The provided document is a 510(k) clearance letter from the FDA for a dental curing light, the Ledex WL-070. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain the detailed information necessary to complete the requested table and answer the specific questions about acceptance criteria and a study design.

Here's why and what information is missing:

Substantial Equivalence (SE) vs. Performance Studies: The FDA's 510(k) clearance process for most devices (especially Class II) primarily relies on demonstrating "substantial equivalence" to a predicate device. This often involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. While performance data are usually submitted, the FDA letter itself generally does not detail the specific acceptance criteria, study methodologies, or the results in the comprehensive way you've requested for an AI/CADe type of device.
Device Type: The Ledex WL-070 is an "Ultraviolet Activator For Polymerization" (a dental curing light). This is a hardware device, not an AI/CADe (Computer-Aided Detection/Diagnosis) software. The questions you've posed (e.g., MRMC studies, human readers with/without AI assistance, training/test sets, ground truth establishment for AI) are highly specific to AI/CADe systems, which are designed to assist human interpretation or to perform standalone diagnostic tasks with learned algorithms. A dental curing light hardens dental materials, and its performance is typically evaluated by criteria like light intensity, wavelength, curing depth, and temperature, not by AI-specific metrics.

Therefore, I cannot populate the table or answer the questions with the provided document. The document confirms market clearance but does not delve into the specific study details for acceptance criteria and performance as would be relevant for an AI/CADe device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized eagle-like symbol with three curved lines forming the body and wings. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2008

Mr. Cheng-Feng Chou General Manager Dentmate Technology Company, Limited No. 80-1, Lane 160, Section 4, Sanhe Road Sanchung CHINA (TAIWAN) 241

Re: K082408

Trade/Device Name: Ledex WL-070 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: II Product Code: EBZ Dated: November 17, 2008 Received: November 17, 2008

Dear Mr. Chou:

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. Chou

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu S. Lin, Ph. D

Division 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

长682408 510(k) Number (if Know):

Trade/Device Name & Model Number: LEDEX WL-070

Indications for Use:

This LEDEX WL-070 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Susan Russo

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

510(k) Number: K050408

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.