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The ExTT-101 is used for assessing the strength of pelvic floor muscles, teaching pelvic floor muscle exercises and for providing feedback during pelvic floor muscle exercises.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called ExTT-101 Perineometer. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training/test set details.

The letter is primarily focused on:

• Confirming that the device is "substantially equivalent" to legally marketed predicate devices.
• Listing the indications for use of the device.
• Outlining the regulatory responsibilities of the manufacturer (e.g., registration, labeling, good manufacturing practice, adverse event reporting).
• Providing contact information for various FDA offices.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study design/results based on the provided input.

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