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This product may be used for any defect in the ossicular chain of the middle ear, injury or congenital malformation.

CAUSSE UNIVERSAL HA PROSTHESIS (formerly 'Causse Universal Ossicular Replacement Prosthesis)

This is an FDA Premarket Notification (510(k)) K963899 for a medical device called the "Causse Universal Ossicular Replacement Prosthesis," later renamed "Causse Universal HA Prosthesis." The document is an approval letter from the FDA dated August 22, 1997, confirming that the device is substantially equivalent to legally marketed predicate devices.

The provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. The document is a regulatory approval letter, not a technical report detailing the device's validation studies.

Therefore, I cannot fulfill your request for that specific information based on the provided text.

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