(392 days)
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.
| Acceptance Criterion (Special Controls) | Reported Device Performance (Summary of Studies) |
|---|---|
| Non-clinical performance testing: Demonstrated performance as intended under anticipated conditions of use. | Temperature Tests: All tests (Skin/Tissue Temp, Dental Structures, Toothpaste Temps) PASSED. Demonstrated RF current does not significantly increase local temperature (within 35-37°C for tissue, below 42°C for dental structures, below 30°C for toothpaste) even with static, continuous attachment. |
| - Validation of RF performance specs (output power, voltage, freq, pulse cycle, waveform, duration) | RF Generator Test: PASSED. Verified working frequency range, input/output voltage, output frequency, and output power under load and no-load conditions met design specs (3MHz ±0.3MHz; up to 3W). |
| - Temperature performance testing (device, oral cavity structures, toothpaste) | Temperature Tests: As above, all PASSED with temperatures remaining within safe limits. |
| - Assessment of mechanical output specs and physical properties (vibration freq, tuft retention, brush head strength, battery voltage) | Motor Driver Test: PASSED. Demonstrated ability to apply different modes (275Hz, 300Hz, 400Hz) and output measurements within specification limits. |
| Brush Head Worst Case Lifetime Test: PASSED. Conforti index score of 1 (light wear) for bristles after 3 months, bristles, RF electrodes, and silicone barrier remained in place. | |
| Durability of Electric RF Toothbrush Test: PASSED. Device functioned as intended with no excessive wear or damage after simulated use life (brush head 3 months, handle 5 years). | |
| - Use life and durability testing | Shelf Life/Sterility: Handle life 5 years, brush head 3 months (life time test demonstrated durability). |
| Brush Head Worst Case Lifetime Test: As above. | |
| Durability of Electric RF Toothbrush Test: As above. | |
| Label comprehension and self-selection study: Demonstrated intended user population can understand labeling and correctly choose device. | TOOTHWAVE USABILITY & SELF-SELECTION CLINICAL STUDY: PASSED. All 55 participants demonstrated labeling comprehension. In the self-selection study, 5 intended users correctly identified themselves, and 5 contraindicated subjects successfully self-excluded. |
| Usability performance evaluation: Demonstrated user can safely and correctly use the device. | TOOTHWAVE USABILITY & SELF-SELECTION CLINICAL STUDY (Usability evaluation): PASSED. All 45 eligible subjects identified themselves as potential users and completed device tasks without assistance or adverse events. Post-treatment questionnaires indicated ease of understanding and use. |
| Biocompatibility: Patient-contacting components demonstrated to be biocompatible. | BIOCOMPATIBILITY/MATERIALS: PASSED. Tests (Cytotoxicity, Sensitization, Irritation) supporting biocompatibility were performed on final finished device components (toothbrush body/brush head, silicon barrier, RF brush head electrodes, bristles) per ISO 10993-1, -5, -10. |
| Electrical safety, thermal safety, mechanical safety, battery safety, and electromagnetic compatibility (EMC) testing. | ELECTROMAGNETIC CAPABILITY & ELECTROMAGNETIC SAFETY: PASSED. Complied with IEC 60601-1-2 (EMC), AAMI/ANSI 60601-1 (Electrical Safety), and numerous other relevant IEC/EN standards. Thermal safety addressed in Temperature Tests and Device Specifications. Mechanical safety addressed in Mechanical and Lifetime Performance Tests. Battery safety implicitly covered by Electrical Safety and compliance with IEC 62133. |
| Software verification, validation, and hazard analysis. | SOFTWARE: Level of Concern "Moderate". Verification and validation testing demonstrated software's ability to control user interface, check hardware status, etc., complying with FDA guidance. Hazard analysis (mentioned in "RISKS TO HEALTH" table under Thermal Injury mitigation) was performed. |
| Labeling criteria: Information on device operation, technical specs, warning re: dentist visits, cleaning/maintenance, use life/disposal. | LABELING: Sponsor provided user manual and packaging label with all required information, including revised contraindications, home-use specifics, warning about regular dentist visits, guidance for physician/dentist consultation, cleaning/maintenance, and technical specifications. |
| Clinical Efficacy (Primary Endpoint): Significant reduction from baseline in average scores of plaque and gingivitis compared to an ADA-accepted power toothbrush after 6 weeks. | TOOTHWAVE DEVICE EFFICACY AND SAFETY CLINICAL STUDY: PASSED. After 6 weeks, the ToothWave™ group showed statistically significant reductions in MGI (gingivitis) and RMNPI (plaque) compared to the control group. Deltas (mean percent change) were -44.99% for MGI and -25.19% for RMNPI, significantly better than control (-31.35% for MGI, -14.93% for RMNPI). |
| Clinical Efficacy (Secondary Endpoint): Significant reduction from baseline in calculus in the treatment group following 6 weeks. | TOOTHWAVE DEVICE EFFICACY AND SAFETY CLINICAL STUDY: PASSED. Post-hoc analysis showed 2% accumulation of tartar in the treatment group vs. 14% in control group, indicating a significant reduction/prevention. |
| Clinical Safety: No device-related adverse events. | TOOTHWAVE DEVICE EFFICACY AND SAFETY CLINICAL STUDY: PASSED. "No device related adverse events were reported during the study." Also, a separate "TOOTHWAVE SAFETY (HIGH VIBRATION SPEED) CLINICAL STUDY REPORT" found no adverse events over 6 weeks. |
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.
§ 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.