(81 days)
INTENDED BE USED P COUERIN ﺮ INCISIO A SITE SURGICAL From AND other MICROBIAN CONTAMINATION
Not Found
The provided text is a 510(k) premarket notification approval letter for "Sterile Operating Room Towels, Blue" (K981823) from the FDA to Baldur Systems Corporation. This document is a regulatory approval and does not contain information about acceptance criteria or a study proving device performance as it pertains to AI/ML or diagnostic devices.
The information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are characteristic of the data typically provided in submissions for AI/ML-powered medical devices or diagnostic devices that require performance evaluation studies.
Since the device in question is "Sterile Operating Room Towels," a low-risk product, the FDA approval is based on substantial equivalence to a predicate device rather than on detailed performance metrics from a clinical study as would be required for more complex devices or AI/ML technologies.
Therefore, I cannot provide the requested information based on the input document. The document simply states the intended use as: "XXE INTENDED BE USED P COUERIN ﺮ INCISIO A SITE SURGICAL From AND other MICROBIAN CONTAMINATION" (intended to be used for covering an incision site during surgery from microbial contamination).
§ 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.