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These devices are used to remove excess fluid and debris from the surgical area or instrument. Also, placed on the cornea to moisten the cornea and protect the retina from the intense operating light during ophthalmic surgery.

Hurricane Medical corneal light shields are manufactured from non-linting hydrophilic polyvinyl alcohol sponge with a pore size of approximately 100 micron.
Hurricane Medical wipes are made from medical grade nonlinting hydrophilic polyvinyl alcohol (PVA) sponge.
Hurricane Medical Eye Sponges and Spears are highly absorbent materials designed for absorption of fluids during eye surgery. Absorbent materials will include hydrocellulose, polyvinyl alcohol, viscose and US-origin cotton.
Hurricane Medical fluid wicks are made from non-linting polyvinyl alcohol (PVA) sponge with a pore size of approximately 100 microns.

The provided text focuses on the summary of safety and effectiveness for several medical devices (Corneal Light Shield, Instrument Wipes, Surgical Spears and Sponges, Fluid Wicks) and their FDA 510(k) clearance. It does not contain information on acceptance criteria for a device, nor does it describe a study proving the device meets specific acceptance criteria using the detailed points requested in your prompt.

Specifically, the document discusses:

• Historical context and problem statement: The need for corneal protection during ophthalmic surgery due to light-induced retinal damage.
• Device description: Materials and sterilization methods for the Hurricane Medical products.
• Predicate device comparison: The 510(k) clearance process implicitly relies on substantial equivalence to predicate devices, but the technical details of how current devices meet specific performance metrics are not described.
• FDA Clearance: The letter from the FDA confirms the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, or MRMC studies from the provided text. This document is a regulatory summary for device clearance, not a detailed study report.

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