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BriteWhite Teeth Whitening System is intended to emit light in the 400 nanometer spectrum to provide a light source for the bleaching of teeth.

The BriteWhite Teeth Whitening System device that utilizes Light Emitting Diodes to provide a tooth whitening system, the whitening light source is a mouth piece which is placed inside the mouth, using barrier sleeves, which emits a biologically safe and effective level of blue visible light. The general wavelength for the mouth piece is 400 nanometer spectrums to provide a selected wavelength which activates the whitening gel to bleach the teeth without the aide of heat. To ensure user safety when operating the light, the system has a built in feature to eliminate any risk for the end user and professional. The light automatically shuts off after a specified period of time. Secondly, the light source in placed inside the mouth, so there is no need for safety glasses for the patient and professional. No contact with the eyes is in this area of treatment and prevents penetrations of blue wavelength and protects the vision of the patient and professional.

The provided text is related to a 510(k) submission for the BriteWhite Teeth Whitening System. This document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with specific acceptance criteria and performance data in the format of a clinical trial or performance study.

Therefore, many of the requested elements regarding acceptance criteria, study design, sample size, expert ground truth, and comparative effectiveness are not available in this type of regulatory document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., a certain percentage improvement in tooth shade) or comparative performance data (e.g., measured whitening effectiveness). The clearance is based on substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. The document does not describe a test set used for performance validation in a clinical study format. The clearance is based on comparison to predicate devices' established safety and effectiveness.
• Data Provenance: Not applicable. No specific performance data from a new study is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no mention of a test set with expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable. No test set requiring expert adjudication is described.

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:

• Not applicable. This device is a tooth whitening system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical medical device (light source), not a software algorithm.

7. The type of ground truth used:

• Not applicable in the context of a performance study. The "ground truth" for regulatory clearance is the established performance and safety of the predicate devices. The claim of "substantial equivalence" implies that the new device meets the same standards as the legally marketed predicates.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or a training set.

9. How the ground truth for the training set was established:

• Not applicable. This device does not involve machine learning or a training set.

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