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The SEMIALTM Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The SEMIALTM is intended to be implanted singularly. The supplemental internal fixation systems that may be used with the SEMIALTM Spinal Implant are the same as the Curved PEEK Tetris Spinal Implant and include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).

The SEMIALTM Spinal implant is a hollow, semi-cylindrical form, slightly curved frame with tapered edges. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. The frame is forged from PEEK (PEEK-OPTIMATM LT1), which is radiolucent, and incorporates small Titanium alloy (TiAl6V4) marker pins so the device can be located within the body. The marker pins meet ASTM F-136 and ISO 5832/3. The SEMIALTM Spinal Implant is available in a variety of sizes ranging in height from 9 mm to 49 mm with a enrolling diameter of either 43mm or 38mm and either a 2.5° or a 5.2° angle. A list of SEMIALTM sizes and model numbers maybe found in Appendix A. The provision of varying heights, together with a wedge shaped option, to allow better lordosis control, enables the surgeon to choose the size suited to the individual pathology and anatomical condition. The SEMIALTM may be implanted individually.

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the SEMIALTM Spinal Implant, which primarily focuses on establishing "substantial equivalence" to a predicate device.

Therefore, I cannot provide the requested information. The document details:

• Device Description: A hollow, semi-cylindrical, slightly curved frame with tapered edges, made of PEEK with Titanium alloy marker pins.
• Intended Use: To replace a vertebral body resected due to tumor or trauma/fracture in the thoracolumbar spine (T1 to L5), intended for single implantation with supplemental internal fixation.
• Technological Comparison: States similarities to the predicate device (Curved PEEK Tetris™) in terms of indication for use, operating principle, basic design, materials, surgical techniques, supplemental fixation systems, manufacturing, sterilization, and packaging.
• Conclusion: The device is substantially equivalent to the predicate device based on these similarities.

This type of submission focuses on comparing the new device to an already legally marketed device (predicate) to demonstrate that it is as safe and effective, rather than presenting de novo clinical study data with specific acceptance criteria and detailed performance metrics.

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