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Sterile gel for human use, e.g. in medical procedures - to aid the introduction of catheters and endoscopic instruments in transurethral examinations, and in intermittent catheterization - particularly for incontinence treatment.

Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano® Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano® Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.

The provided text is a 510(k) summary for the Lubricano® Sterile Gel. It describes the device, its intended use, and states its substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, or performance data that would allow me to populate the requested table and answer the specific questions about device performance against acceptance criteria.

The document is a regulatory submission for a medical device (a sterile lubricating gel), which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies with predefined acceptance criteria and statistical analysis as would be required for a novel or high-risk device.

Therefore, I cannot provide the requested information from the given text. The provided document focuses on:

• Description: Composition and properties of the gel.
• Intended Use: As a lubricant for transurethral procedures.
• Substantial Equivalence Argument: Stating similarity in intended use and technological characteristics to a predicate device.
• Safety Profile: Mentioning results of in vivo and in vitro testing establishing safety (non-toxic, non-irritating, non-sensitizing) compared to the predicate.

None of these points include quantitative acceptance criteria, clinical study designs with sample sizes, expert ground truth establishment, or comparative effectiveness studies (MRMC) with human readers.

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