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The Absolute White Light is intended for use by the end consumer. The Absolute White Light is a battery operated, hand held device that contains a hun vosible light in the 400 nanometer spectrum, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. Built in safety features include automatic light shut off after two minutes and "Light Guard" that prevents light exposure to the user's eyes.

AI/ML Overview

The provided document describes the Absolute White Light, a device intended to provide a light source for bleaching teeth. However, it does not include a study that proves the device meets specific acceptance criteria in terms of efficacy or performance on human subjects for tooth whitening. Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety standards.

Here's a breakdown based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., a specific percentage improvement in tooth shade) for the Absolute White Light. Instead, it relies on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device (Dentovations Luster Whitening System) in terms of its intended use and technical characteristics.

The "performance data" section primarily refers to compliance with quality system regulations and safety standards, not clinical efficacy data.

Table of Comparison with Predicate Device (acting as the basis for "performance" as substantial equivalence):

Feature	Absolute White Light	Dentovations Luster Light (Predicate)	Acceptance Criteria Implied by Equivalence	Reported Device Performance (Absolute White Light)
Intended Use	Light source, Teeth Bleaching	Light source, Teeth Bleaching	Same as Predicate	Light source, Teeth Bleaching
Method of Use	Hand Held	Hand Held	Same as Predicate	Hand Held
Treatment Time	2 minutes	2 minutes	Same as Predicate	2 minutes
Treatment(s)	As Needed	As Needed	Same as Predicate	As Needed
Area of Use	Oral Cavity	Oral Cavity	Same as Predicate	Oral Cavity
Light Source	LED	LED	Same as Predicate	LED
Wavelength of Light	400 nm	350 – 700 nm	Within (or close to) Predicate's range	400 nm (within predicate range)
Color of Light	Blue	Blue	Same as Predicate	Blue
Presentation	Non-Sterile	Non-Sterile	Same as Predicate	Non-Sterile

Additional "Performance Data" (Compliance, not clinical efficacy):
The device is manufactured in compliance with:

Quality System Regulations (21 CFR 820)
DIN EN ISO13485:2003
DIN EN ISO 9001:2000
EN 61000-6-1 Electromagnetic compatibility (EMC) Part 6-1: Immunity standard for residential, commercial and light-industrial environments
EN61000-6-3 Electromagnetic compatibility (EMC) Part 6-3: Emission standard for residential, commercial and light-industrial environments

Study Details (or lack thereof)

Based on the provided text, there is no specific clinical study or performance study presented that directly proves the device's efficacy in terms of tooth whitening (e.g., changes in shade). The submission relies on demonstrating substantial equivalence to a predicate device, implying that since the predicate device is already cleared for use, a device with similar characteristics and intended use is also safe and effective.

Therefore, the following points cannot be addressed with the provided text, as no such study is described:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, no clinical test set described for efficacy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set described for efficacy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no clinical test set described for efficacy.
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 is not an AI/imaging diagnostic device. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an AI/imaging diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth for efficacy was established or reported. The "ground truth" for regulatory clearance was the substantial equivalence to the predicate device based on technical specifications and safety standards.
The sample size for the training set: Not applicable, no machine learning model or training set is described.
How the ground truth for the training set was established: Not applicable, no machine learning model or training set is described.

Conclusion from the document:

The regulatory approval (K110888) was granted based on the determination of "substantial equivalence" of the Absolute White Light to the predicate device (Dentify Luster Whitening System, K042153). This means the FDA concluded that the new device has the same intended use and similar technological characteristics to a device already on the market and does not raise different questions of safety and effectiveness. The "performance data" provided focuses on manufacturing quality systems and adherence to electromagnetic compatibility (EMC) standards, not on clinical performance demonstrating tooth whitening efficacy in human subjects.

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