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.

Device Description

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.

AI/ML Overview

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.

Summary

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510(k) Summary for Dentlight Oral Exam Light Kit

JUL 1 5 2010

1. APPLICANT

DentLight Inc. 1411 E. Campbell Rd., Suite 500 Richardson, TX 75081

Contact Person: Richard Liu Tel: 972-889-8857 Fax: 972-346-6550

Date Prepared: April 9, 2010

2. DEVICE NAME

Proprietary Name: Dentlight Oral Exam Light Kit Common/Usual Name: Oral Examination Light Classification Name: Ultraviolet Detector (872.6350)

3. PREDICATE DEVICES

Velscope (K070523) by LED Medical Diagnostics Sapphire O/E Oral Examination System by Den-Mat Holdings (K073483) Identafi 3000 (K090135) by Trimira, Remicalm

4. DEVICE DESCRIPTION

Dentlight Oral Exam Light Kit is a rechargeable-battery-powered cordless unit designed for if!umination 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.

5. INTENDED USE

Dentlight Oral Exam Light Kit is indicated for providing illumination to aid visualization during oral procedures and an adjunct to enhance the visualization for oral examination of mucosal abnormalities and oral lesions.

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6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANDTIAL EQUIVALENCE

Dentlight Oral Exam Light Kit is substantially equivalent to K070523, K073483, and K090135 in intended use and operation; each uses fluorescence and/or reflectance as the primary mode for enhanced visualization of tissue for determining oral tissue abnormalities.

Predicate K070523 uses 120V AC powered metal halide light to produce a single I redicate 1070522 about views fluorescence through a connected handpiece with a filtered lens.

Predicate K073483 uses 120V AC powered Xenon plasma arc light and filters to produce a single collimated blue light and views fluorescence through a connected handpiece with a filtered lens.

Predicate K090135 uses AA-battery-powered low power LED light to produce a r iour light at near site to tissue and view fluorescence through a broadband polarized filter glass. A selectable wavelength mechanism is built in with polarized white and amber LED lights that compliment fluorescence image.

Dentlight Oral Exam Light Kit offers two illumination modalities and one Dommon detection/viewing mechanism. Both illumination modalities use LED light source in multiple wavelength spectra as illumination or excitation source fight bour cuorescence/reflection. The operational principles of the proposed and rer ticate devices are identical with the primary mode for enhanced visualization of tissue through fluorescence. The operator chooses the appropriate wavelength light source to illuminate regions of oral cavity for inspection.

The major differences between the proposed Dentlight Oral Exam Light Kit and the predicate devices are the magnified high contrast filter used in the detection/viewing, the illumination intensity, size, weight and portability of the device. The increased light intensity of the proposed Dentlight Oral Exam Light detrioe. The moreason LED allows the illumination and excitation with improved clarity. The improved portability with cordless hands free operation or wand operation enables better, easier and faster exam procedures. The size and weight is a benefit to constant patient operations and counter space.

7. PERFORMANCE TESTING AND COMPLIANCE

The following testing was conducted to evaluate the functionality and performance of the proposed Dentlight Oral Exam Light Kit:

Optical Power Testing .
Optical wavelength .
Beam Quality .
Illumination and Fluorescence Image .

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The Dentlight Oral Exam Light Kit is designed to comply with electrical safety Inc Dentific Off. Blank Bigillity and will comply with electrical safety requirement established by IEC 60601-1-2.

We believe the similarity of the Dentlight Oral Exam Light Kit to the legally we believe the simmarity of the Deling... and the provided support the safety manketed productions of the Dentlight Oral Exam Light Kit for the indicated use.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Richard Liu President DentLight, Incorporated 1411 East Campbell Road, Suite 500 Richardson, Texas 75081

JUL 1 5 2010

Re: K101140

Trade/Device Name: DentLight Oral Exam Light Kit Regulation Number: 21 CFR 872.6350 Regulation Name: Ultraviolet Detector Regulatory Class: II Product Code: EAQ, NXV Dated: April 9, 2010 Received: April 22, 2010

Dear Dr. Liu

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent(for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, nowever, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Dr. Liu

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K101140

Device Name: Dentlight Oral Exam Light Kit

Indications For Use:

ਮ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ASBetz DDS for Dr. Susan Renner
Division Sign Off

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K101140

Regulation Number and Section

§ 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.