(135 days)
For promotion of good oral hygiene, including the reduction of dental plaque and gingivitis.
Sonicare® Advance Model 4900 consists of three primary parts: brush head, power handle, and charger base. Central to the brush head are the resonator arm and the torsion bar. The brush head's bristles are mounted in a bristle plate on one end of the arm, two magnets are mounted on the other, and the torsion bar is perpendicular in the middle. A 261-Hz oscillating magnetic flux generated inside the power handle forces the magnets into motion, which then causes the resonator arm to oscillate about the torsion bar. The torsion bar, magnets and bristle plate have a resonant frequency close to the 261-Hz driving frequency, and this enables the system to produce a desired amplitude effect. The bristles vibrate in the direction perpendicular to the bristles' length and nominally perpendicular to the brush's axis.
The oscillating magnetic flux is generated by a stator coil in the power handle, in close proximity to the attachment of the brush head. The flux is controlled by solid-state electronics and powered from two nickel-cadmium rechargeable batteries elsewhere within the handle. Energy for recharging the batteries is transferred from the charger base through a system of induction coils within the power handle and the charger base. Maximum power dissipation by the handle is 3 W.
The charger base runs on standard North American 120 V, 60 Hz power. Internal electronics convert the input power to a 65 kHz output signal for more efficient transfer of power to the handle.
The provided text does not contain specific acceptance criteria in a quantitative or tabular format for the Sonicare® Advance Toothbrush (Model 4900). Instead, the submission relies on demonstrating substantial equivalence to predicate devices through clinical trials.
Below is a summary of the information available regarding the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria. Instead, it states that "the studies demonstrate that the Sonicare® Advance toothbrushes reduce gingivitis." This implies that the acceptance criteria were met if the clinical trials showed a statistically significant reduction in gingivitis and no evidence of injury to soft tissues.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Promotion of good oral hygiene | Supported by clinical trials |
| Reduction of dental plaque | Not explicitly stated as a separate endpoint in the summary, but implied by 'promotion of good oral hygiene'. |
| Reduction of gingivitis | Studies collectively demonstrate reduction of gingivitis |
| No evidence of injury to soft tissues | Evaluated in trials, no adverse findings reported |
| Substantial equivalence to predicate devices | Concluded based on testing results and comparison |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "a total of seven clinical trials (six controlled)."
- Data Provenance: Not explicitly stated, but clinical trials typically involve human subjects. The fact that the device is marketed in North America (charger base runs on standard North American 120 V, 60 Hz power) might suggest studies were conducted in relevant regions, but this is an inference. The studies are prospective in nature as they are clinical trials evaluating device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The clinical trials would have involved dental professionals, but their specific number, roles in establishing "ground truth," or qualifications are not detailed in this 510(k) summary. Given the endpoints (gingival inflammation, pocket probing depth, clinical attachment level, soft tissue injury), the experts would likely be dentists, periodontists, or dental hygienists.
4. Adjudication method for the test set:
This information is not provided.
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:
This is irrelevant; the device is a toothbrush, not an AI-powered diagnostic tool requiring human reader involvement or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is irrelevant; the device is a toothbrush, not an algorithm. Performance is assessed through its physical interaction and biological effect on users.
7. The type of ground truth used:
For the clinical trials, the "ground truth" would have been established through:
- Clinical Examination/Indices: Measurement of gingival inflammation (e.g., using gingival indices), pocket probing depth, and clinical attachment level by trained dental professionals.
- Visual Assessment: Examination of soft tissues for evidence of injury.
8. The sample size for the training set:
This is irrelevant; the device is a physical toothbrush, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This is irrelevant; the device is a physical toothbrush, not a machine learning model.
§ 872.6865 Powered toothbrush.
(a)
Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is 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.