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The TiWAVE-L™ Porous Titanium Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). TiWAVE-L Porous Titanium Lumbar Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The TiWAVE-L Porous Titanium Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device

The TiWAVE-L Porous Titanium Lumbar Cages are lumbar intervertebral body fusion devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile.

The provided text describes a medical device called the TiWAVE-L™ Porous Titanium Lumbar Cage, which is an intervertebral body fusion device. The document is an FDA 510(k) premarket notification summary.

Here's the analysis of the acceptance criteria and the study information based on the provided text, keeping in mind that this document describes a traditional medical device, not a software algorithm or AI model:

1. Table of Acceptance Criteria and Reported Device Performance

For traditional medical devices like the TiWAVE-L™ Porous Titanium Lumbar Cage, "acceptance criteria" and "device performance" are typically defined by engineering and biomechanical specifications rather than diagnostic performance metrics like sensitivity or specificity. The "study" here refers to non-clinical (mechanical and material) testing to demonstrate substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify exact sample sizes for the mechanical tests (e.g., number of cages tested for axial compression). It generally refers to "the TiWAVE-L Porous Titanium Lumbar Cage" being tested.
• Data Provenance: Not applicable in the context of this device. The data comes from non-clinical, in-vitro mechanical and material testing of the device itself, not from patient data, clinical trials, or retrospective/prospective studies on humans or animals.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. For mechanical and material testing of this nature, "ground truth" is established by adhering to recognized industry standards (e.g., ASTM standards) and performing the tests in a controlled laboratory environment. The "experts" would be the engineers and technicians conducting the tests and interpreting the results according to the specified standards.
• Qualifications: Not specified, but implied to be individuals competent in biomechanical testing and material science, following established protocols.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study requiring human interpretation or consensus. The results are quantitative measurements against predefined mechanical limits or comparison values from predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No MRMC study was done. The device in question is a physical implant, not a diagnostic or AI-assisted interpretation device. The document explicitly states: "No clinical studies were performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical medical implant, not an algorithm or AI.

7. The Type of Ground Truth Used

• Ground Truth: For this device, the "ground truth" is defined by established engineering and material science standards (e.g., ASTM standards) for intervertebral body fusion devices, and the performance characteristics of legally marketed predicate devices. The testing aims to demonstrate that the new device meets or exceeds these established benchmarks.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this device is not an AI/ML model or algorithm.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There is no training set or associated ground truth for this type of medical device submission.

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