(91 days)
The Dentovations South Beach Smile Light Whitening System is intended for use as a light source for bleaching teeth.
The South Beach Smile Light Whitening System is intended for use by the consumer and sold either over the counter or by a dental professional as a yooth whitening system. The System consists of a handheld, battery operated light theat source) device, a whitening gel and preconditioning mouth wash. The Whitening Light heat source is a hand held device that contains a biologically safe and effective level of blue visible light, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. The general wavelength is 350 -700 nm. The xenon light emits approximately 1 - 3 ° C heat agginst the tooth surface. To insure user safety when operating the light, the light has built in features that will eliminate any risk for the end user (1) light automatically shuts off after two minutes of use and (2) the light head acts a light automatouny shuts on and light from accidentally being exposed to the users eyes.
The provided text is a 510(k) Premarket Notification Summary for the "South Beach Smile Light Whitening System." It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance data from a specific study with acceptance criteria.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted because such a study is not presented in the provided document. The document describes the device, its intended use, and compares its technical characteristics to predicate devices. It states that the device has been tested and proven to be safe for the consumer to use, but it does not detail the specific tests, acceptance criteria, or their results in a quantitative manner as requested.
Here's an attempt to answer based on the available information, with many points noted as "Not provided in the text":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| Minimal heat generation | Emits approximately 1 - 3 °C heat against the tooth surface. |
| Automatic shut-off | Automatically shuts off after two minutes of use. |
| Light head shields eyes | Light head acts as a shield to prevent light from accidentally being exposed to the user's eyes. |
| Biologically safe light level | Contains a biologically safe and effective level of blue visible light. |
| Functional/Technological Characteristics: | |
| Light wavelength | Emits light in the 350 - 700 nanometer spectrums. General wavelength: 350 - 700 nm. |
| Intended Use | Intended to emit light in the 350 - 700 nanometer spectrums to provide a heat source for bleaching of teeth. Performs as intended. |
| Substantial equivalence to predicate device | Has the same intended use, with similar functional and performance characteristics to predicate devices (BriteSmile and Dental ZOOM Light). |
2. Sample size used for the test set and the data provenance
Not provided in the text. The document states "The Whitening Light has been tested and proven to be safe for the consumer to use," but no details on the sample size or provenance of this testing are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes device characteristics and safety features, not a diagnostic or classification task requiring expert ground truth for a test set.
4. Adjudication method for the test set
Not applicable, as no test set requiring ground truth 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 light source for tooth whitening, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not relevant to the described device, which is a physical light system. The closest equivalent is the device's inherent performance characteristics as described in point 1.
7. The type of ground truth used
Not applicable. The "ground truth" for the device's performance relates to its physical output (e.g., light wavelength, heat generation) and safety features, which would be measured against engineering specifications or known safety standards, not an expert-derived ground truth or pathology.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would involve a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device that would involve a training set.
§ 872.6475 Heat source for bleaching teeth.
(a)
Identification. A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.