(84 days)
Dentlight Oral Exam Light Kit is indicated to be used by a dentist and physician for illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.
Dentlight Oral Exam Light Kit is a rechargeable-battery-powered cordless unit designed for illumination and examination for dental and physician's office on any procedures which require a small homogenous and well-defined spot and natural tissue reflectance and fluorescence visualization of healthy and abnormal tissue.
Dentlight Oral Exam Light Kit consists of a cordless unit with interchangeable light head (White and Violet), custom adaptable Fluorescence Loupe Filters and Filter Caps, Charging Stand, Power Adapter, and Patient Protective Eyewear Goggle.
This document is a 510(k) summary for the Dentlight Oral Exam Light Kit. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with acceptance criteria in the way a clinical trial for an AI diagnostic device would.
Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or diagnostic tools, is not present in this document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided text. The document refers to "Performance Testing and Compliance" but does not define specific acceptance criteria or report quantitative results against them. The testing listed is:
- Optical Power Testing
- Optical wavelength
- Beam Quality
- Illumination and Fluorescence Image
The document states, "The Dentlight Oral Exam Light Kit is designed to comply with electrical safety... and will comply with electrical safety requirement established by IEC 60601-1-2." This is a compliance statement rather than a performance acceptance criterion.
2. Sample size used for the test set and the data provenance
This information is not provided. As this is a submission for a physical medical device (an examination light) rather than a diagnostic algorithm, the concept of a "test set" in the context of data for an algorithm is not applicable. The performance testing mentioned (optical power, wavelength, beam quality, illumination, and fluorescence image) would have been conducted on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided. The device is an illumination tool to aid visualization, not a diagnostic tool that produces a "result" needing ground truth establishment by experts in a study context. Its intended use is to "enhance the visualization for oral examination of mucosal abnormalities and oral lesions," meaning human clinicians still interpret the visual information.
4. Adjudication method for the test set
This information is not applicable/not provided.
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
This information is not applicable/not provided. The device is not an AI system. While a clinical study could be performed to assess if the device improves human visualization and diagnosis, this document does not present such a study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/not provided.
8. The sample size for the training set
This information is not applicable/not provided. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. This is not an AI algorithm requiring a training set.
Summary of what the document does provide regarding performance and equivalence:
- Device Type: The Dentlight Oral Exam Light Kit is a rechargeable, cordless unit for illumination and enhanced visualization of oral tissue abnormalities using fluorescence and/or reflectance.
- Intended Use: To provide illumination to aid visualization during oral procedures and as an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.
- Substantial Equivalence Claim: The device is claimed to be substantially equivalent to three predicate devices (Velscope K070523, Sapphire O/E K073483, Identafi 3000 K090135) in intended use and operation. All use fluorescence and/or reflectance for enhanced tissue visualization.
- Technological Characteristics Comparison:
- Predicate K070523: 120V AC powered metal halide light, views fluorescence via filtered lens.
- Predicate K073483: 120V AC powered Xenon plasma arc light, views fluorescence via filtered lens.
- Predicate K090135: AA-battery-powered low power LED, views fluorescence through a broadband polarized filter glass, selectable wavelength (polarized white and amber LED).
- Proposed Device: Uses LED light source in multiple wavelength spectra for illumination/excitation, offers two illumination modalities and one common detection/viewing mechanism.
- Claimed Advantages of Proposed Device: Magnified high contrast filter for detection/viewing, increased light intensity from "new reason LED" for improved clarity, improved portability with cordless hands-free or wand operation, benefits in size and weight for patient operations and counter space.
- Performance Testing Listed: Optical Power Testing, Optical wavelength, Beam Quality, Illumination and Fluorescence Image. (No results or acceptance criteria are given).
- Compliance: Designed to comply with electrical safety requirements established by IEC 60601-1-2.
In essence, this 510(k) submission relies on demonstrating that the Dentlight Oral Exam Light Kit has similar technological characteristics and the same intended use as already-marketed (predicate) devices, supported by general performance testing and electrical safety compliance, rather than proving a specific diagnostic accuracy against defined criteria in a clinical study as would be expected for a novel AI diagnostic device.
§ 872.6350 Ultraviolet detector.
(a)
Identification. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.(b)
Classification. Class II.