(116 days)
The SALUS® - Hygiene 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. The SALUS® - Hygiene is a reusable instrument reprocessing container intended to enclose and organize instruments that are designed to withstand steam sterilization and to maintain sterility of the reusable instruments during storage. The SALUS - Hygiene is suitable for use in dynamic air removal steam sterilizers.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "SALUS® - Hygiene Instrument Reprocessing Container." It outlines the FDA's determination of substantial equivalence for the device. Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/Machine Learning medical device.
Instead, this document pertains to a physical medical device (a sterilization container) and its performance is demonstrated through validation of sterilization cycles. The "acceptance criteria" here are inherent in the successful validation of these cycles (e.g., sterilization temperature, exposure time, drying time for specific sterilizer types and loads). The "study that proves the device meets the acceptance criteria" refers to the sterilization validation studies conducted by the manufacturer, the results of which are summarized in the table provided.
Therefore, I cannot extract the information required for an AI/ML device from this document. The questions you've posed (sample size for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are specific to the development and validation of AI/ML algorithms, not sterile processing containers.
If you can provide a document describing the regulatory submission and validation for an AI/ML medical device, I would be happy to help answer your questions.
§ 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).