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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 Implex Hedrocel® Vertebral Body Replacement System, a medical device, and its 510(k) premarket notification. The information provided focuses on the regulatory submission and does not describe a clinical study in the typical sense (e.g., relating to AI device performance). Instead, it describes engineering performance tests to demonstrate substantial equivalence to previously approved predicate devices.

Here's the breakdown based on your request, adapted to the nature of the provided text:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are based on demonstrating "equivalent mechanical behavior" to predicate devices, as assessed by various tests. The "reported device performance" refers to the successful outcomes of these tests.

Study Details (Adapted for this type of device submission)

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

   • Test Set Sample Size: The document does not specify the exact number of physical device units tested for each mechanical test. However, it implicitly refers to a "test set" of devices that underwent the described mechanical and biocompatibility evaluations.
   • Data Provenance: The data was generated through laboratory testing of the Hedrocel® Vertebral Body Replacement System. This is a prospective generation of engineering test data for regulatory submission. The country of origin for the testing is not specified, but the submission is to the US FDA.

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

   • This is not applicable in the context of this device and its testing. "Ground truth" usually refers to clinical classifications or diagnoses. Here, the "truth" is established by adherence to engineering standards and by comparing the device's mechanical performance to established predicate devices under controlled laboratory conditions. The experts involved would be engineers and material scientists conducting and evaluating the tests, but no specific number or detailed qualifications are provided in this summary.

3. Adjudication method for the test set:

   • This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical image interpretation where there might be disagreement among human readers. For engineering performance tests, the results are typically quantitative measurements and comparisons against predefined standards or predicate device performance.

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:

   • No, a MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI-powered diagnostic or assistive tool.

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

   • No. This concept is not applicable as this is not an algorithm or AI device. The device's performance is standalone in the sense that its mechanical properties were tested directly.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this submission is established through objective engineering measurements and compliance with recognized industry standards, alongside comparison to the established mechanical performance characteristics of predicate devices. Biocompatibility data would also adhere to specific material science standards.

7. The sample size for the training set:

   • This concept is not applicable to this device submission. "Training set" refers to data used to train an AI algorithm. The Hedrocel® system is a mechanical implant and does not involve AI.

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

   • This concept is not applicable, as there is no training set for an AI algorithm.

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