(209 days)
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)
| Acceptance Criteria (Set by ASTM 1717 and Test Protocol) | Reported Device Performance (TranS1® AxiaLIF Plus) |
|---|---|
| Conformity to ASTM 1717 standard for device type | Met or exceeded requirements of ASTM 1717 and established test protocol |
| Static Compression Bending requirements | Met or exceeded requirements |
| Static Torsion requirements | Met or exceeded requirements |
| Fatigue Compression Bending requirements | Met or exceeded requirements |
| No new safety or effectiveness concerns raised | No new safety or effectiveness questions were raised |
Study Details:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- The sample size for the training set: Not applicable. There is no training set for mechanical and biomechanical testing.
- How the ground truth for the training set was established: Not applicable.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.