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The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is indicated for use for the management of irregular astigmatism, corneal degeneration or dystrophy caused by keratoconus, keratoglobus, pellucid marginal degeneration (PMD), post corneal trauma/scaring, post keratoplasty, post K-Pro, post RK, post LASIK, Salzmann's nodular degeneration. Cogan's dystrophy, granular corneal dystrophy, lattice corneal dystrophy or Reis-Bucklers dystrophy.

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is also indicated for therapeutic management of ocular surface disease from dry eye including ocular pemphigoid, Stevens-Johnson syndrome, symblepharon formation, graft vs host disease, persistent epithelial defect, exposure keratitis, neurotrophic keratopathy( herpes zoster, familial dysautonomia), Sjogern's syndrome, filamentary keratitis, limbal stem cell deficiency, atopy, ectodermal dysplasia. When prescribed for therapeutic use for irregular astigmatism or ocular surface diseases, the Ampleye Scleral RGP Lens may also provide correction of refractive error including myopia, presbyopia and regular astigmatism.

Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Ampleye Scleral RGP Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, or paflufocon D.

The provided document is a 510(k) summary for a contact lens device, the Ampleye Scleral RGP Lens. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical study with acceptance criteria in the way a novel therapeutic or diagnostic device would.

Therefore, the information typically requested in your prompt regarding acceptance criteria and detailed study results for device performance (e.g., accuracy, sensitivity, specificity, statistical significance with effect size) is not present for this contact lens device in this particular document.

Here's how to interpret the document in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria for a "device performance" study (e.g., accuracy metrics) are provided.
• Instead, the "performance" demonstrated is the ability to manufacture lenses to established finished product specifications within ANSI Z80.20-2016 tolerance and bioburden levels within acceptance criteria. These are manufacturing and safety standards, not clinical performance metrics in the sense of predictive or diagnostic accuracy.

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