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The TranS1® AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1@ AxiaLIFTM is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet and pedicle screw systems.

The TranS1® AxiaLIFTM 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 1.5 - S1 disc space. The track and the device's instruments are used for distracting the L5 - 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.

The information provided does not contain a specific study designed to prove the device meets acceptance criteria. Instead, it describes a 510(k) premarket notification for a medical device (TranS1® AxiaLIF™ System) where a modification to its indication statement is being sought.

Here's a breakdown based on the provided text, addressing your questions where possible:

Acceptance Criteria and Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format (e.g., a specific success rate, accuracy, sensitivity, or specificity). The core of this 510(k) is a claim of substantial equivalence to a previously cleared device. Therefore, the "acceptance criteria" for the modified indication is that the device, with its new indication, is considered as safe and effective as the predicate device.

The "device performance" is implicitly based on the substantial equivalence argument, which hinges on the fact that:

• Technological Characteristics: "The technological characteristics of the TranS1® AxiaLIFTM System have not changed."
• Biomechanical/Clinical Testing: "A significant amount of biomechanical and clinical testing of facet screws, and of facet screws in comparison to pedicle screws, appearing in the literature and as performed by TranS1®, establish that facet screw fixation will provided adequate posterior stabilization when used with the anterior stabilization of the AxiaLIF™ 3D Axial Rod™ (which is part of the AxiaLIFTM System)."

Therefore, a table of acceptance criteria and reported device performance directly from this document is not possible as it would be for a typical performance study. The "performance" is that its use with facet screws is "adequate" for posterior stabilization, based on existing literature and testing.

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document refers to "biomechanical and clinical testing" but does not specify sample sizes, data provenance (e.g., country of origin), or whether it was retrospective or prospective for the specific data submitted to support the expanded indication. It mentions "appearing in the literature" which suggests published studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided. The application relies on existing literature and prior testing, not a new reader study to establish ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided, as a specific "test set" and a corresponding adjudication process are not described in the context of this 510(k) submission.

5. 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:

This type of study is not mentioned. The device is a surgical implant, not an AI-based diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This question is not applicable. The device is a surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the claim of "adequate posterior stabilization" appears to be based on:

• Biomechanical testing (likely cadaveric or in-vitro models to measure forces, stability, etc.).
• Clinical testing (likely outcomes data from studies involving facet screws, or comparative studies of facet vs. pedicle screws).
  The document does not detail specific methods for establishing this ground truth.

8. The sample size for the training set:

This concept (training set) does not apply here as the device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established:

This question is not applicable, as there is no training set mentioned for this medical device submission.

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