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The proSonic™ Ultraviolet Toothbrush Sanitizer is intended for use in reducing bacterial contamination that naturally accrues on toothbrushes under normal conditions of use.

Device Description

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).

AI/ML Overview

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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K Number

K021258

Device Name

GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER

Manufacturer

GERM TERMINATOR CORPORATION

Date Cleared

2002-05-10

(21 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K003517

Intended Use

The Germ Terminator Toothbrush Sanitizer is designed to sanitize up to two manual toothbrushes or two toothbrush heads between uses. The Germ Terminator Toothbrush Sanitizer is intended for home use and will be available "over the counter."

Device Description

The Germ Terminator uses steam heat to sanitize two manual toothbrushcs or two toothbrush heads. Water is poured into a reservoir in the device's housing and it is heated to its boiling point. Water is thereby converted into steam, which sanitizes the toothbrushes in the housing. The stcam cycle is followed by a drying cycle.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Germ Terminator Toothbrush Sanitizer." It details the device's function, intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to fill out the requested table and answer all the questions about acceptance criteria and a study proving device performance as a medical device in the typical sense of AI/algorithm performance.

The submission is for a physical device (toothbrush sanitizer), not an AI/algorithmic medical device, which is why much of the requested information (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not present in the document.

The document indicates "Laboratory testing demonstrated that toothbrushes treated in the Germ Terminator are effectively sanitized," but it does not provide the specifics of this testing in terms of acceptance criteria or performance metrics beyond this general statement.

Therefore, I will extract what information is available and explicitly state where the requested information is absent or not applicable to this type of device submission.

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Sanitization Efficacy	"Testing demonstrated that the toothbrushes treated in the Germ Terminator were sanitized."
"Laboratory testing demonstrated that toothbrushes treated in the Germ Terminator are effectively sanitized."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided document. The document only states "Laboratory testing."
Data Provenance: Not specified in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable. For a physical device like a toothbrush sanitizer, "ground truth" is typically established through microbiological testing standards and results, not via expert consensus on image interpretation or diagnosis.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for objective laboratory testing of sanitization efficacy.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is specific to imaging devices or AI algorithms where human readers interpret data, typically in a diagnostic context. This device is a physical sanitizer.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance Study: Not applicable. This device is a physical sanitizing unit, not an algorithm. The "standalone" performance here refers to its inherent sanitization capability, which was reportedly tested in a lab.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Likely microbiological test results demonstrating the reduction or elimination of specific microorganisms. The document uses the general term "sanitized" which implies a measurable reduction in microbial load to a safe level, based on established public health standards for sanitization.