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The Modified Novy Cornual Cannulation Set is intended for use through the operating channel of a hysteroscope or other uterine access device, for hysteroscopic selective catheterization and cannulation of the proximal fallopian tube(s), followed by the introduction of chromotubation or contrast medium, in the evaluation of tubal patency.

The Modified Novy Cornual Cannulation Sets consist of an introducing catheter, an obturator, and an inner catheter with wire guide, a blue endoscopic septum cap, and two female Luer lock plugs. With this submission, Cook intends to offer two Novy Sets with curved introducing catheters. Introducing catheters are 5.0 French in size. The curved introducing catheters measuring 35 centimeters or 40 centimeters in length are manufactured with Nylon Torcon with a bonded Nonradiopaque tip. Both Novy Set are supplied sterile and intended for one-time use.

The provided text describes a medical device, the "Modified Novy Cornual Cannulation Set," and its substantial equivalence to a predicate device. However, it does not contain information about an AI/ML powered device, an acceptance criteria table with reported device performance metrics like sensitivity or specificity, or details about studies involving sample size, data provenance, expert ground truth, adjudication, or MRMC comparative effectiveness studies.

The document discusses various performance tests for the device, which are related to its physical and material properties, rather than diagnostic accuracy or AI performance. The provided information solely pertains to the mechanical and biological safety of the device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI-powered device, study details regarding human readers, or AI performance, as these are not present in the given text.

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