(156 days)
Ophthalmic sponge drains are used during surgery to protect delica tissue from trauma, absorb fluids, and to act as a filter to aspirate.
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I'm sorry, but this document does not contain the information requested. The document is an FDA 510(k) clearance letter for the Ultracell Suction Sponge, which is a medical device used in ophthalmic surgery. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the letter does not include any details about:
- Acceptance criteria or reported device performance for a study.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Types of ground truth used.
- How ground truth for a training set was established.
This document is a regulatory approval, not a technical report on a device's performance study.
§ 878.4450 Nonabsorbable gauze for internal use.
(a)
Identification. Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.