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The FUSE Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (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; tumor; pseudoarthrosis; and failed previous fusion.

The FUSE Pedicle Screw System consists of longitudinal rods and polyaxial screws. It is manufactured from Ti-6Al-4V alloy conforming to ASTM F136.

This document is a 510(k) premarket notification for the FUSE Pedicle Screw System and does not contain information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The document states: "Performance data is not included in this submission. The design changes being included for review do not present a new worst-case configuration that would require additional performance testing." This indicates that the submission relies on the substantial equivalence to a predicate device (ACME Talon Pedicle Screw System, K071824) rather than new performance studies for the FUSE Pedicle Screw System itself.

Therefore, I cannot provide the requested information based on the provided text.

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