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The Cayman Buttress Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The Cayman Buttress Plate System are non-load bearing devices, each consisting of a screw and plate of various sizes and screw for attachment to the vertebral body in the anterior lumbar spine. Materials: The devices are manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards. Function: The plates are designed to be used in spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.

The provided text is a 510(k) summary for the Cayman Buttress Plate System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full study to meet specific performance acceptance criteria. Therefore, the document does not contain the information requested regarding specific acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC comparative effectiveness studies.

The summary states: "The Cayman Buttress Plate System is considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use and are expected to be equivalent in safety and effectiveness."

This means the "acceptance criteria" for this submission are based on demonstrating similarity to already approved devices, rather than meeting quantitative performance metrics through a clinical or rigorous standalone study.

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