(83 days)
To promote good oral hygiene including plaque removal and treating and preventing gingivitis.
The Oral-B® toothbrush is a manual toothbrush comprised of a shaft with synthetic bristles at one end. The bristles are arranged in a pattern to achieve effective mechanical plaque removal. Some of the bristle tufts have a wear indicator function. These Indicator bristles are colored with FDA approved colorant, FD&C Blue No. 2.
The provided text describes a 510(k) submission for an Oral-B® manual toothbrush, where the manufacturer is seeking to expand the indication for use to include "treating and preventing gingivitis." The core of the submission emphasizes that the device is substantially equivalent to legally marketed predicate devices, with no changes in material, design, or manufacturing process, but only an expanded indication.
However, the document does not contain specific acceptance criteria in a quantitative format (e.g., a specific percentage reduction in gingivitis or plaque). Instead, it states that numerous controlled clinical studies have been performed and "collectively, these studies demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque."
Therefore, it is not possible to construct a table of acceptance criteria and reported device performance as requested, because specific quantitative metrics and thresholds for acceptance are not detailed in the provided text.
Furthermore, the document primarily functions as a 510(k) summary and the FDA's response, rather than a detailed study report. As such, many of the specific details about the studies (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not present in the given text.
Based on the provided information, here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
As stated above, the document does not explicitly list quantitative acceptance criteria. Instead, it refers to a body of clinical evidence supporting the expanded indication. The reported "performance" is qualitative, indicating effectiveness in treating and preventing gingivitis and removing plaque.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Qualitative) |
|---|---|
[Specific quantitative metrics for plaque removal or gingivitis reduction are not provided in this document] | The Oral-B® manual toothbrush is "effective at treating and preventing gingivitis via the physical/mechanical removal of plaque." |
[Specific thresholds for safety endpoints are not provided] | "Safety was assessed," and the studies support the "safety and effectiveness." |
Study Details
Due to the nature of the provided document (a 510(k) summary and FDA letter), many of the specific study details are not available in the text.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available in the provided text. The document states "numerous controlled clinical studies" but does not provide specific sample sizes for these studies, their design (retrospective/prospective), or their geographic origin. The bibliography lists several clinical investigations but does not offer these details in the provided snippets.
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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 available in the provided text. This type of detail is typical for device performance studies involving interpretation, but for a manual toothbrush assessing plaque and gingivitis, the "ground truth" would likely be based on clinical measurements (e.g., Gingival Index, Plaque Index) performed by trained dental professionals rather than "experts establishing ground truth" in the diagnostic imaging sense. However, no specific details on the assessors or their qualifications are provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available in the provided text. Adjudication methods are typically relevant for studies where subjective assessments by multiple readers need to be reconciled, such as in diagnostic imaging. For clinical measurements of plaque and gingivitis, standard clinical protocols for measurement and inter-examiner reliability would be more typical, but no such details are provided.
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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 question pertains to AI-assisted diagnostic tools. The device in question is a manual toothbrush, which is a physical device, not an AI or diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As above, this question is for AI/software devices. The manual toothbrush is a standalone physical device. Its performance is its intrinsic mechanical action.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied Clinical Measurements/Outcomes: While not explicitly stated, for plaque removal and gingivitis improvement, the ground truth would be based on clinical indices and outcomes data (e.g., Gingival Index scores, Plaque Index scores, bleeding on probing, etc.) measured by trained dental examiners.
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The sample size for the training set:
- Not applicable. This question is typically for machine learning models. For a physical device like a toothbrush, there isn't a "training set" in the machine learning sense. The clinical studies establish its effectiveness.
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How the ground truth for the training set was established:
- Not applicable. As above, this refers to machine learning models.
Summary of available information regarding the "study that proves the device meets the acceptance criteria":
- Device: Oral-B® "sub-brand" manual toothbrush.
- Expanded Indication: To promote good oral hygiene including plaque removal and treating and preventing gingivitis.
- Proof basis: "Numerous controlled clinical studies" have evaluated the effectiveness of the manual brush at removing plaque and improving and maintaining gingival health, and assessed soft and hard tissue safety.
- Conclusion: These studies "demonstrate that Oral-B® manual toothbrushes are effective at treating and preventing gingivitis via the physical/mechanical removal of plaque." The information "supports the safety and effectiveness" and "substantial equivalence to the predicate devices without raising any new safety and effectiveness issues."
- Underlying studies: A bibliography lists several clinical investigations conducted from 1996 to 2007, some of which compare power toothbrushes to manual toothbrushes, or compare different manual toothbrushes. These titles suggest that the studies indeed focused on efficacy in plaque removal and gingivitis reduction.
In essence, the 510(k) relies on a body of existing clinical evidence to support the expanded indication, rather than presenting a single, new, dedicated study with detailed acceptance criteria and performance metrics for this specific submission. The FDA's approval indicates they found this collective evidence sufficient to establish substantial equivalence for the expanded indication.
§ 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.