(136 days)
This device is composed of 100% natural cotton fiber. The intended uses of an operating room towel are the absorption of fluids, including blood and body fluids while being used as patient drape at the incision site, or serving as a general use sterile towel for drying hands. The product is intended for single use and is disposable. This product is not intended to be used as a protective barrier.
This device is composed of 100% natural cotton fiber.
This document is a 510(k) premarket notification letter from the FDA to Broadline Medical Industries, Incorporated, regarding their "Broadline O.R. Towels." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
Crucially, this document does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device that uses an algorithm or AI functionality.
The "Broadline O.R. Towels" are described as being made of 100% natural cotton fiber and intended for absorption of fluids during surgery (blood, body fluids as a patient drape at the incision site, or a general use sterile towel for drying hands). They are for single use and disposable. The document explicitly states: "This product is not intended to be used as a protective barrier."
Therefore, I cannot answer your specific questions related to acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth for an AI/algorithm-based device, as this product does not appear to be such a device.
§ 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.