Search Results

The VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.

The VBR Spinal 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.

The VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., KANEDA™ SR, UNIVERSITY PLATE™, M-2 ANTERIOR PLATE™, ISOLA®, VSP®, MOSS®MIAMI, TiMX™, MONARCH™, EXPEDIUM™, VIPER™, and PROFILE™).

The additional size cages are identical to the previously cleared stackable cages with regards to indications for use, function and material. The design of the cage is slightly different; the footprint of the device has been slightly modified.

The document provided is a 510(k) summary for a medical device called the "Bengal Stackable Cage System" (also referred to as "VBR Spinal System"). This is a premarket notification to the FDA for a medical device and not a study report for an AI/ML device. Therefore, the information requested in the prompt, which is specific to AI/ML device studies and acceptance criteria, is not present in the provided text.

The document discusses the device's intended use, materials, classification, and substantial equivalence to predicate devices, but it does not detail any AI/ML components, acceptance criteria for an algorithm, or a study proving an algorithm meets such criteria.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device