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The Aesculap PEEK Vertebral Body Replacement (VBR) System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture) to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aesculap PEEK VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap S4 System. The Aesculap PEEK VBR System implants can be used individually or in pairs. The Aesculap PEEK VBR System is also intended for use with bone graft.

The Aesculap PEEK VBR System is a vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. Components are offered in a variety of shapes and sizes to meet he requirements of the individual patient anatomy. Components are manufactured from PEEK – Optima (per ASTM F2026).

The Aesculap PEEK VBR System is a vertebral body replacement device. The provided text describes the performance data and the context of its 510(k) submission.

Here is the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Static and dynamic testing of the Aesculap VBR System was performed in accordance with ASTM F 2077 and/or F1717." These standards define the test methodologies (e.g., number of specimens, load cycles) for mechanical testing of spinal implants. However, the specific sample sizes (i.e., the exact number of devices tested for each condition) are not explicitly stated in the provided text.

Regarding data provenance, the testing was conducted on the Aesculap VBR System itself by Aesculap, Inc. This is essentially product testing rather than clinical study data involving patients, thus, "country of origin of the data" and "retrospective or prospective" do not apply in the typical sense. It is laboratory-based mechanical performance data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is a mechanical performance study, not a study evaluating expert judgment on medical images or clinical outcomes. Therefore, the concept of "experts used to establish ground truth" with specific qualifications (e.g., radiologist with 10 years of experience) is not applicable to this type of device and study. The "ground truth" here is the adherence to mechanical testing standards and material specifications.

4. Adjudication Method for the Test Set:

Not applicable, as this is a mechanical performance study based on established ASTM standards, not a clinical trial requiring adjudication of patient outcomes or image interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This submission pertains to the mechanical and material performance of a physical medical device (vertebral body replacement system), not an AI algorithm or a diagnostic tool that would typically involve multiple readers and cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. This is not an AI algorithm; it is a physical medical device.

7. The Type of Ground Truth Used:

The ground truth used in this context refers to established engineering standards and material specifications. Specifically:

• ASTM F2077 (Standard Test Methods for Static and Dynamic Testing of Intervertebral Body Fusion Devices)
• ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model)
• ASTM F2026 (Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

8. The Sample Size for the Training Set:

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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