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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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TranSl AxiaLIF® Plus System is intended to provide anterior stabilization of the L5-S1 or 14-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 LS-SI or L4-SI in conjunction with use of legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF:

The TranS1® AxiaLJF® 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 independently distracting the L5 - S1 or L4-S1 vertebral bodies and inserting bone grafi material (DBM, autograft or autologous blood) into the disc space. The device includes an anterior fixation rod that is implanted through the same approach and is used to lock the construct together.

This document describes the Premarket Notification (510(k)) Summary for the TranS1® AxiaLIF Plus system, which is a medical device for spinal fusion. The study described focuses on demonstrating substantial equivalence to predicate devices through mechanical, biomechanical, and system testing. This is not a study assessing the clinical performance or diagnostic accuracy of an AI/ML device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission.

Acceptance Criteria and Device Performance (Mechanical/Biomechanical Testing)

Study Details:

1. Sample size used for the test set and the data provenance: Not applicable. This study involved mechanical and biomechanical testing of physical implants, not a test set of patient data. The "test set" in this context refers to the physical devices and testing conditions.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM 1717) and pre-defined test protocols, not by expert consensus in the typical sense of clinical or diagnostic studies.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication is not relevant for mechanical and biomechanical testing. The results are quantitative and compared against established engineering thresholds.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not a clinical study involving human readers or AI.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a study of an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this study was established by engineering standards (ASTM 1717) and specific test protocols that define acceptable performance limits for spinal implant devices under various mechanical stresses (Static Compression Bending, Static Torsion, and Fatigue Compression Bending).
7. The sample size for the training set: Not applicable. There is no training set for mechanical and biomechanical testing.
8. How the ground truth for the training set was established: Not applicable.

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