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The Continental 45 Toric (hefilcon A) Soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or nonaphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.

Continental 45 Toric (hefilcon A) Soft (hydrophilic) contact lens

This document is a marketing authorization for a contact lens and does not contain information about acceptance criteria or a study proving that a device meets such criteria. It primarily focuses on the regulatory approval process for the Continental 45 Toric (hefilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and reported device performance.
• Sample size used, data provenance, number of experts, qualifications of experts, or adjudication method for a test set.
• Information about MRMC studies, standalone performance, or the ground truth used for such studies.
• Sample size for a training set or how ground truth for a training set was established.

The document is a regulatory approval letter and an "Indications For Use" statement. It does not detail the technical performance or validation studies of the contact lens.

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