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Kartush TM Patcher is intended for use as a patch to aid coverage of a tympanic membrane perforation in a dry ear.

The Kartush TM Patcher is comprised of a double flange design, using silicone elastomer as the biocompatible material. The configuration is similar to a collar button style tympanostomy tube, with the exception that no through-hole or lumen is present. A variety of sizes or diameters of the TM Patcher will be available for approximating different size perforations. Alternately, the TM Patcher may be trimmed to size by the surgeon to fit the existing perforation. The flange thickness is the same as silicone sheeting currently used to treat TM perforations. The soft, pliable flange, which can conform to the surface of the TM, also easily folds for removal of the device as needed. As with nasal septal buttons, the silicone elastomer material is the same as used in the manufacture of Xomed tympanostomy tubes.

The provided 510(k) summary for the Kartush TM Patcher is for a medical device (a patch for tympanic membrane perforations) and does not contain information about acceptance criteria or a study proving that a device, particularly an AI-powered one, meets those criteria.

The document describes the device, its intended use, and argues for substantial equivalence to existing devices. It does not mention any performance metrics, studies with test sets, expert ground truth, or any of the other details relevant to AI algorithm validation that you've asked for.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided text. The submission is from 1996, well before the widespread use of AI in medical devices, and focuses on the physical design and material safety of an implantable patch.

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