(42 days)
Used during surgery to protect delicate tissue from trauma, absorb fluid and act as a filter to aspirate.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Ultracell Absorbent Stick." This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. It is a regulatory approval document confirming substantial equivalence to a predicate device, not a technical report detailing performance studies.
Therefore, I cannot provide the requested information based on the input text.
§ 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.