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Ophthalmic sponge, used to absorb fluids from the surgical area during ophthalmic procedures, not intended to contact the cornea.

The Ophthalmic Solutions, LLC, The Fremstad Ring™ is used as a sponge. The device material consists of cellulosic and synthetic fibers. 14mm diameter, round, inner diameter 11mm, thickness 0.1 mm.

This 510(k) summary describes a new medical device, The Fremstad Ring™, an ophthalmic sponge, and its substantial equivalence to predicate devices. It focuses on sterility and biocompatibility testing. The document does not describe an AI medical device or a study involving human readers or AI algorithms. Therefore, I am unable to provide the requested information about acceptance criteria and an AI study, as those elements are not present in the provided text.

Specifically, the document contains:

• A general description of The Fremstad Ring™ and its intended use.
• A comparison table for substantial equivalence based on material and sterility with predicate devices.
• Details on sterility validation (ETO sterilization, SAL of 10^-6).
• Biocompatibility studies (cytotoxicity, ocular irritation, sensitization) and their conclusions.
• A letter from the FDA confirming substantial equivalence for the device.

Since the provided text does not relate to an AI device or a study assessing its performance against acceptance criteria, I cannot fulfill the request for information regarding AI performance metrics, sample sizes for test/training sets, expert qualifications, or MRMC studies.

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