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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.

• 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.

• 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.

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ToothWave™ is indicated as follows:

ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.

The ToothWave™ is a handheld rechargeable electric toothbrush intended to promote oral hygiene, including reduction in plaque and prevention and treatment of gingivitis. The device is for over-the-counter (OTC) use. The device is comprised of the handle, the brush head, and recharging unit. The device utilizes radiofrequency (RF) energy and tactile vibration. The device is operated by a single-mode push button located on the handle/user interface board and includes a set of light indicators informing the user of the device operation (RF activation, vibration level, charging, or error).

The request concerns the ToothWave™ device, a radiofrequency toothbrush. The provided text outlines the device's technical specifications, non-clinical/bench studies, and clinical studies to demonstrate its safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the "Special Controls" section, which outlines requirements for performance testing, label comprehension, usability, biocompatibility, electrical/thermal/safety testing, software validation, and labeling content. The "SUMMARY OF NONCLINICAL/BENCH STUDIES" and "SUMMARY OF CLINICAL INFORMATION" detail how the device's performance meets these criteria.

2. Sample Size Used for the Test Set and Data Provenance

The primary clinical efficacy and safety study ("Safety and Efficacy of the ToothWave™ Toothbrush...") had a test set (randomized subjects, ITT Analysis Set) of 86 subjects: 45 in the treatment group (ToothWave™) and 41 in the control group.

The usability study component used the 45 subjects from the treatment group of the efficacy study.

The self-selection study involved 10 subjects (5 potential end users and 5 contraindicated subjects).

Data Provenance: The text does not explicitly state the country of origin for the clinical study data, but the sponsor information is Home Skinovations Ltd. in Yoqneam Illit, ISRAEL. The study type was a prospective, single-blinded, double-arm randomized study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

For the clinical efficacy study, "Efficacy was evaluated by examiners trained in the assessment of gingivitis, dental plaque and calculus." The exact number of examiners is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the statement implies qualified personnel performed the assessments to establish ground truth for plaque, calculus, and gingivitis indices.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for disagreements among experts (e.g., 2+1, 3+1). The efficacy assessments were performed by "examiners," implying a standard protocol, but no specific adjudication process is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The primary clinical study compared the device (ToothWave™) to a control power toothbrush, not human readers with and without AI assistance. The study focused on the effectiveness of the device itself in reducing plaque, calculus, and gingivitis.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) performance study was not conducted. The ToothWave™ is a medical device (a toothbrush) that is used by a human. Its efficacy is directly tied to human use (brushing twice daily). The clinical study evaluated the device's performance in human subjects using it.

7. Type of Ground Truth Used

For the clinical efficacy study, the ground truth was established by expert assessment using validated clinical indices:

• Plaque: Navy Plaque Index (RMNPI)
• Calculus: Volpe-Manhold Index (V-MI)
• Gingivitis: Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI)

These are objective clinical measures assessed by trained examiners.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI algorithms for establishing device performance. The non-clinical and clinical studies are focused on validating the device's physical and functional capabilities and its effectiveness in human use. If "training set" refers to data used to develop the device or its software, that information is not provided. The software section mentions "software verification & validation," which relates to quality assurance for the finished software, not a training phase for a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, there is no mention of a "training set" in the context of an AI/ML algorithm within the provided text. The device's performance and safety were evaluated through bench testing and clinical trials, not through an AI model that requires a labeled training set for its development.

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