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The SplatrFree Swangle 360 Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient.

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The provided text describes a 510(k) premarket notification for a medical device called the "SplatrFree Swangle 360 Disposable Prophy Angle." This document is a letter from the FDA informing the manufacturer that their device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies related to the device. The document is strictly an FDA clearance letter based on substantial equivalence to a predicate device, which for Class I general controls devices often means the regulatory burden for clinical performance data is minimal or non-existent in the 510(k) submission itself.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document focuses on regulatory clearance, not on a detailed scientific study demonstrating performance against specific criteria.

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To Remove adherent plaque and debris from the teeth and oral mucosa, to Reduce tooth decay in patients who are Physically unable to perform brushing. To Prevent Aspiration, which may be associated with mechanical brushing only in these patients.

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This document is a 510(k) clearance letter from the FDA for a device called "Agatha-A-H2010." It indicates that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot provide the requested information based on the provided text. The letter only confirms that the device can be marketed and specifies its intended use and regulatory class.

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Ask a specific question about this device