(45 days)
Presbyterian Linen Services Surgical Packs are intended to be used in various surgical procedures. The packs provide sterile gowns, drapes and towels to be used during procedures to protect both the surgical patient and the operating room personnel from transfer of microbial and other contamination. Surgical towels provide additional absorption of blood and body fluids when used to square off a surgical site, or may be used by operating room personnel for drying of hands after scrubbing.
Presbyterian Linen Services Surgical Packs are packs composed of reusable gowns, drapes, and toweling, the specifics of which are tailored to the customer's specifications for that procedure.
I'm sorry, but based on the provided document, I cannot generate the requested information about device acceptance criteria and a study proving those criteria.
Here's why:
- The document is a "Summary of Safety and Effectiveness" for a surgical procedure pack, which is a sterile medical device. It focuses on establishing substantial equivalence to previously cleared devices (K932522, K935199, K930700) based on material and construction similarities, rather than presenting a performance study with detailed acceptance criteria and results as typically found for diagnostic or interventional devices with quantitative performance metrics.
- The document describes reusable gowns, drapes, and toweling. These types of devices generally have different regulatory pathways and "performance" is often related to sterility, material integrity, and barrier properties, which are typically assessed through recognized standards and testing, not clinical studies with "test sets," "ground truth," or "expert readers" in the way described in your prompt.
- The request specifically asks for details relevant to diagnostic/AI-assisted devices, such as "reported device performance," "sample sizes," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "type of ground truth" for a study proving the device meets acceptance criteria. These concepts are not applicable to the type of device and regulatory submission presented in the input.
Therefore, the provided document does not contain the information necessary to fulfill your request.
§ 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.