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The American Electromedics Race Car Tympanometer/ Audiometer With Integral Printer is intended to be used in conducting hearing evaluations and assisting in the diagnosis of possible otologic disorders.

The American Electromedics Race Car Tympanometer/Audiometer With Integral Printer is a combination device which can be used as a tympanometer or as an audiometer, and has a built-in printer.

This is a 510(k) premarket notification for a medical device (Tympanometer/Audiometer), which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specified acceptance criteria and human evaluation. The provided text does not contain the detailed information required for the requested output regarding acceptance criteria and a study proving device performance in the context of AI or human reader improvement.

Therefore, I cannot fulfill your request as the necessary data is not present in the provided text. The document describes the device, its intended use, and its classification, and notes that it is substantially equivalent to previously marketed devices (K970279). It does not detail specific performance metrics, clinical trials, or expert-based evaluations in the way an AI-driven diagnostic device might.

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