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But er's Antibacterial Power Toothbrushes are devices that include a handle to be held in the hand and bris les (filaments) at one end to remove adherent plaque and food debris from the teeth to reduce too h decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on : nd between the bristles between uses.

The nylon bristles of the Butler GUM® Vati-Clean™ Toothbrush are impregnated with silver, which provides long-lasting antibacterial protection of the bristles.

The provided document is a 510(k) premarket notification for a medical device, specifically a powered toothbrush. It concerns the substantial equivalence determination for the "Butler GUM® Vari-Clean™ Power Toothbrush."

The document does not contain acceptance criteria or detailed study information typically found in performance studies for medical devices. The primary purpose of this 510(k) submission is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device, not to present novel performance data against specific acceptance criteria.

Therefore, I cannot provide the requested information from the provided text for the following reasons:

• No Acceptance Criteria: The document does not define any specific performance metrics or thresholds for the Butler GUM® Vari-Clean™ Power Toothbrush that would be considered "acceptance criteria."
• No Performance Study: There is no description of a study conducted to demonstrate the device meets any performance criteria. The submission relies on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use.
• No Data on Test Sets, Experts, Adjudication, MRMC, or Ground Truth: Since no performance study is described, there is no information regarding sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, or the type of ground truth used.
• No Information on Training Set: Similarly, for devices relying on demonstrating substantial equivalence, information about training sets for algorithms is not typically present as the device's function is not based on a machine learning model that requires training.

The document mainly focuses on:

• Identifying the applicant and device.
• Describing the device's technological characteristics (nylon bristles impregnated with silver for antibacterial protection).
• Stating its intended use (over-the-counter toothbrush, with antibacterial agent on bristles).
• Identifying a predicate device (Medoral Hygienic Toothbrush, K020776) and arguing for substantial equivalence based on identical bristles.
• The FDA's decision letter confirming substantial equivalence.

In summary, the provided text does not contain the information required to answer your request about acceptance criteria and performance studies. This type of information is typically found in clinical trial reports or detailed performance validation studies, which are not present in this 510(k) summary.

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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.

Ask a specific question about this device