(114 days)
The Dukal 20-001 - Fenestrated Dukal Surgical Drape, Blue, 18" x 26", with 3" Fenestration, and 20-002 - Dukal Surgical Drape, Blue, 18" x 26" 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 Dukal 20-001 - Fenestrated Dukal Surgical Drape, Blue, 18" x 26", with 3" Fenestration, and 20-002 - Dukal Surgical Drape, Blue, 18" x 26" 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.
I am sorry, but since this document is a letter from the FDA regarding the 510(k) premarket notification for a surgical drape, it does not contain the information requested in your prompt. Your prompt asks for details about the acceptance criteria and a study proving a device meets these criteria, typically associated with the performance of AI/Machine Learning medical devices.
This document is a regulatory approval letter for a physical product (a surgical drape), and therefore, the concepts of "test set," "ground truth," "MRMC study," "human readers," or "training set" are not applicable.
Could you please provide a document that describes the performance study of a device, likely an AI/ML-based medical device, if you would like me to answer those specific questions?
§ 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.