The LED Turbo consists of a handy unit and a battery charger. The handy unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate, timing and monitoring the temperature of the LED.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "LED Turbo" dental curing light. This submission is for a medical device that cures dental resins and activates bleaching materials, not an AI/ML device, and therefore does not include the typical acceptance criteria and study designs associated with AI/ML device evaluations.

However, based on the information provided, I can construct a table comparing the device's performance against its predicate device, which serves as a form of "acceptance criteria" in the context of a 510(k) submission for substantial equivalence.

Here's an analysis based on the provided text, focusing on how a comparison-based "acceptance" is demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" for a new device are primarily its substantial equivalence to a legally marketed predicate device. This is demonstrated by comparing key technical specifications and functional performance. The table below presents the comparison found in the document.

Feature	Predicate Device (Ultra-Lite 200E Plus)	Proposed Device (LED Turbo)	"Acceptance Criteria" (Substantial Equivalence)
1. Light Intensity	Min. 800mW/cm²	1100mW/cm² (Min. 800mW/cm²)	Meets or exceeds predicate
2. Output Wavelength	440nm~490nm	440nm~490nm	Identical to predicate
3. LED Power Consumption	1 Watt	5 Watt	Different, but within functional parameters*
4. Battery Use	9.6V/300mAh	7.2V/1900mAh	Different, but within functional parameters*
5. Operating Voltage	AC110V, AC120V, AC230, 50/60Hz	AC100V~260V 50/60Hz	Compatible with broader range than predicate
6. Weight	380 g	(Not explicitly stated for LED Turbo)	Not directly comparable from text
7. Curing Time	20 seconds	5, 10, 20, 40 seconds selectable	Offers more options, includes predicate's time
Intended Use	Dental curing light for polymerization of dental resins and activation of bleaching materials	Dental curing light for polymerization of dental resins and activation of bleaching materials	Identical
Operational Principles	Identical	Identical	Identical

*Interpretation: The differences in LED power consumption and battery use are presented as technical differences that still achieve equivalent or improved performance (e.g., higher intensity, shorter curing times) while maintaining safety through "Performance testing ... that confirms that the halogen light technology used for LED Turbo is able to cure resin and activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue." This "performance testing" is the closest equivalent to a direct study proving criteria.

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

The document does not describe a traditional "test set" in the context of an AI/ML device where a dataset is analyzed by the algorithm. Instead, it refers to "Performance testing."

Sample Size: Not specified. The document states "Performance testing has been conducted," but the number of resins, bleaching materials, or in-vitro/in-vivo tests is not provided.
Data Provenance: Not specified. The text doesn't explicitly state the country of origin of the test data or whether it was retrospective or prospective.

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 to this 510(k) submission. Dental curing lights are physical devices that cure materials; they do not involve human expert interpretation for establishing ground truth in the way AI/ML devices for image analysis do. The "truth" is based on physical material properties and established dental clinical efficacy.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as would be used for expert review of data for AI/ML validation.

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 is not an AI/ML device and therefore no MRMC study involving human readers with or without AI assistance would have been conducted or reported.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (dental curing light), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for a dental curing light relates to its ability to effectively cure dental resins and activate bleaching agents without causing harm. The document states that "Performance testing has been conducted that confirms that the halogen light technology used for LED Turbo is able to cure resin and activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue."

Therefore, the type of "ground truth" would likely be physical measurements and material science validation (e.g., degree of conversion of resin, color change in bleaching agents, temperature measurements to detect thermal damage).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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8. PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR CURING LIGHT LED TURBO

MAR 2 5 2004

8.1 Submitter's name: APOZA ENTERPRISE CO., LTD.

K040618

8.2 Address: 6F, 657, Chung-Cheng Road, Hsin-Chuang City, 242 Taipei Hsien, Taiwan, ROC.

8.3 Phone No:886-2-29010620
8.4 Fax No:886-2-29012208
8.5 Contact person: Mr. Shin Min Teh
8.6 Date prepare: Feb 1, 2004
8.7 Trade name/proprietary name: LED Turbo
8.8 Common name/usual name: Dental Curing Light

8.9 Classification name: Ultraviolet dental curing light.

TRADE NAME	COMMON NAME	CLASSIFICATION NAME
LED Turbo	Dental curing light	Ultraviolet activator forpolymerization

8.10 Legally market device equivalence:

Ultra-Lite 200E Plus 510k number: K023545 Manufacturer: Rolence Enterprise, Inc.

8.11 Intended use:

The LED Turbo is a dental curing light that is designed for use in the optic polymerization of dental resins and activation of bleaching materials.

8.12 Device description

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	LED Turbo	Ultra-Lite 200E Plus
1. Light Intensity	1100mW/cm2 (Min.800mW/cm2)	Min. 800mW/cm2
2. Output Wave length	440nm~490nm	440nm~490nm
3. LED power consumption	5Watt	1 Watt
4. battery use	7.2V/1900mAh	9.6V/300mAh
5. Operating Voltage	AC100V~260V 50/60Hz	AC110V, AC120V, AC230, 50/60Hz
6.Weight		380 g
7.Curing time	5, 10, 20, 40 seconds selectable	20 seconds

8.14 Comparison with equivalence marketed device:

Both the LED Turbo and the predicate curing lights offer multiple curing programs for photopolymerization of dental resins and activation of bleaching materials. These programs differ in the intensity of the light delivered and the length of the light exposure. The operational principles of the proposed and predicate devices are identical. The operator chooses the appropriate program and sets the treatment parameters, if necessary. The tip of handpiece if oriented appropriately relative to the material being photopolymerized, or the tooth surface (for bleaching procedures), and the selected treatment is initiated.

The major difference between the proposed LED Turbo Gun and the predicate curing lights is the intensity of the light power delivered. The increased light intensity of the proposed LED Turbo allows the resin curing and tooth whitening agent activation to be conducted in a much shorter timeframe. Performance testing has been conducted that confirms that the halogen light technology used for LED Turbo is able to cure resin and activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue.

The Similarities in intended use, technical specifications, and functional performance between the LED Turbo and Ultra-Lite 200e Plus leads to a conclusion of substantial equivalence between the proposed and predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2004

Mr. Shih Min-Teh General Manager Apoza Enterprise Company, LTD 6F, 657, Chung-Cheng Road Hsin-Chuang City, Taipei Hsien, 242 Taiwan, CHINA

Re: K040618

Trade/Device Name: LED Turbo Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ and EEG Dated: February 01, 2004 Received: March 10, 2004

Dear Mr. Min-Teh:

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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Page 2 – Mr. Shih Min-Teh

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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 vours,

Carls

Chiu S. Lin, PhD 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): K040618

Device Name: LED Turbo

Indications for Use:

The LED Turbo is a dental curing light that is designed for use in the polymerization of dental resins and the activation of bleaching materials.

Prescription Use
(21 CFR Part 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Ruong

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

1-12/11, 510(k) Number:

Page 1 of __ 1___

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.