(86 days)
The intended use of the Unik Tongue Cleaner is to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene.
This is a device consisting of a molded polypropylene plastic handle, similar in appearance to that of a toothbrush, and a U-shaped loop end made of either polypropylene plastic or stainless steel. The device is used by placing the loop end at the back of the tongue and gently dragging it toward the front. The device is designed so that there are no sharp edges.
This document is a 510(k) premarket notification for a medical device called the "Unik Tongue Cleaner." It primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device rather than presenting a study for acceptance criteria.
Therefore, many of the requested sections regarding acceptance criteria and a study proving device performance cannot be extracted because such a study is not part of this 510(k) submission. 510(k) submissions for devices like tongue cleaners typically rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies with specific performance metrics.
Here's what can be extracted based on the provided text, and where fields cannot be filled due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in a Study) | Reported Device Performance (from a Study) |
|---|---|
| Not applicable - no specific performance acceptance criteria are defined or reported in a study. | Not applicable - no performance metrics from a study are reported. |
Explanation: The document does not define specific quantitative acceptance criteria (e.g., a certain percentage reduction in plaque, or a specific level of bacteria removal) that a study would then need to meet. Instead, the "acceptance criteria" for a 510(k) submission for this type of device are met by demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness principles.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not applicable, as no dedicated performance study (clinical or otherwise with a test set) is described.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This device is a physical tongue cleaner and does not involve AI or human readers for diagnostic interpretation.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a physical tongue cleaner and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable, as no performance study requiring ground truth is described. The "ground truth" equivalent in a 510(k) for this device is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable, as no AI/algorithm training is involved.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for a 510(k) submission):
The "study" in this context is the substantial equivalence comparison to the predicate device, not a performance study quantifying specific metrics.
- Comparison Basis: The Unik Tongue Cleaner is compared to the Breath-So-Fresh Tongue Cleaner (K972644).
- Key Arguments for Substantial Equivalence:
- Same Intended Use: Both devices are intended "to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene."
- Similar Technological Characteristics: Both employ a handle and a loop end to gently scrape the tongue.
- Similar Operating Principle: Both use a U-shaped loop (or spoon-shaped in the predicate) to scrape bacteria and plaque from the tongue surface.
- Similar Use Manner: Both are used by placing the loop end at the back of the tongue and gently dragging it forward.
- Differences Acknowledged:
- Loop Shape: Unik Tongue Cleaner has a U-shaped loop; Breath-So-Fresh is spoon-shaped. (This is deemed not to raise new safety/effectiveness issues.)
- Materials: Unik Tongue Cleaner can be all plastic or plastic handle with stainless steel loop; Breath-So-Fresh is entirely plastic. (This is also deemed not to raise new safety/effectiveness issues.)
- Conclusion: The submission concludes that because the Unik Tongue Cleaner has the same intended use, similar design, and is used in the same manner as the predicate device, it introduces no new safety or effectiveness issues and is therefore substantially equivalent.
This type of submission relies on the FDA's regulatory framework for 510(k)s, where new clinical data or specific performance metrics are not always required if substantial equivalence to a legally marketed device can be demonstrated.
§ 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.