The LED Turbo-Pen 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 is a 510(k) Premarket Notification summary for the LED Turbo-Pen dental curing light. While it describes the device, its intended use, and compares it to a legally marketed predicate device, it does not contain information about a specific study designed to prove the device meets acceptance criteria.

The section titled "Performance testing has been conducted..." indicates that some testing was performed, but it lacks the detailed methodology, acceptance criteria, results, and other specifics typically found in a study report. The document primarily focuses on establishing substantial equivalence to a predicate device based on technical specifications and intended use.

Therefore, many of the requested elements for describing the acceptance criteria and a study proving compliance cannot be fully answered from this document.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for a study in the format usually requested. However, it does imply performance expectations by comparing the LED Turbo-Pen's specifications to its predicate device, the LED Turbo. The "reported device performance" is essentially the device's measured specifications.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (LED Turbo-Pen)
Light Intensity	1600 mW/cm²	500~1600 mW/cm²
Output Wavelength	440nm~490nm	440nm~490nm
LED Power Consumption	5 Watt	1 Watt and 5 Watt
Battery Use	7.2V/1900mAh	7.2V/1900mAh
Operating Voltage	AC100V~260V 50/60Hz	AC100V~260V 50/60Hz
Curing Time	5, 10, 20, 40 seconds selectable	5, 10, 20, 40 seconds selectable

Note: The "acceptance criteria" here are implied by the specifications of the predicate device (LED Turbo) which the LED Turbo-Pen is claiming substantial equivalence to.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document mentions "Performance testing has been conducted" but provides no details on the number of devices or materials tested.
Data Provenance: Not specified. It does not mention the country of origin of the 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 (e.g. radiologist with 10 years of experience)

Not specified. The document does not describe a study involving expert assessment for establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified. There is no mention of any adjudication method.

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 device is a dental curing light, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant to this device's function.

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

This question is generally relevant for AI/software devices. For a dental curing light, its "standalone performance" is its ability to cure resin and activate bleaching agents effectively, which is alluded to but not detailed as a standalone study in the provided text. The document states: "Performance testing has been conducted that confirms that the halogen light technology used for LED Turbo-Pen is able to cure resin and activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue." However, no study details are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a dental curing light, "ground truth" would typically relate to objective measures like the degree of polymerization of dental resins or the efficacy of bleaching material activation, and the absence of thermal damage. The document mentions confirming these aspects but does not describe the specific ground truth measures or how they were established.

8. The sample size for the training set

Not applicable. This device is a hardware product, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary

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8. PREMARKET NOTIFICATION 510(k) SUMMARY

OF SAFETY AND EFFECTIVENESS FOR

CURING LIGHT LED Turbo-Pen

(family: LED Turbo-Pen, TOP Light, TOP Light PLUS, KO4 1303

TOP Light Turbo) JUN 1 8 2004

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

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: Apr 1, 2004
8.7 Trade name/proprietary name: LED Turbo-Pen

(family: LED Turbo-Pen, TOP Light, TOP Light PLUS, TOP Light 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-Pen(family: LED Turbo-Pen,TOP Light, TOP LightPLUS, TOP Light Turbo)	Dental curing light	Ultraviolet activator forpolymerization

8.10 Legally market device equivalence:

Device name: Led Turbo 510k number: K040618 Manufacturer: APOZA Enterprise, Co,.Ltd.

8.11 Intended use:

The LED Turbo-Pen is a dental curing light that is designed for use in the optic polymerization of dental resins.

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8.12 Device description

	LED Turbo-Pen	Led Turbo
1. Light Intensity	500~1600mW/cm²	1600mW/cm²
2. Output Wavelength	440nm~490nm	440nm~490nm
3. LED powerconsumption	1 Watt and 5Watt	5 Watt
4. Battery use	7.2V/1900mAh	7.2V/1900mAh
5. Operating Voltage	AC100V~260V 50/60Hz	AC100V~260V 50/60Hz
6. Curing time	5, 10, 20, 40 seconds selectable	5, 10, 20, 40 seconds selectable

8.14 Comparison with equivalence marketed device:

Both the LED Turbo-Pen 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-Pen and the predicate curing lights is the intensity of the light power delivered. The increased light intensity of the proposed LED Turbo-Pen 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-Pen 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-Pen and LED Turbo 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 2004

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

Re: K041303

Trade/Device Name: LED Turbo-Pen Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: May 01, 2004 Received: May 17, 2004

Dear Mr. Min-Teh:

We have reviewed your Section 510(k) premarket notification of intent to market the device in indicati we nave revewed your Section 910(R) premained houbstantially equivalent (for the indications for referenced above and have decemined the essee predicate devices marketed in interstate winest the t use stated in the encreative to regarly manolical Device Amendments, or to devices that prior to May 26, 1770, the chaemient with the provisions of the Federal Food, Drug, and Cosmetic have been reclassified in accordance will at a proval application (PMA). You may, Act (Act) that do not require approval or a provisions of the Act. The Act. The eeneral therefore, market the device, subject to the general for annual registration, listing of devices, good Controls provisions of the necessary and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see ao re) into existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Seconderning 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 Please be advised that FDA S Issualice of a successfiel with other requirements of the Act of that FDA has made a deletinination that your are room Federal agencies. You must comply with any Federal statures and regulations administered of to: registration ond listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: rest set forth all the Act s requirements, but not rime in the requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturer in the colors and until sediation labeling (21 CFR Part 801), good manazating production, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product systems (QB) regalaxes (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 his letter will anow you to ocgin marketing of substantial equivalence of your device to a legally premarket nothleation. The PDA miding of backannal or some of this, 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
s the promotion of the 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 1 if you desire specific advice for your device on on and time of the promotions on the promotion contact the Office of Compliance at (301) 594-4039 Compliance at (301) 594-4639. Also, Sales (131 CED and advertising of your device, prease corract in 5 oreference to premarket notification under the Ast ma please note the regulation entitled, "Misoralians" of responsibilities under the Act may Part 807,97) you may obtain. Other general informational and Consumer Assistance at its be obtained from the DFABICS or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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): K041303

Device Name: LED Turbo-Pen Indications for Use:

The LED Turbo-Pen is a dental curing light that is designed for use in the optical polymerization of dental resins.

Prescription Use J × (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)

Susan Ruane

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

510(k) Number:_

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.