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The EBI CAS Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial vertebrectomy) of 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 CAS Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI CAS Spine Spacer 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 period of time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System, EBI Spinal System, or the EBI Array Spinal System.

The CAS Spine Spacer System is design modification of the EBI ESL Spine Spacer System. The EBI CAS Spine System is a vertebral body replacement device consisting of one curved implant. The pyramidal teeth on the superior and inferior ends resist expulsion in all directions. The device is available in flat or lordotic angles. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There are also holes through the anterior-posterior direction to allow for more bone growth through the device. The EBI CAS Spine Spacer System is intended for use with the EBI NGC Spinal System, the EBI Omega21™ Spinal System, EBI SpineLink™ II Spinal System, or the EBI Array Spinal System as a supplemental internal fixation system.

The provided 510(k) summary for the EBI CAS Spine Spacer System does not contain information about acceptance criteria or a detailed study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, intended use, materials, and function.

The key points from the document regarding performance are:

• Mechanical testing: "Mechanical testing comparing the EBI ESL Spine Spacer System to a predicate system demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements."

Without specific details on the "applicable standards and guidelines," the "functional requirements," or the results of the "mechanical testing," it's impossible to create the requested table of acceptance criteria and reported device performance.

Therefore, many of the requested sections (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, ground truth type, training set details) cannot be answered from the provided text.

Based on the available information, here is what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not specified. The document mentions "mechanical testing" but does not detail the number of units or any other sample size for this testing.
• Data provenance: Not specified, but given it's mechanical testing of a medical device, it would be laboratory-based testing rather than clinical data from a specific country or patient population. It is a retrospective comparison to a predicate device's performance.

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

• Not applicable as this was mechanical testing, not a study requiring expert readers to establish ground truth for image interpretation or clinical outcomes.

4. Adjudication method for the test set

• Not applicable as this was mechanical testing, not a study requiring adjudication of expert readings.

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

• No MRMC comparative effectiveness study was done. This 510(k) pertains to a physical medical implant (spinal spacer), not an AI-powered diagnostic or assistive technology.

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

• Not applicable, as this is a physical medical implant and not an algorithm or AI system.

7. The type of ground truth used

• For mechanical testing, the "ground truth" would be established by engineering specifications, material properties, and performance standards for spinal implants (e.g., strength, fatigue resistance, stability) as defined by regulatory bodies and relevant ASTM standards. These were presumably used in the "applicable standards and guidelines."

8. The sample size for the training set

• Not applicable, as this is a physical medical implant, not an AI system that requires a training set.

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

• Not applicable, as this is a physical medical implant.

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