(220 days)
Single Use Disposable OR Towel is typically used for draping, body fluid absorption, and hand drying in an OR application
Single Use Disposable OR Towel, Sterile and Non Sterile
I apologize, but this document is a 510(k) clearance letter from the FDA for a surgical towel (OR Towel, Sterile and Non Sterile). It confirms that the device is substantially equivalent to a legally marketed predicate device.
This type of document does not contain information about acceptance criteria or a study proving performance in the context of advanced AI/ML algorithms, clinical trials, or rigorous performance metrics typically associated with modern medical device approvals for complex diagnostic or treatment tools.
Therefore, I cannot extract the information you've requested regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, ground truth, or MRMC studies, as these concepts are not applicable to the content of this specific regulatory letter for a surgical drape accessory.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.