(84 days)
The Medoral Hygienic Toothbrush with DENTOSAN® Filaments is a toothbrush to remove plaque and debris from the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.
The Medoral Hygienic Toothbrush is a toothbrush with DENTOSAN® filaments. The DENTOSAN® filament is a nylon filament impregnated with an anti bacterial agent to prevent the growth of bacteria on and between the filaments after use of the toothbrush.
The provided text refers to a 510(k) summary for a "Medoral Hygienic Toothbrush with DENTOSAN® Filaments," a manual toothbrush with antibacterial properties. The summary describes the device, its intended use, and its technological characteristics. It also states that "The effect of the antimicrobial agent was tested and found to be effective using worst case testing for useful life, simulated use extraction testing and antimicrobial effectivity. Additionally, the filament was determined to be biocompatible using the methods recommended in ISO 10993 Biological Testing of Medical and Dental Materials and Devices."
However, the provided document does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria in the format requested.
Here's an attempt to answer the questions based only on the provided text, highlighting the missing information:
1. A table of acceptance criteria and the reported device performance
The document mentions "worst case testing for useful life, simulated use extraction testing and antimicrobial effectivity." It also states "The antimicrobial agent used is the DENTOSAN® filament does not raise any new safety or effectiveness concerns." and "The biocompatibility and effectiveness of the antibacterial agent was tested using established scientific methods and test protocols."
However, it does not provide specific numerical acceptance criteria (e.g., "bacterial reduction by X%") or the reported device performance data against those criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not applicable as the device is a toothbrush, and the testing described (antimicrobial effectivity, biocompatibility) typically involves laboratory assays rather than expert interpretation of images or clinical outcomes in the usual sense of "ground truth" for medical imaging AI. Therefore, no experts would be establishing "ground truth" in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the relevant studies described are laboratory-based antimicrobial and biocompatibility tests, not studies requiring human adjudication of results.
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
An MRMC study is not applicable or mentioned for this device. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images, where AI might assist readers. This device is a manual toothbrush.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to a manual toothbrush. It refers to AI-driven algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the antimicrobial effectiveness, the "ground truth" would likely be established by quantitative measurements of bacterial reduction using standardized microbiology laboratory methods (e.g., colony forming units count).
For biocompatibility, the "ground truth" is established by validated biological assays as per ISO 10993, comparing the device's material with established safety benchmarks.
The document does not explicitly detail these "ground truth" methods but refers to "established scientific methods and test protocols" and ISO 10993.
8. The sample size for the training set
This question is not applicable to this device. A "training set" is relevant for machine learning or AI models, which are not described or implied for this manual toothbrush.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as point 8.
§ 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.