(21 days)
The Germ Terminator Toothbrush Sanitizer is designed to sanitize up to two manual toothbrushes or two toothbrush heads between uses. The Germ Terminator Toothbrush Sanitizer is intended for home use and will be available "over the counter."
The Germ Terminator uses steam heat to sanitize two manual toothbrushcs or two toothbrush heads. Water is poured into a reservoir in the device's housing and it is heated to its boiling point. Water is thereby converted into steam, which sanitizes the toothbrushes in the housing. The stcam cycle is followed by a drying cycle.
The provided text describes a 510(k) premarket notification for the "Germ Terminator Toothbrush Sanitizer." It details the device's function, intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to fill out the requested table and answer all the questions about acceptance criteria and a study proving device performance as a medical device in the typical sense of AI/algorithm performance.
The submission is for a physical device (toothbrush sanitizer), not an AI/algorithmic medical device, which is why much of the requested information (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not present in the document.
The document indicates "Laboratory testing demonstrated that toothbrushes treated in the Germ Terminator are effectively sanitized," but it does not provide the specifics of this testing in terms of acceptance criteria or performance metrics beyond this general statement.
Therefore, I will extract what information is available and explicitly state where the requested information is absent or not applicable to this type of device submission.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sanitization Efficacy | "Testing demonstrated that the toothbrushes treated in the Germ Terminator were sanitized." |
| "Laboratory testing demonstrated that toothbrushes treated in the Germ Terminator are effectively sanitized." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document. The document only states "Laboratory testing."
- Data Provenance: Not specified in the provided 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)
- Number of Experts: Not applicable. For a physical device like a toothbrush sanitizer, "ground truth" is typically established through microbiological testing standards and results, not via expert consensus on image interpretation or diagnosis.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for objective laboratory testing of sanitization efficacy.
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, an MRMC comparative effectiveness study was not done. This type of study is specific to imaging devices or AI algorithms where human readers interpret data, typically in a diagnostic context. This device is a physical sanitizer.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not applicable. This device is a physical sanitizing unit, not an algorithm. The "standalone" performance here refers to its inherent sanitization capability, which was reportedly tested in a lab.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Likely microbiological test results demonstrating the reduction or elimination of specific microorganisms. The document uses the general term "sanitized" which implies a measurable reduction in microbial load to a safe level, based on established public health standards for sanitization.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: 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.