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THE ELEGANCE MS-10 (25K) ULTRASONIC SCALER IS DESIGNED FOR USE IN PROPHYLAXIS TREATMENTS PERIODONTIA , AND OTHER AREAS OF OPERATIVE DENTISTRY.

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The provided document is a 510(k) clearance letter from the FDA for the Elegance MS-10 (25k) Ultrasonic Scaler. It does not contain information about acceptance criteria, specific study designs, or performance data for a device meeting acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a predicate device, not necessarily on a study demonstrating it met specific acceptance criteria. A 510(k) submission typically includes a comparison to a legally marketed predicate device, addressing aspects like technological characteristics and performance, but it often does not involve the kind of detailed clinical study with acceptance criteria, ground truth, and expert evaluation described in your request for AI/medical imaging devices.

Therefore, I cannot provide the requested information from this document. The document confirms the device's clearance for marketing and its intended use, but it does not detail the specific performance metrics or studies you are asking for.

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