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REACH® Antibacterial Toothbrush is used to remove adherent plaque and food debris from teeth to reduce tooth decay. This device is made of a shaft (handle) with synthetic bristles attached at one end. An antibacterial agent has been added to the handle portion. The antibacterial activity is limited to the handle of the toothbrush.

Device Description

Both the modified device and the predicate device are manual toothbrushes consisting of a shaft with synthetic bristles at one end. Antibacterial agents have been incorporated into the devices.

AI/ML Overview

The acceptance criteria and study proving the device meets them are summarized below:

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Study	Acceptance Criteria (Implicit)	Reported Device Performance
Microbiology Study - Zone of Inhibition Test	The "plastic" portion of the toothbrush with antibacterial agent should be effective in inhibiting the growth of bacteria.	The "plastic" portion of the toothbrush with antibacterial agent added was effective in inhibiting the growth of most of the bacteria tested.
Analytical Study - Extraction Study Using HPLC	No detectable antibacterial agent should leach out into a toothpaste/water slurry after 6 hours of simulated brushing, nor into an alcohol/water solution after 24 hours of soaking. (Limit of quantitation = 1 ppm)	HPLC results showed no detectable antibacterial agent in either the toothpaste/water slurry or the alcohol/water solution (limit of quantitation of antibacterial agent = 1 ppm).
Mucous Membrane Irritation - Hamster Cheek	The toothbrush with added antibacterial agent should not cause a significant difference in degree of irritation compared to toothbrushes without antibacterial agent when in contact with oral mucosal tissue.	Results showed no significant difference in degree of irritation between toothbrushes with antibacterial agent and toothbrushes without antibacterial agent.
In vitro Cytotoxicity Study - USP Agar Diffusion	No evidence of cell lysis or toxicity should be observed for the toothbrush with antibacterial agent added.	Results showed no evidence of cell lysis or toxicity for either the toothbrushes with an added antibacterial agent or the toothbrushes without an added antibacterial agent.

2. Sample Size and Data Provenance:

Test Set Sample Sizes:
- Microbiology Study: "several different strains of bacteria" were exposed. The exact number of strains or individual samples is not specified.
- Analytical Study: Not explicitly stated, but implies a sufficient number of samples were run for the HPLC analysis of the two solutions (toothpaste/water slurry and alcohol/water solution).
- Mucous Membrane Irritation: Implies a comparison between "toothbrushes with antibacterial agent" and "toothbrushes without antibacterial agent" in hamster cheek pouches. The specific number of hamsters or toothbrushes is not provided.
- In vitro Cytotoxicity Study: Implies a comparison between "toothbrushes with an added antibacterial agent" and "toothbrushes without an added antibacterial agent" as tested on mammalian cell cultures. The specific number of cell cultures or toothbrush samples is not provided.
Data Provenance: Not explicitly stated, but given Johnson & Johnson Consumer Franchises Worldwide is the submitter and the reports are part of a 510(k) submission, the studies were likely conducted internally or by contract research organizations within the United States. The studies are prospective in nature, designed to evaluate the safety and performance of the modified device.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable as the reported studies are laboratory and preclinical tests, not analyses requiring expert human interpretation of medical images or data. The "ground truth" for these tests comes from the scientific methods themselves (e.g., inhibition zones, HPLC readings, irritation scores, cytotoxicity assays).

4. Adjudication Method:

Not applicable for these types of laboratory and preclinical studies.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a toothbrush, not a diagnostic device involving human readers of medical cases.

6. Standalone Performance Study:

Yes, all the described studies (Microbiology Study, Analytical Study, Mucous Membrane Irritation, and In vitro Cytotoxicity Study) are standalone evaluations of the device's characteristics and performance. They assess the device itself against scientific benchmarks and comparisons to a non-antibacterial version, without human-in-the-loop performance measurement.

7. Type of Ground Truth Used:

The ground truth used for these studies is based on objective scientific measurements and established laboratory protocols:
- Microbiology: Direct observation of bacterial growth inhibition (Zone of Inhibition).
- Analytical: Quantitative chemical analysis using High-Performance Liquid Chromatography (HPLC) to detect specific compounds.
- Mucous Membrane Irritation: Histopathological or macroscopic assessment of tissue irritation in a preclinical model.
- In vitro Cytotoxicity: Observation of cell lysis and viability in mammalian cell cultures following USP guidelines.

8. Sample Size for the Training Set:

Not applicable. These are verification and validation studies (test sets) for a physical device, not an AI/machine learning model that requires a "training set."

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

Not applicable, as there is no training set for an AI/machine learning model in this context.

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