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The UBS Ultrasonic Bone Surgery and the UDD Ultrasonic Debridment Device are bone cutting instruments intended for use in oral surgery.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "UBS Ultrasonic Bone Surgery and UDD Ultrasonic Debridment Device." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter is primarily a regulatory approval document, stating that the device can be marketed based on its substantial equivalence to existing devices. It does not delve into the specific technical studies or performance metrics typically found in clinical trial reports or validation studies for AI/ML devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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