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Adult patients with corneal opacity not suitable for standard penetrating keratoplasty with donor tissues, or where donor tissue has been declined, or where adjunctive measures required to prevent graft rejection are medically contraindicated.

The AlphaCor artificial cornea is made of flexible hydrogel PHEMA and comprises an optically clear core surrounded by a peripheral opaque sponge rim, which allows tissue ingrowth. The core allows transmission of light and provides refractive power, while the sponge skirt allows fibrovascular ingrowht for long term securing of the device into place. The AlphaCor device is implanted in a two stage surgical process using a modified intrastromal lamellar technique that places the posterior surface of the optic in direct communication with the anterior chamber. covers the anterior surface of the optic with the anterior corneal lamella and, usually, a conjunctival flap, and places the skirt within the lamellar pocket. The second stage of the surgical process consists of opening the anterior covering layers about 12 weeks post-implant, which exposes the anterior surface of the AlphaCor optic and allows light transmission into the eye. The AlphaCor is available in two different powers: AlphaCor-A™ for aphakic eyes and AlphaCor-P™ for phakic and pseudophakic eyes. AlphaCor-A™ delivers additional positive power to compensate for the absence of a lens in the aphakic eye.

The provided text is a 510(k) summary for the AlphaCor artificial cornea and the FDA's decision letter. It establishes substantial equivalence by comparing the device to a predicate device and outlines its intended use and description. However, it does not include a study that proves the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or any of the other detailed information requested in the prompt.

Therefore, I cannot extract the information to populate the table and answer the questions. The document pertains to regulatory approval based on substantial equivalence rather than a detailed performance study with quantifiable acceptance criteria.

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