessments of safety and effectiveness." and "Clinical and radiographic data provided satisfactory clinical outcomes to support use of the subject device". This refers to the clinical evidence for the physical device, not an AI algorithm.

In summary, the provided document does not contain the information requested in your prompt because the device in question is a physical surgical implant, not an AI/ML-based diagnostic or assistive software.

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