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The MinFlex Washer-Disinfector is intended for washing and high-level disinfecting one or two submersible flexible endoscopes that do not contact normally sterile areas of the body and that feature either no internal channel (i.e., a probe) or one internal channel. The types of flexible endoscopes for which the MinFlex Washer-Disinfector is labeled include those that are used to examine, diagnose, and treat diseases of the pulmonary tract, urinary tract, uterine cavity, and ear, nose, and throat (ENT) cavities.

System 83 Plus MiniFlex Washer -- Disinfector

This document is a 510(k) clearance letter from the FDA for a medical device called the "System 83 Plus MiniFlex Washer-Disinfector." It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The provided text describes the FDA's decision to clear the device for marketing based on its substantial equivalence to a legally marketed predicate device. The information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, ground truth establishment) is typically found in a clinical study report or a risk management document for an AI/ML device, which this document is not.

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