(58 days)
To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.
The Breath-So-Fresh tongue cleaner is molded to a modified "spoon-shape". One end of the tongue cleaner is a handle. The other end is shaped as the bowl of the spoon. The tongue cleaner is held as a spoon, except upside down. The end tip of the spoon end is mildly rippled but has no sharp edges. The total length of the Breath-So-Fresh tongue cleaner is seven inches long and the cleaner is one and one-fourth inches wide at the widest portion.
The Breath-So-Fresh tongue cleaner is composed of a hard white plastic, either a polycarbonate plastic or a plastic similar to polycarbonate. This plastic is flexible as well as durable and is well suited to dental applications. The tongue cleaner is designed so that there are no sharp edges to the plastic.
The provided text is a 510(k) summary for the "Breath-So-Fresh Tongue Cleaner," which is a traditional medical device (a tongue scraper) and not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "acceptance criteria" in this context would be the FDA's determination of substantial equivalence, which is granted if the device's intended use and technological characteristics are similar enough to a legally marketed predicate device such that it raises no new questions of safety and effectiveness.
Here's the relevant information that can be extracted from the provided text, structured to align as closely as possible with your request, even though the core AI/ML metrics are not present:
1. Table of Acceptance Criteria and the Reported Device Performance (as infered for a traditional device):
| Acceptance Criteria (for 510(k) Substantial Equivalence of traditional devices) | Reported Device Performance/Characteristics |
|---|---|
| Intended Use Equivalence: To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath. | Intended Use: "To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath." (Matches predicate devices implicitly) |
| Technological Characteristics Equivalence: Design, materials, and functional features should be substantially similar to predicate devices, or any differences should not raise new questions of safety or effectiveness. | Similar shape to "The Professional Tongue Cleaner" (handle, rounded portion for tongue). |
| Combines with a rippled cleaning edge, similar to "Oolitt Tongue Cleaner". | |
| Composed of hard white polycarbonate or similar plastic, flexible and durable, no sharp edges. | |
| Safety and Effectiveness: Does not raise new questions concerning safety or effectiveness compared to predicate devices. | The document implies that the device's design and materials are safe and effective for its intended use, as it is substantially equivalent to legally marketed predicate devices. No specific "performance metrics" in the typical sense (e.g., sensitivity, specificity) are reported for this type of device in a 510(k) summary. |
The remaining points (2-9) are specific to studies for AI/ML device performance and are not found or applicable in this 510(k) summary for a manual tongue cleaner. No clinical trials or performance studies with "test sets," "ground truth," or "experts" in the context of diagnostic accuracy are described. The regulatory review for this type of device relies on the comparison to predicate devices, not on de novo clinical performance studies.
§ 872.6855 Manual toothbrush.
(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.