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510(k) Data Aggregation
(408 days)
The Klinly Ultrasonic Tongue Cleaner is indicated to reduce plaque, food debris, and bacteria from the surface of the tongue, and also to help fight bad breath and promote oral hygiene.
The Klinly Ultrasonic Tongue Cleaner is a battery-operated device intended to be used to supplement daily oral hygiene care. It operates on two (2) AAA Alkaline batteries. All user-contacting components of the Klinly Ultrasonic Tongue Cleaner are constructed of injection-molded plastics which have demonstrated substantially equivalent biocompatibility according to ISO 10993-1.
The Klinly Ultrasound Tongue Cleaner device is comprised of three principles of operation to supplement daily oral hygiene by tongue cleaning. The device has a tongue scraping head, which:
- (1) Operates manually as a standard manual tonque scraper
- (2) Produces a low-frequency tactile vibration at 233 Hz, and
- (3) Emits ultrasound pressure waves at 1.6 MHz frequency.
The acceptance criteria and the study proving the device meets them are described below for the Klinly Ultrasonic Tongue Cleaner.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Measured Outcome) | Performance Requirement (Implicit) | Reported Device Performance | p-value (Statistical Significance) |
|---|---|---|---|
| Breath Malodor Reduction | Significant reduction in breath malodor | 37% reduction in breath malodor | p=0.0002 |
| Tongue Plaque Reduction | Significant reduction in tongue plaque | 41% reduction in tongue plaque | p<0.0001 |
| Tongue Bacterial Count Reduction | Significant reduction in tongue bacterial count | 75% reduction in tongue bacterial count | p=0.0401 |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: N=19 male and female patients.
- Data Provenance: Prospective, single-center clinical study. The country of origin is not explicitly stated in the provided text.
3. Number of Experts and Qualifications for Ground Truth:
The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth for breath malodor, tongue plaque, or tongue bacterial counts. Given the nature of these measurements, it is likely that objective metrics or clinical assessments by trained dental professionals were used, but specific details are not provided.
4. Adjudication Method for Test Set:
The document briefly mentions that the study was "blinded." However, it does not specify an adjudication method like 2+1, 3+1, or similar for resolving discrepancies in measurements or observations. It implies that the assessments were made in a standardized clinical manner.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study evaluated the direct effectiveness of the device on patients, not the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical product (Ultrasonic Tongue Cleaner) that a human user operates. It is not an AI algorithm for diagnostic interpretation or image analysis; therefore, a standalone algorithm performance evaluation would not be relevant.
7. Type of Ground Truth Used:
The ground truth was established through direct measurements of clinical parameters in human subjects:
- Breath Malodor: Measured clinically (method not specified, but likely an objective score or instrument reading).
- Tongue Plaque: Measured clinically (method not specified, but likely a scoring system).
- Tongue Bacterial Count: Measured clinically (method not specified, but likely laboratory enumeration from samples).
8. Sample Size for Training Set:
This information is not applicable and not provided. The device is a physical product, not a machine learning model that requires a "training set" in the context of AI/ML. The clinical study of 19 patients serves as the performance evaluation for this device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as explained in point 8.
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