(85 days)
To remove plaque and food particles from between the teeth as part of a comprehensive dental treatment program to reduce tooth decay and to treat and prevent gingivitis.
Crest Glide dental floss is a manual dental floss comprised of polytetrafluoroethylene monofilament fiber and a coating comprised of beeswax, gum arabic, water, flavor and other ingredients for color and cosmetic benefits. The floss was developed to improve ease of sliding between tight spaces to achieve effective plaque removal. Each of the materials that could come in contact with the user of this device is comprised of well-defined materials that are safe for use in the oral cavity.
The provided text is for a 510(k) premarket notification for a dental floss product (Crest Glide Dental Floss). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical performance against specific acceptance criteria for AI/ML-based medical devices.
Therefore, many of the requested fields regarding AI/ML device evaluation criteria (such as number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document.
Here's a breakdown of the applicable information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to existing legally marketed predicate devices and that the device is safe and effective for its intended use. Specifically, for the expanded indication of "treatment and prevention of gingivitis," the acceptance criterion appears to be showing that the addition of dental floss to toothbrushing is effective.
Reported Device Performance:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Glide Comfort Plus Dental Floss) | Crest Glide Dental Floss has the same design and manufacturing process as the currently marketed Glide Comfort Plus Dental Floss. The predicate is indicated for plaque removal and prevention of tooth decay. Crest Glide Dental Floss uses the same mechanism of action (mechanical removal of plaque). No new issues of safety or effectiveness. |
| Substantial Equivalence to Predicate Devices (Oral-B Toothbrush) | Currently marketed Oral-B Toothbrush is indicated for treating and preventing gingivitis and uses the same mechanism of action as Crest Glide Dental Floss (mechanical removal of plaque) to achieve this benefit. No new issues of safety or effectiveness. |
| Effectiveness for Treatment and Prevention of Gingivitis (Expanded Indication) when added to toothbrushing. | Data from four clinical trials collectively show the addition of dental floss to toothbrushing is effective at treatment and prevention of gingivitis via the physical removal of plaque. The floss treatments in these studies were well tolerated with no safety issues. |
2. Sample size used for the test set and the data provenance
The document references four clinical trials to support the expanded indication. The individual sample sizes for each study are not explicitly stated in this summary.
- Study 1: "Assessment of treatment responses to dental flossing in twins." J of Periodont; August 2006, 77(8):1386-91. (Specific sample size not provided)
- Study 2: "A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing." The University of Texas Health Science Center at San Antonio Dental School, USA. Study conducted in Guatemala. Final Study Report. (Specific sample size not provided. Provenance: Guatemala)
- Study 3: "Comparative effectiveness of flossing and brushing in reducing interproximal bleeding." J of Periodontol; May 1989; 60(5): 243-247. (Specific sample size not provided)
- Study 4: "Comparison of the use of different modes of mechanical oral hygiene in prevention of plaque and gingivitis." J of Periodontol; August 2008; 79(8): 1386-1394. (Specific sample size not provided)
The studies appear to be prospective clinical trials, given their titles and publication dates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a dental mechanical device, and the endpoint for clinical studies would typically involve objective measurements (e.g., plaque indices, bleeding scores) rather than subjective expert interpretation for "ground truth" in the AI/ML sense.
4. Adjudication method for the test set
Not applicable. This is a dental mechanical device; adjudication in the context of expert review for AI/ML ground truth is not relevant here. Clinical trial methodologies would have their own blinding and assessment protocols.
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 device is a manual dental floss, not an AI/ML diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual dental floss.
7. The type of ground truth used
The "ground truth" or primary outcome measures in these studies would likely be objective clinical parameters related to oral health, such as:
- Plaque scores/indices
- Gingival bleeding scores/indices
- (Potentially) Measures of inflammation or other periodontal health indicators.
These are direct clinical measurements, not expert consensus or pathology in the context of diagnostic imaging.
8. The sample size for the training set
Not applicable. This is a traditional medical device (dental floss), not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
§ 872.6390 Dental floss.
(a)
Identification. Dental floss is a string-like device made of cotton or other fibers intended to remove plaque and food particles from between the teeth to reduce tooth decay. The fibers of the device may be coated with wax for easier use.(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 § 872.9.