(189 days)
Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad® 100NX Express Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. The Instru-Safe Instrument Protection System has no lumen claims for the Sterrad 100NX Express Cycle.
Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider.
The provided text is a 510(k) premarket notification for a medical device called the "Instru-Safe® Instrument Protection System." This document is a regulatory filing with the FDA and does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The device described, an "Instrument Protection System," is a sterilization tray used to organize and protect other medical devices during sterilization. It is a traditional medical device, not an AI/ML diagnostic or therapeutic system. Therefore, the questions related to AI/ML device performance metrics (such as effect size of human readers with AI assistance, standalone algorithm performance, training set details, or ground truth establishment for AI models) are not applicable to this document.
The document lists "Indications for Use" which specify how the device is intended to be used, but these are not "acceptance criteria" in the sense of performance metrics for an AI/ML algorithm. The table on page 4/6 provides technical specifications for different parts of the "Instru-Safe® Instrument Protection System" (e.g., maximum number of instruments, estimated weight), which are characteristics of the physical device rather than performance metrics of a diagnostic algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance as it pertains to an AI/ML medical device from the provided document.
§ 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).