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The Blackstone Medical Surgical Titanium Mesh System is indicated for use in the thoraco-lumbar spine (T1-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 Surgical Titanium mesh is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh 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. It is recommended to pack bone graft material inside the mesh cage prior to implantation.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the Surgical Titanium Mesh System is the Blackstone Medical Spinal Fixation System.

The Blackstone Medical, Inc. Surgical Titanium Mesh System is comprised of a hollow cylindrical tube made from commercially pure (CP) titanium conforming to ASTM F-67. The walls of the tube are perforated with evenly spaced diamond-shaped openings. These openings and the hollow core allow grafting material to be placed inside the device to help achieve solid fusion. Because of the construction, the angle and the length of the mesh can be reduced incrementally to adjust it to individual anatomical conditions. The end rings, standard ring and screws of the device are made of titanium alloy (6AL-4V ELI, per ASTM F136). The end rings, which are placed onto each end of the tube, feature spikes on the exterior sides that help prevent lateral movement of the device.

The provided text is a 510(k) summary for a medical device (Blackstone™ Surgical Titanium Mesh System Angled End Rings) and does not contain information about acceptance criteria or a study proving device performance.

510(k) submissions, particularly for devices like spinal implants, typically demonstrate substantial equivalence to a predicate device rather than conducting new clinical trials or detailed performance studies using AI/software. The "Basis of Substantial Equivalence" section in the document explicitly states this: "The Blackstone™ Surgical Titanium Mesh System Angled End Rings are substantially equivalent to the Blackstone Surgical Titanium Mesh System (K030744), which has been cleared by FDA for use in patients with tumor, trauma or fractures."

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance through substantial equivalence, not on a specific performance study with acceptance criteria for an AI or software component.

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