(76 days)
The Zeodyne Toothbrush with AgION™ Antimicrobial is intended to remove adherent plaque and food debris from the teeth. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatment is not intended to have any effect on the user.
The Zeodyne Toothbrush with AgION antimicrobial is a manual toothbrush consisting of a shaft with synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth. The toothbrush contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses, maintaining the cleanliness of the brush.
The Zeodyne Toothbrush with AgION antimicrobial consists of a polymer based handle and either Nylon 6-12 or polybutylene terephthalate (PBT) bristles. The bristles contain 0.5% AgION antimicrobial.
The provided text describes a 510(k) premarket notification for a toothbrush, not an AI/ML device. Therefore, the questions related to AI/ML device performance, ground truth, expert opinions, and training/test set sample sizes are not applicable to this document.
However, I can extract information related to the device's functional performance criteria (as implied by its "antimicrobial" claim) and the study that supports it.
Here's the relevant information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Prevent bacterial growth on the toothbrush between uses | Laboratory studies for plastic bristle fibers containing AgION antimicrobial have shown that the product reduces the growth of bacteria on the surface of the fiber. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "Laboratory studies," but does not specify the sample size for these studies.
- The provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). It simply states "Laboratory studies."
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)
- Not applicable as this is not an AI/ML device and the ground truth for antimicrobial efficacy is typically established through standardized microbiological tests, not expert consensus on human-interpreted data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The "study" here refers to laboratory tests of the antimicrobial efficacy, not a diagnostic or interpretive task that would require adjudication.
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
- Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical product (toothbrush) with an antimicrobial agent. Its performance is inherent to the substance, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the antimicrobial efficacy is based on whether the "product reduces the growth of bacteria on the surface of the fiber," which implies microbiological laboratory measurements and potentially quantitative bacterial count reduction compared to controls. The antimicrobial agent itself is registered with the EPA as a bacteriostat, suggesting established methods for proving such claims.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 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.