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The Interpore Cross International AFD is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Interpore Cross International AFD is also indicated for treating fractures of the thoracic and lumbar spine. The Interpore Cross International AFD is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The Interpore Cross International AFD is a titanium alloy spacer for vertebral body replacement. It has a predominately hollow center and outer ring with screws for fixation into the vertebral bodies. The hollow center allows for the addition of bone graft material. In addition, there are ridges on the superior and inferior surfaces of the implant to enhance placement and prevent expulsion.

The provided text describes a 510(k) summary for the Interpore Cross International Anterior Fixation Device (AFD). This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing.

Here's an analysis of the acceptance criteria and study information based on the provided text, addressing your specific points:

Acceptance Criteria and Device Performance

Missing Information: The specific numerical targets for each mechanical test (e.g., minimum compression strength in Newtons) and the actual numerical results achieved by the AFD are not detailed in this summary. The summary only gives a qualitative statement that the device "meets or exceeds all functional requirements."

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified for the mechanical testing. "Data regarding the functional performance... has been generated" implies a test set was used, but the quantity of devices tested for each mechanical assessment is not mentioned.
   • Data Provenance: The study is non-clinical mechanical testing, performed by Interpore Cross International. No information is given regarding country of origin of data or whether it's retrospective/prospective, as these terms are typically applied to human clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This was a non-clinical mechanical engineering study, not involving human experts for ground truth establishment in the way clinical studies do. The "ground truth" is defined by established engineering and biomechanical standards for spinal implants.

3. Adjudication method for the test set:

   • Not applicable. This was mechanical testing, not requiring adjudication by human experts.

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 a medical device for vertebral body replacement, not an AI-assisted diagnostic or imaging device that would involve human readers.

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

   • Standalone mechanical testing was done (the device itself was tested). However, "standalone" in this context typically refers to an algorithm's performance without human interaction, which is not relevant for this physical implant.

6. The type of ground truth used:

   • The ground truth for the mechanical testing was based on "all functional requirements," which are derived from established engineering standards and biomechanical principles for spinal implants. These would typically include industry standards and possibly internal company specifications for static axial compression, torsional loading, shear compression, and expulsion.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an algorithm that requires a "training set" in the machine learning sense. The design and manufacturing process would involve iterative testing and refinement, but this isn't a "training set" like in AI.

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

   • Not applicable for the same reason as point 7. The "ground truth" for the performance specifications of the device would be based on biomechanical considerations and regulatory requirements, influencing the device's design and engineering.

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