(140 days)
DeRoyal Back Table Covers are intended to provide a sterile surface for a surgical operating room back table that becomes part of the sterile field. DeRoyal's Back Table Covers will provide protection against contamination during surgical procedures.
DeRoyal will receive the nonsterile back table covers from a converter made to DeRoyal's specifications. DeRoyal will use them to wrap convenience kits that will be sterilized in a header pouch. When the convenience kit is removed out of the header pouch it will be used as a surgical drape for the surgical operating room back table. DeRoyal will market nonsterile sterilization wrap to other OEM customers.
This document is a 510(k) clearance letter from the FDA for a surgical drape, not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, I cannot extract the requested information as it is not present in the provided text.
Specifically, the document discusses:
- The FDA's review and determination of substantial equivalence for the DeRoyal Surgical Drapes BackTable Cover to a legally marketed predicate device.
- Regulatory requirements and guidelines for marketing the device.
- The intended use of the device ("to provide a sterile surface for a surgical operating room back table that becomes part of the sterile field" and "provide protection against contamination during surgical procedures").
- Manufacturing and sterilization processes for the device.
There is no mention of acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment, expert qualifications, or details about comparative effectiveness studies for an AI/ML 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.