Search Results

The LEUCADIA™ MIS Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

The Leucadia™ MIS Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Leucadia™ MIS Pedicle Screw System consists of a variety of rods and cannulated screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Multi-axial implant screws are supplied in 5mm, 6mm, and 7mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The ø1.7mm cannulation allows the screws to be implanted over a guidewire in a "mini open" or minimally invasive procedure. The Leucadia™ MIS Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent. The Leucadia™ MIS Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Leucadia™ MIS Pedicle Screw System implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, Leucadia™ MIS Pedicle Screw System components should not be reused.

The provided text describes a medical device, the LEUCADIA™ MIS Pedicle Screw System, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based device. The document is a 510(k) summary for a physical spinal implant system.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample size for a test set, data provenance, or details about training sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is focused on the mechanical and material equivalence of a physical medical device.

Ask a specific question about this device