(24 days)
The surgical drape is used as a protective patient covering such as to isolate a side of surgical incision from microbial and other contamination.
Fanfold Drape (Surgical Drape) 41"x57"
The provided text is a letter from the FDA to Customed, Incorporated regarding their Fanfold Drape (Surgical Drape) - Product No. 900-633. This letter is a 510(k) clearance, indicating that the device has been found substantially equivalent to a predicate device and can be marketed.
However, the letter does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is solely a regulatory clearance document.
Therefore, I cannot provide the requested information based on the input text. The information requested (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is typically found in a detailed device validation report or a clinical study report, not in a 510(k) clearance letter.
§ 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.