(204 days)
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.
§ 886.4790 Ophthalmic sponge.
(a)
Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.