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TranS1 AxiaLIF Plus System is intended to provide anterior stabilization of the L5-S1 or L4-S1 spinal segment(s) as an adjunct to spinal fusion. The AxiaLIF Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion), spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 or L4-S1 in conjunction with legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF.

The TranS1 AxiaLIF Plus system is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 - S1 or L4-S1 disc space(s). The device's instruments are used for distracting the L5 – S1 or L4-S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.

This document is a 510(k) Premarket Notification from the FDA for a spinal fixation device, the TranS1 AxiaLIF Plus System. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria related to an AI or software-based medical device.

The provided text primarily discusses:

• The FDA's decision regarding substantial equivalence for the TranS1 AxiaLIF Plus System to a predicate device.
• Regulatory information about the device's classification, product code, and relevant regulations.
• The intended use/indications for use of the spinal fixation system.
• A summary of technological characteristics, stating it has the same characteristics as predicate devices.
• A brief mention of "engineering analysis and V&V performance testing" according to the predicate device, concluding that the results demonstrate substantial equivalence.

There is no mention of:

• Acceptance criteria in terms of metrics (e.g., sensitivity, specificity, accuracy) for a software or AI product.
• A specific study (e.g., clinical trial, reader study) demonstrating the device's performance against such criteria.
• Sample sizes for test or training sets.
• Data provenance, expert involvement, ground truth establishment, or any details about an MRMC study or standalone algorithm performance.

Therefore, I cannot provide the requested table or detailed information as the document pertains to a physical medical device (spinal intervertebral body fixation orthosis) cleared based on substantial equivalence to existing devices, and not a software/AI device that would typically undergo the type of performance validation implied by your detailed request.

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