(247 days)
The Gemini Single Ply and Bonded Sterilization Wraps are intended to allow sterilization of the enclosed medical devices(s) and also maintain sterility of the enclosed medical device(s) within the period of time for which performance data demonstrating maintenance of sterility has been provided.
The Gemini Single Ply and Bonded Sterilization Wraps have been validated for use with Lumen, Non Lumen, and Flexible Cycles by the STERIS Amsco® V-PRO™ 1, Amsco® V-PRO™ 1 Plus, and Amsco® V-PRO™ maX Low Temperature Sterilization Systems.
Gemini Sterilization Wraps are offered to the market place as bulk packages of single and two ply bonded sheets of wrap for use by customers in accordance with standard hospital practices which require that two sheets are used each time a medical device or collections of medical devices are wrapped. The bonded wrap is comprised of two sheets of the Gemini Sterilization Wrap ultrasonically seamed on two parallel sides. This allows for convenient wrapping with two sheets simultaneously. The wrap allows for aseptic opening of the sterilized package.
Gemini Sterilization Wrap items are square or rectangular sheets of fabric produced using a five-layer SSMMS (spunbond-spunbond-meltblown-meltblown-spunbond) process.
The standard blue wrap fabric is made of polypropylene with the addition of less than 2% of phthalocyanine blue pigmentation and less than 0.35% titanium dioxide white pigmentation. The wraps are offered in 5 different shades of blue that vary in the amount of phthalocyanine blue pigmentation depending on the weight of the wrap. The lightest weight wrap has the least amount of blue pigment and the super heavy weight has the highest amount. Also, some wraps contain titanium dioxide and others do not.
Gemini Sterilization Wrap is available in sizes ranging from 12"x12" to 54"x72" across five different material weights/models.
This document describes the premarket notification (510(k)) for the Medline Gemini Sterilization Wrap. However, the provided text does not contain information about a study that assesses a device's performance against detailed acceptance criteria for an AI/CADe device, nor does it involve human readers improving with AI assistance, ground truth establishment by experts, or training/test sets as would be typical for such a device.
The document is for a medical device (sterilization wrap) which is evaluated based on its ability to maintain sterility and its physical properties. The testing described is primarily bench testing and biocompatibility testing, not clinical performance or AI algorithm validation.
Therefore, I cannot fulfill your request using the provided input, as the information required for an AI/CADe device's acceptance criteria and study proving its performance against those criteria is simply not present in this regulatory submission for a sterilization wrap.
To provide a descriptive answer, the input must be a regulatory document for an AI/CADe device, or a device that involves image analysis, diagnosis, or has a human-in-the-loop component with AI assistance.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).