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The Quantum Vertebral Body Replacement is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

The Quantum Vertebral Body Replacement is a generally box-shaped device with various holes located throughout its geometry. The exterior surface of the device has teeth to help keep the device from migrating once placed in its desired location. It is available in a multitude of sizes to suit the individual pathology and anatomic condition of the patient. The device may be made from titanium or polyetheretherketone (PEEK).

The provided text is a 510(k) Summary for a medical device called the "Quantum Vertebral Body Replacement." It describes the device, its intended use, and states that "Mechanical testing indicates that the Quantum Vertebral Body Replacement is capable of performing in accordance with its intended use."

However, this document does not contain any information regarding specific acceptance criteria, detailed study designs (including sample sizes, data provenance, expert qualifications, or adjudication methods), or performance metrics beyond a general statement about mechanical testing.

Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data elements are not present in the provided text.

Based on the provided input, the following information is unavailable:

• A table of acceptance criteria and the reported device performance: No specific acceptance criteria or quantitative performance metrics are listed. The document only states that mechanical testing indicates the device is "capable of performing in accordance with its intended use."
• Sample sized used for the test set and the data provenance: No information on test set sample size or data provenance is provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device (a physical implant) would typically rely on mechanical testing rather than expert-established ground truth on images or clinical data in this context.
• Adjudication method for the test set: Not applicable.
• 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 medical implant, not an AI-assisted 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, as the evaluation type appears to be mechanical testing.
• The sample size for the training set: Not applicable, as this is a physical medical implant and not a machine learning model.
• How the ground truth for the training set was established: Not applicable.

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