(382 days)
The Silk'n Toothwave is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis.
The Silk'n Toothwave is intended for over-the-counter use.
The Silk'n Toothwave device (a.k.a Silk'n H7001 Powered Toothbrush) is a handheld, rechargeable, powered, radiofrequency toothbrush, an over-thecounter device, intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. The Silk'n Toothwave Device is comprised of the handheld, brush head and recharging units. The device utilizes radio frequency (RF) energy and vibration.
The Silk'n Toothwave is comprised of the handle, the brush head, and recharging unit. The brush head is designed with radiofrequency electrodes and bristles. The handheld unit contains the software, programming, and hardware necessary for the device to function. The device is operated by a push button for activation of the radiofrequency and vibration.
The Silk'n Toothwave device is operated by a single mode push-button located on the handle/hand piece user interface board and a set of light indicators informing the lay user of the device operation.
The Silk'n Toothwave device is designed as a rechargeable handheld electrical toothbrush comprised of the charging base unit and a rechargeable power handheld unit. The chargeable base unit is galvanically isolated from the handheld unit. The Silk'n ToothWave Device is electrically safe in accordance with medical device electrical safety standards (IEC 60601-1, IEC 60601-2-2 and IEC 60601-1-11).
The Silk'n ToothWave Device utilizes vibration and low power RF energy technologies. The action of the brush head has a vibration frequency up to 400Hz. The RF generator generates conductive RF energy at 3 MHz, with a maximal output power of 3W.
The handle or hand piece brush head is designed as a medium oval brush head and features an arrangement of bristles surrounding two low profile hidden RF electrodes and a silicon barrier located in-between the two electrodes. The handle or hand piece is equipped with an ON/OFF switch and indicator panel that indicates the device status (RF activation, vibration level, charging, or error).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Silk'n Toothwave device, structured according to your request.
Please note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It references past studies but does not detail the specific acceptance criteria and their direct fulfillment in the same way a full study report might. Therefore, some information requested (like specific numerical acceptance criteria for plaque/gingivitis reduction or the exact methodology for establishing ground truth for training data) is not explicitly present in this summary.
Acceptance Criteria and Reported Device Performance
The document describes the intended use of the Silk'n Toothwave device as promoting good oral hygiene, including reduction of plaque, and the prevention and treatment of gingivitis. The primary clinical study mentioned in this 510(k) pertains to the reduction of calculus.
| Acceptance Criteria (Implied by Intended Use / Study Focus) | Reported Device Performance (Primary Clinical Study) |
|---|---|
| Reduction of dental plaque | Not explicitly quantified in this 510(k) document |
| Prevention and treatment of gingivitis | Not explicitly quantified in this 510(k) document |
| Reduction of calculus (tested in supplemental study) | Statistical significance demonstrated in calculus reduction: |
- Control group (n=45): 7.7% reduction at 6 weeks, 11.26% at 12 weeks
- Test group (ToothWave, n=42): 2.6% reduction at 6 weeks, -1.47% at 12 weeks
(Note: The negative value for the test group at 12 weeks (-1.47%) might indicate a slight increase in calculus from baseline at 12 weeks, or more likely, represents a statistically insignificant change or an average that started in reduction but then didn't continue, while still being statistically significant compared to the control). |
Study Details
The provided 510(k) references several studies, primarily performed for a previous DeNovo application (DEN190039). The current submission includes an additional study specifically on calculus reduction.
2. Sample size used for the test set and the data provenance
-
Calculus Reduction Study (additional study in this 510(k)):
- Test Set Sample Size: 90 subjects (randomly assigned to either ToothWave or control brush).
- ToothWave group (test group): n=42
- Control group: n=45
- Data Provenance: Salus Research Centre, IN, USA. Prospective.
- Test Set Sample Size: 90 subjects (randomly assigned to either ToothWave or control brush).
-
Previous Studies (submitted in DEN190039 for plaque/gingivitis):
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document, but implied to be prospective based on the description of "single-blinded, double arm randomized prospective study" and "additional self-selection study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Calculus Reduction Study: The study was conducted by Kim (RDH, PHD) and Jeff Milleman (DDS, MPA). These are likely the experts who established the ground truth (e.g., conducted the Volpe-Manhold Index (V-MI) examinations). The exact number of examiners used for each subject is not specified (e.g., if both examined each subject or if one was primary).
- Qualifications: RDH (Registered Dental Hygienist), PHD, DDS (Doctor of Dental Surgery), MPA (Master of Public Administration).
- Previous Studies: Not specified in this document.
4. Adjudication method for the test set
- Calculus Reduction Study: The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes the V-MI examinations performed by the named experts.
- Previous Studies: Not specified in this document.
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
- No, an MRMC comparative effectiveness study was not done. This device is a powered toothbrush, not an AI diagnostic or assistance system for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical product (a toothbrush) that relies on direct human-in-the-loop operation. It is not an algorithm evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Calculus Reduction Study: Expert clinical assessment using the Volpe-Manhold Index (V-MI) for calculus measurements. This is a recognized clinical index.
- Previous Studies (Plaque/Gingivitis): Implied to be expert clinical assessment based on the study design (single-blinded, randomized prospective study for plaque and gingivitis). Specific indices are not mentioned in this summary but are standard for such studies.
8. The sample size for the training set
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" in this context would refer to the device development leading to its final design, which is not quantified in terms of a sample size.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" in the context of an AI/ML algorithm to establish ground truth for. The development of the device would involve engineering, safety testing, and pre-clinical studies, but not a "ground truth" for a training set in the way you're asking.
§ 872.6866 Radiofrequency toothbrush.
(a)
Identification. A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy 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 II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested, and detailed protocols must be provided for each test conducted:
(i) Validation of the radiofrequency performance specifications including output power, voltage output, radiofrequency, pulse cycle, waveform, and pulse duration;
(ii) Temperature performance testing to evaluate the temperature change of the device, structures of the oral cavity (including skin, tissue, and dental restorations), and toothpaste under worst-case conditions;
(iii) An assessment of mechanical output specifications and physical properties including vibration frequency, tuft retention, brush head strength, and battery voltage; and
(iv) Use life and durability testing.
(2) A label comprehension and self-selection study must demonstrate that the intended user population can understand the package labeling and correctly choose the device for the indicated use.
(3) Usability performance evaluation must demonstrate that the user can safely and correctly use the device, based solely on reading the directions for use.
(4) The patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Electrical safety, thermal safety, mechanical safety, battery safety, and electromagnetic compatibility (EMC) testing must be performed.
(6) Software verification, validation, and hazard analysis must be performed.
(7) Labeling must include:
(i) Information on how the device operates, including images or illustrations;
(ii) A detailed summary of the device technical specifications;
(iii) A warning which states that the use of this device is not a substitute for regular visits to a dentist for routine clinical care;
(iv) Instructions on how to clean and maintain the device; and
(v) The use life and disposal of the components of the device.