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The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lenses are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or not-aphakic persons or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected using a chemical (not heat) disinfection system only.

The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens is a partially or totally white opaque lens that can be painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye condition. The lens may be totally opaque for a non-sighted eye or clear in the center for a sighted eye. The lens material (ocufilcon B) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate, methacrylic acid and cross-linked with ethylene glycol dimethacrylate, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The approved pigment, titanium dioxide, is incorporated into the monomer during polymerization with the help of a coupling agent. The titanium dioxide is evenly distributed throughout the lens and cannot be extracted. The lens is available in opaque patterns including Clear Lens with Opaque Pupil, Solid Opaque Lens, Solid Opaque with Clear Pupil, and Solid Annular Opaque with Clear Pupil & Clear Edge.

The provided text is a 510(k) summary for a medical device called "Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens." This type of submission to the FDA is for demonstrating substantial equivalence to a predicate device, not for proving the device meets acceptance criteria through a novel study.

The document does not contain any information about a study designed to prove the device meets specific acceptance criteria. Instead, it focuses on establishing substantial equivalence to previously approved devices based on materials, manufacturing, intended use, and physical properties. Therefore, I cannot construct a table of acceptance criteria and reported device performance from this document, nor can I provide information about sample sizes, ground truth establishment, expert adjudication, or MRMC studies.

Here's what I can infer from the document regarding the device and its characteristics, which in a different context might be parts of a performance specification:

• Intended Use/Indications for Use: The key "performance" aspect described is its intended use.
  • Daily wear to enhance or alter apparent eye color, including ocular masking.
  • For cosmetic management of conditions like corneal, iris, or lens abnormalities (sighted or non-sighted eyes).
  • For persons wishing to change the appearance of their eyes without abnormalities.
  • Correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic or not-aphakic persons.
  • Occlusive therapy for conditions such as diplopia, amblyopia, or extreme photophobia.
• Material: ocufilcon B (a hydrophilic copolymer).
• Physical Properties (these are listed as characteristics, not performance against criteria):
  • Refractive Index: 1.41
  • Light Transmission: varies depending on prosthetic design
  • Specific Gravity: 1.18
  • Water Content: 53%
  • Color Pigment Name: Titanium dioxide
  • Oxygen Permeability: $18.1 \times 10^{-11}$ @ 35°C (Revised Fatt Method)
• Disinfection Method: Chemical (not heat) disinfection system only.
• Prosthetic Design Options: Clear Lens with Opaque Pupil, Solid Opaque Lens, Solid Opaque with Clear Pupil, Solid Annular Opaque with Clear Pupil & Clear Edge.

Conclusion based on the provided document:

No specific study proving the device meets quantitative "acceptance criteria" is described. The document's purpose is to establish substantial equivalence to predicate devices, not to present a new clinical or performance study with defined acceptance criteria and statistical results. Therefore, most of the questions cannot be answered from the given text.

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