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VISINE FOR CONTACTS Rewetting Drops may be used with daily and extended wear soft (hydrophilic) contact lenses for the following:

• Moistening of daily wear soft lenses while on the eyes during the day
• Moistening of extended wear soft lenses upon awakening and as needed during the day
• Moistening of extended wear soft lenses prior to retiring at night
  Placing 1 or 2 drops of VISINE FOR CONTACTS Rewetting Drops on the eye followed by blinking 2 or 3 times will relieve minor irritation, discomfort and blurring which may occur while wearing lenses.

Visine for Contacts is specially formulated to use while wearing contact lenses to moisten lenses, soothe, refresh and moisturize dry, irritated eyes. Visine for Contacts is safe and effective for individuals with eyes sensitive to thimerosal. It moistens lenses and helps remove particulate matter that may cause irritation and/or discomfort.

The provided document is a 510(k) summary for a medical device called "Visine for Contacts Lubricating/rewetting eye drops." It describes the product, its intended use, and indicates that it is "substantially equivalent" to already marketed devices.

However, the document does not contain any information about acceptance criteria, detailed study designs, sample sizes for test/training sets, or expert involvement for establishing ground truth as typically found in studies for AI/algorithm-based devices. This 510(k) pertains to a chemical product (eye drops) and its safety and efficacy are demonstrated through comparison to existing, legally marketed chemical products, not through the performance of an algorithm.

Therefore, I cannot populate the requested table and answer the questions related to AI/algorithm performance. The information needed for those sections is simply not present in the provided text.

The document states:

• "Studies showed no clinically or statistically significant differences between Visine For Contacts and currently marketed products for any parameters. Therefore, Visine for Contacts is as safe as the marketed products when used as directed." This indicates that comparative safety and possibly efficacy studies were performed, but details about their design, acceptance criteria, methods for establishing ground truth, or sample sizes are not provided, nor are they relevant to an AI-based device.
• The comparison is based on "Technological Characteristics" (i.e., ingredients) and "Safety" against predicate devices like "Clear Eyes CLR" and "Lens Express."

In summary, as your request is framed around acceptance criteria and studies for an AI-based device, and the provided document is for a chemical product (eye drops), I cannot fulfill the request in the way it's structured.

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