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Interdental Toothbrush Antibacterial The Butler intended to remove adherent plaque and food debris from between the teeth to reduce tooth decay. The addition of the antibacterial agent is intended to maintain the cleanliness of the interdental brush between uses and to have no effect on the user of the device.

Butler Antibacterial Interdental Toothbrush

The provided document is a 510(k) clearance letter from the FDA for a specific medical device (Butler Antibacterial Interdental Toothbrush, K974761). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain the detailed information required to answer your request about acceptance criteria and the study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication methods.
• Information on MRMC comparative effectiveness studies.
• Information on standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training set was established.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on a detailed performance study against specific acceptance criteria for a novel device. The letter simply confirms that the FDA reviewed the submitted notification and found the device substantially equivalent for its stated indications for use.

Therefore,Based on the provided text, I cannot complete the table or answer the questions regarding acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter confirming substantial equivalence, but it does not detail the specific performance studies, acceptance criteria, or ground truth establishment methods that would typically be associated with such a request for an AI/device performance study.

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