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The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

The Hedrocel® Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated. The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine. The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine. The use of titanium or titanium alloy instrumentation is recommended.

This document describes the 510(k) summary for the Hedrocel® Vertebral Body Replacement System. However, this is a medical device submission, not a study of an AI-powered device. Therefore, many of the requested categories for AI device evaluation are not applicable. I will extract the relevant information regarding acceptance criteria and performance data as presented in the provided text.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

The provided 510(k) summary for the Hedrocel Vertebral Body Replacement System focuses on demonstrating substantial equivalence to predicate devices through mechanical and biocompatibility testing, rather than a clinical study with specific performance metrics like sensitivity, specificity, or accuracy for an AI product.

Study Details (as applicable to a medical device submission of this nature)

Since this is a submission for a spinal implant and not an AI-powered diagnostic/therapeutic device, many of the typical AI study parameters are not relevant or not detailed in this type of regulatory document.

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

   • Sample size: Not explicitly stated as a "test set" in the context of human subjects or data. The testing refers to mechanical and biocompatibility evaluations of the device itself.
   • Data provenance: Not applicable. The "data" refers to the results of engineering and material science tests.

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

   • Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert human interpretation.

3. Adjudication method for the test set:

   • Not applicable. No human adjudication is mentioned for mechanical testing.

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 not an AI device.

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

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

6. The type of ground truth used:

   • For biocompatibility: Biological assays and in-vitro/in-vivo studies conforming to established standards for medical device materials.
   • For mechanical performance: Engineering measurements (e.g., force, displacement, wear) using standardized test methods and equipment, compared against performance of predicate devices.

7. The sample size for the training set:

   • Not applicable for a physical device. There is no "training set" in the AI sense.

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

   • Not applicable.

Overall Conclusion from the document:

The Implex Hedrocel Vertebral Body Replacement System demonstrated sufficient mechanical performance and biocompatibility to be considered substantially equivalent to already legally marketed predicate devices (K010378, K021025, K021967). The device was tested per applicable standards, and the provided results indicated it performs as intended and is equivalent to the predicates.

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