(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.
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Presbyterian Healthcare System
Presbyterian Hospital 200 Hawthorne Lane Post Office Box 33549 Charlotte, NC 28233-3549 (704) 384-4000 http://www.presbyterian.org
SUMMARY OF SAFETY AND EFFECTIVENESS
January 21, 1997
K970286
Regulatory Information 1.
Device Name: Surgical Procedure Packs Presbyterian Linen Surgical Procedure Packs Proprietary: Surgical Packs Common : Classification: Surgical Procedure Packs
Submitted on behalf of Presbyterian Linen by: 2.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060 (847) 949-2639 Phone: (847) 949-2643 Fax: Lara N. Simmons Contact Person: See Attached Letter of Authorization
Presbyterian Linen Services' Surgical Packs are substantially equivalent to the following:
- K932522 AMSCO Sterile Recoveries Surgical Packs 1.
- K935199 Associated Hospital Services, Inc. Surgical Packs 2.
- K930700 Medline's Repeat Performance Surgical Pack System 3.
Presbyterian Linen's Surgical Packs are virtually identical to the predicate devices listed above. The gowns, towels and drapes are of the same material and construction. There are no technological differences between the Presbyterian Linen packs and the predicate devices.
Device Description
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.
Intended Use:
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.
The Whole Approach To Health.
11
§ 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.