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Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans, disinfects and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses. This product is for professional in-office use only.

Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses consists of two solutions, Progent A and Progent B, which are mixed together when used. They are packaged separately in natural low density polyethylene (USP classification :VI) ampoules, type "Bottle Pack", containing 5.5 ml of solution, (5 ml being usable). Each package consists of 7 pairs of ampoules. Progent A contains sodium hypochlorite and sodium carbonate; Progent B contains potassium bromide and sodium carbonate. Rigid Gas Permeable Contact Lenses are placed into the lens holder cap of the cleaning vial (SP Vial). Progent A, then Progent B are poured into the case receptacle, then the lenses are soaked in the Progent mixture for 30 minutes.

The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.

The document describes a 510(k) premarket notification for a contact lens cleaning solution (Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses). The claim of substantial equivalence for this device is based on it being the same formulation as a previously marketed predicate device (K002140), with only the indications and directions for use being modified. The applicant performed non-clinical stability, toxicology, and microbiology testing to support this claim.

Therefore, the requested information regarding acceptance criteria for an AI/ML device, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, type of ground truth, training set size, and training set ground truth establishment is not applicable to this submission. This is a traditional medical device submission for a chemical product, not an AI/ML device.

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