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The PressON Spinal Fixation System is a posterior, non-cervical pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, lordosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The PressON Spinal Fixation System is composed of pedicle screws, cortical screws, couplers, and rods. These components can be assembled and implanted using associated instruments via a posterior approach into the pedicles of the noncervical vertebral bodies. Components are made from Ti-6Al-4V ELI (ASTM F136).

This document is a 510(k) premarket notification for the "PressON Spinal Fixation System." It is a regulatory document from the FDA, and as such, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document describes a spinal fixation system, which is a physical implant used in spinal surgery, not a software or AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, ground truth establishment, MRMC studies, or standalone performance, are not applicable to this submission.

The "Performance Testing" section explicitly states: "Mechanical testing was not performed as the additional parts for the PressON system did not create a new worst case scenario. All previously submitted testing for the PressON system (K223529) is applicable to the subject device." This indicates that the device's performance is established through mechanical testing (which is standard for spinal implants), but that testing was already performed and submitted under a previous 510(k) (K223529) for a very similar device.

Therefore, I cannot provide the requested information for an AI/ML device based on this document.

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