(20 days)
The ASEP™ Plus Back Surgical Drapes are used to cover accessory tables in the operating room The fluid repellent properties of the drapes aid in the control of microbial and other contamination.
Medline ASEP™ Plus Reusable Surgical Drapes (Mayo Stand Cover and Back Table Cover)
The provided text is a 510(k) premarket notification approval letter for the Medline ASEP™ Plus Reusable Surgical Drapes. This document indicates the FDA's decision that the device is "substantially equivalent" to legally marketed predicate devices.
Crucially, this document is a regulatory approval letter and not a study report. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other technical details requested in your prompt. The FDA's substantial equivalence determination for this type of device (surgical drapes) typically relies on material characteristics and performance against established industry standards for barrier properties, durability, and biological safety, rather than a "study that proves the device meets the acceptance criteria" in the way one would analyze a diagnostic or AI-driven device.
Therefore, I cannot provide the requested information from the provided text. To answer your prompt, I would need a detailed study report or technical data sheet for the Medline ASEP™ Plus Reusable Surgical Drapes.
§ 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.