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510(k) Data Aggregation
(209 days)
PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER
The proSonic™ Ultraviolet Toothbrush Sanitizer is intended for use in reducing bacterial contamination that naturally accrues on toothbrushes under normal conditions of use.
The proSonic Ultraviolet Toothbrush Sanitizer unit sanitizes toothbrushes hung inside the unit by reducing the amount of bacteria that accrues on them under normal conditions of use. Sanitization is accomplished via ultraviolet (UV) radiation produced by a UV lamp housed within the unit. When activated, the proSonic Ultraviolet Toothbrush Sanitizer completes an initial sanitization cycle in one (1) hour. Afterwards, a built-in timer in the unit alternately causes the UV lamp to be turned off for sixty (60) minutes and turned on for five (5) minutes in between brushing cycles. Depending on usage, the UV lamp will typically be activated for approximately one hundred-sixty five (165) minutes per day. The bulb has an effective Iife of ten thousand (10,000) hours. The sanitizer is designed so that the UV lamp can be activated only when the unit door is fully closed, and the level of ozone emitted by the sanitizer is within FDA regulatory limits. The proSonic Ultraviolet Toothbrush Sanitizer is sold with four (4) accompanying toothbrushes and a power handgrip (which converts the toothbrushes into powered toothbrushes).
Here's a breakdown of the acceptance criteria and study information for the Prosonic™ Ultraviolet Toothbrush Sanitizer based on the provided document:
This document is a 510(k) premarket notification for a medical device seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that the device is "as safe, as effective, and performs as well as or better than" the predicate. Therefore, the "acceptance criteria" presented are implicitly derived from the performance of the predicate and the general safety standards for similar devices. There isn't a clearly defined set of numerical acceptance criteria like you would typically find for a more novel device performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Prosonic™ Ultraviolet Toothbrush Sanitizer) |
|---|---|
| Bacterial Contamination Reduction: Significant reduction in bacterial contamination on toothbrushes. | "bacterial contamination on toothbrushes is significantly reduced by the device" |
| Ozone Emissions: Within FDA regulatory limits (specified at 21 C.F.R. § 801.415). | "the ozone emitted by this product is minimal and within limits specified at 21 C.F.R. § 801.415 (2002)." |
| Safety Feature (Door Interlock): UV lamp can only be activated when the unit door is fully closed. | "The sanitizer is designed so that the UV lamp can be activated only when the unit door is fully closed." |
| Material and Design Equivalence: Substantially equivalent to the predicate device. | "Both devices are substantially equivalent in terms of materials and design." |
| Technological Characteristics: Substantially equivalent to the predicate device (e.g., uses UV light, similar ozone emissions, similar UV bulb wavelengths). | "Both the proSonic and the Purebrush sanitizers use ultraviolet light to reduce bacterial contamination. ... Ozone emissions for the two devices are similar... The UV lamps in both devices cannot be activated unless the units are fully closed. The wavelengths emitted by the UV bulbs in the two devices are also substantially equivalent." |
| Effective UV Lamp Life: (Predicate's effective life) | "The bulb has an effective life of ten thousand (10,000) hours." (While different from the predicate, this difference is stated to "not significant to the safety or effectiveness.") |
| Sanitization Cycle Length: (Predicate's cycle length) | "completes an initial sanitization cycle in one (1) hour." (While different from the predicate, this difference is stated to "not significant to the safety or effectiveness.") |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Laboratory and actual use tests" were conducted but does not provide specific numbers of toothbrushes, test subjects, or samples examined for bacterial reduction or ozone emission.
- Data Provenance: The study was conducted for Hwadong International Company, Ltd., which is based in Korea. The document does not specify if the testing itself was performed in Korea, the US, or elsewhere, nor does it explicitly state if the data was retrospective or prospective. Given the context of a premarket notification for a new device, it is most likely prospective testing specifically performed for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/not specified. For bacterial reduction and ozone emissions, the ground truth would be based on objective laboratory measurements rather than expert consensus. No specific experts are mentioned as establishing ground truth in this context.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. Since the measurements are objective (bacterial counts, ozone levels), there wouldn't typically be a separate adjudication process for ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study relates to the performance of human readers (e.g., radiologists) with and without AI assistance, which is not relevant to a physical device like a toothbrush sanitizer.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, in essence. The entire evaluation focuses on the performance of the device itself ("algorithm only" in a conceptual sense for a physical product) in reducing bacteria and emitting ozone, without human intervention or human-in-the-loop performance being a factor in the device's function or evaluation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for bacterial reduction would be based on microbiological assay results (i.e., direct counts of bacterial colonies from samples before and after sanitization). The ground truth for ozone emissions would be based on chemical analysis/sensor readings using established testing protocols to detect and quantify ozone levels. These are objective laboratory measurements.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. This device is a physical product, not an AI/ML algorithm that requires a "training set" in the computational sense. The "development" of the device would involve engineering and physical testing, not data training.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. See point 8.
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