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TranS1® AxiaLIF® 2L System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2L System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L4-S1 interbody fusion.

The AxiaLIF® 2L System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2L System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.

The TranS1® AxiaLIF® 2L 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 tract to the LC-1.5-S 1 disc spaces. The track and the device's instruments are used for distracting the L4 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes implantable anterior fixation rods that are implanted through the same tract.

The provided text is a 510(k) Premarket Notification for the TranS1 AxiaLIF 2L System. This document describes a medical device (spinal intervertebral body fixation orthosis) and its intended use, but it does not contain information about acceptance criteria, study methodologies, or performance data comparing the device to these criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text. The document focuses on establishing substantial equivalence to a predicate device (TranS1 AxiaLIF II, K073643) rather than presenting detailed clinical or performance study results against specific acceptance criteria.

The FDA's letter states that they "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent." This determination is typically based on comparing the new device's technological characteristics, materials, and intended use to a legally marketed predicate device, often without requiring extensive new clinical studies that establish performance against explicit acceptance criteria in the way you've outlined.

**To answer your request, I would need a different type of document, such as a full clinical study report, a specific performance testing report, or a more detailed submission that includes: **

• Performance goals or acceptance criteria for the device.
• The methodology of a study designed to test these criteria.
• Results of that study.
• Details about sample sizes, ground truth establishment, expert qualifications, etc.

Based on the provided text, I can only extract these general facts:

• Device: TranS1 AxiaLIF 2L System
• Intended Use: Anterior stabilization of L4-S1 spinal segments as an adjunct to spinal fusion; minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L4-S1 interbody fusion.
• Indications for Use: Patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease.
• Predicate Device: TranS1 AxiaLIF II (K073643)

The document explicitly states: "The technological characteristics of the TranS1® AxiaLIF® 2L System have not changed," which is a key part of demonstrating substantial equivalence to the predicate device in a 510(k) submission. This usually implies that the performance is expected to be similar to the predicate, but it does not detail specific performance studies of the new device against new acceptance criteria.

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