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The InnTec, Inc. Intrauterine Insemination (IUI) Catheter is used for intrauterine insemination.

The InnTec IUI Catheter has been specifically designed for Intrauterine Inseminations. The over all Catheter length is 17.5cm, and tapers from 7 Fr. at the hub down to 5 Fr at the distal tip which is 5cm long. The tip is closed and smoothly rounded, eyelets are located at 180° from one another. Catheter internal volume is .07cc. Centimeter marks are printed at 6, 7, 8, 9, & 10cm from the tip, the ink is non-toxic and will not rub off.

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for an "IUI Catheter" by InnTec, Inc., focusing on demonstrating substantial equivalence to a predicate device. It discusses the device's description, intended use, technology, and substantial equivalence determination by the FDA.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, ground truth details, expert qualifications, adjudication methods, or information about MRMC or standalone studies. The document only states that the "intended use, technology, materials and manufacturing processes of the Inn Tec, Inc. IUI Catheter are the same as the predicate device. No new questions of safety or effectiveness are raised." This implies that the device is considered safe and effective based on its similarity to an already approved device, rather than through specific performance metrics or a detailed clinical study with acceptance criteria.

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