The Toesco Aqua Blue Led Light Curing Device is a gun-handle shaped dental curing light that is intended to polymerize dental materials such as resins and sealants by transmitting light through a light guiding tip. The source of blue light is a light-emitting diode. The device has two optional curing modes: two full power modes and a 2-step curing mode. It incorporates three pre-set programs and seven user programs. The power source is a 7.4 V Lithium Ion Battery. Wavelength is 450 nm - 480 nm, with wavelength peaking at 470nm.

AI/ML Overview

The provided text describes the Toesco Aqua Blue LED Light Curing Device, its intended use, and its comparison to a predicate device for 510(k) clearance. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes, or expert adjudication.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results against acceptance criteria.

Here's a breakdown based on the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states "non-clinical testing (bench testing) demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness," and lists several standards (IEC 60601-1-1, IEC 60601-1-2, Battery and Charger Testing, Environmental Testing, Reliability Testing) that were performed. However, it does not provide specific acceptance criteria values or the measured performance results for the Toesco Aqua Blue LED Light Curing Device against these criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/Not available. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical studies with a test set were conducted or required for this 510(k) submission. The non-clinical tests would have used specific test samples, but the number and nature of these test samples are not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable/Not available. As no clinical tests were performed, there was no test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable/Not available. As no clinical tests were performed, there was no test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a hardware product (a dental curing light), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

Not applicable/Not available. As no clinical tests were performed, there was no ground truth to establish in the context of device performance in a clinical setting. The "ground truth" for the non-clinical tests would be the established engineering standards and specifications for electrical safety, battery performance, environmental robustness, and reliability.

8. The Sample Size for the Training Set

Not applicable. This device does not involve AI or machine learning, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device does not involve AI or machine learning, so there is no "training set" or ground truth for it.

In summary, the provided document is a 510(k) submission for a non-AI dental device. The core of this submission relies on demonstrating substantial equivalence through non-clinical (bench) testing against a predicate device, rather than through clinical studies with defined acceptance criteria, ground truth, or expert evaluations.

Summary

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MAY 3 0 2002

KQ21374

EXHIBIT #1

510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:

1. Submitter's Identification:

Toei Electric Co., Ltd. 771, Shimosakunobe, Takatsu-ku Kawasaki-shi, Kanagawa-Ken 213-0033 Japan

Date Summary Prepared: April 29, 2002

Mr. Kazuhiro Tachibana Contact Person: Overseas Sales Marketing Manager

3. Name of the Device:

Toesco Aqua Blue LED Light Curing Device

3. Predicate Device Information:

K# 002925, CoolBlu Curing Light, Dental System.com, Inc., Heathrow, Florida

4. Device Description:

Intended Use: 5.

The Toesco Aqua Blue LED Light Curing Device is intended to provide visible light irradiation for the curing of dental VLC resin products.

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Comparison to Predicate Devices: દ.

Both the subject and predicate devices use an LED light source, but of differing light intensities (subject device is 330mW/cm² and predicate device is 320mW/cm², and a battery power source (subject device uses lithium ion battery, 7 .4V and predicate device uses Nickel Cadmium battery - power consumption for subject device is 23VA, and predicate device is 18VA). The respective configurations of the two devices show no major differences, and, are substantially equivalent in intended use and design.

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:

IEC 60601-1-1, IEC 60601-1-2, Battery and Charger Testing, Environmental Testing, Reliability Testing.

Discussion of Clinical Tests Performed: 8.

Not Applicable

9. Conclusions:

The Toesco Aqua Blue LED Light Curing Device has the same intended use and similar characteristics as the CoolBlu Curing Light Device. Moreover, non-clinical testing (bench testing) demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Toesco Aqua Blue LED Light Curing Device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Toei Electric Company Limited C/O Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

MAY 3 0 2002

Re: K021374

Trade/Device Name: Toesco Aqua Blue LED Light Curing Device Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: April 29, 2002 Received: May 01, 2002

Dear Ms. Goldstein-Falk :

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I tease of actived that I Drimination that your device complies with other requirements of the Act that I DA has made a acterimentations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Act 3 requirements) and manufacturing practice requirements as set CI K Part 6077; Mooning (21 CFR Part 820); and if applicable, the electronic forth in also qualis) 35 receives (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse FDA finding of substantial equivalence of your device to a legally premated noticated.com " results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OFF Carol (3. Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 + t the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oinor gonetar mionination turers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Paltrow Cucinotta

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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: Exhibit B

of Page

K021374

510(k) Number (if known):

Device Name: Toesco Aqua Blue LED Light Curing Device

Indications For Use:

The Toesco Aqua Blue LED Light Curing Device is intended to provide visible light irradiation for the curing of dental VLC resin products.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Susa Prome

(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Deyicqosing 1 510(k) Number -

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.