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The EBI AIS Spine System is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI AIS Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI AIS Spine System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time. The system must be used in conjunction with the EBI Omega 21 System or the EBI SpineLink System.

The EBI AIS Spine System is a vertebral body replacement device comprised of an anatomically shaped titanium implant. The EBI AIS is a single component device with a solid center core that provides structural integrity and slotted platforms that allows for bone growth around the center core. The superior and inferior platforms are flared outward to allow greater surface contact. The platforms are also designed with fins, which grip into the endplates of the vertebral body to reduce implant migration.

The provided text is a 510(k) summary for the EBI AIS System, a spinal fixation device. This type of document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (predicate device). It does not contain a detailed report of a study with acceptance criteria and device performance as typically expected for software or AI/ML devices.

The document states: "Mechanical testing comparing the AIS System to a predicate system demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements." This indicates that some form of testing was done to ensure equivalence to existing predicate devices, but the specifics of the acceptance criteria, study design, and results (like metrics, sample sizes, ground truth, etc.) are not provided in this summary.

Therefore, I cannot populate the table or answer most of your specific questions about acceptance criteria and study details because the information is not present in the provided text.

Here's what I can extract and what is missing:

Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not Available in the Provided Text):

• Sample sized used for the test set and the data provenance: Not mentioned.
• 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): Not applicable for mechanical testing of a physical implant.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.
• 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, as this is a physical implant, not an AI/ML diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, ground truth would be based on engineering specifications and physical measurements against established standards.
• The sample size for the training set: Not applicable, no training set for a mechanical device.
• How the ground truth for the training set was established: Not applicable.

What is mentioned:

• Study type: Mechanical testing.
• Comparison: The AIS System was compared to a "predicate system."
• Conclusion: The device complies with applicable standards and guidelines and meets all functional requirements.

This document serves to demonstrate substantial equivalence to existing devices through mechanical characteristics, not through clinical or AI/ML performance metrics.

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