Search Results

The Wallace Trial Transfer Catheter is a sterile single-use device intended to assess advancement through the cervical canal and positioning of the uterus

The Wallace Trial Transfer Catheter is a single use, sterile, disposable, soft, and flexible catheter with a unique round smooth distal end. The tip has a blind/closed end. The device has an overall length of 23cm including a, polypropylene Luer Lock adapter that is affixed at its proximal end. The inner catheter is a clear tube with a 1.8-mm outer diameter and a 0.8 inner diameter that is uniform throughout its length. An outer sheath with a 2.3-mm outer diameter surrounds this inner catheter. The distal 0.1-cm of length gradually tapers, leaving the distal 5 cm of the inner catheter exposed. The proximal circumferences of the outer sheath and inner catheter are molded directly into the distal end of the Luer Lock adapter. Five black graduation markings are located on the distal portion of the outer sheath at 1- cm increments to indicate the degree of advancement into the cervix. Four black graduation markings are located on the proximal portion of the inner catheter at 1 cm increments indicate the degree of advancement into the uterus.

My apologies, but the provided text describes a medical device, the "Wallace Trial Transfer Catheter," and its 510(k) submission to the FDA. This submission focuses on establishing substantial equivalence to a predicate device based on technological characteristics and safety (biocompatibility, bacterial endotoxin, and ethylene oxide residuals).

The document does not describe the use of an AI device, nor does it contain any information related to acceptance criteria for an AI algorithm's performance, human reader studies, ground truth establishment methods, or sample sizes typically associated with AI model development and validation.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them in the context of an AI device. The information provided is for a physical medical catheter, not a software or AI-driven device.

Ask a specific question about this device