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The Nutrifill preservative free insertion solution is indicated as an insertion solution for large diameter (scleral), hybrid and rigid gas permeable (RGP) contact lenses following proper lens care disinfection as recommended by the eye care practitioner. This solution may also be used for rinsing debris and lens cleaners from rigid gas permeable, hybrid and hard contact lenses, as a rinse for contact lens cases and may be used as needed throughout the day to rinse contact lenses.

The Nutrifill preservative free insertion solution is a sterile isotonic buffered solution containing electrolytes (calcium, magnesium, phosphate, sodium) in a single dose, carry-on size 10ml vial. It rinses loose debris and cleaning solution off rigid gas permeable (RGP), hard and hybrid contact lenses prior to insertion. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.

The provided text describes a 510(k) summary for a contact lens insertion solution called Nutrifill. It outlines the device's characteristics and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of a medical imaging or AI device.

The "Performance Data" section explicitly states:

• Non-Clinical Studies: "A series of studies were completed to demonstrate the substantial equivalence of the Nutrifill preservative free insertion solution to the predicate device. Results of non-clinical testing demonstrate:
  • The Nutrifill solution is non-toxic and non-irritating
  • The final packaging is non-toxic and non-irritating"
• Clinical Studies: "Clinical studies involving the Nutrifill solution were unnecessary for this application. Lens care solutions used with this Nutrifill solution are already cleared for use as cleaning, rinsing, disinfection and storage solutions for contact lenses."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria, as this information is not present in the given document. The submission focuses on demonstrating substantial equivalence to predicate devices for a contact lens care product, rather than reporting performance against specific acceptance criteria for a diagnostic or AI-driven device.

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