The Avante LED curing light performs the same intended function as its predicate device, Versalux (reference K010133). Both devices are both used as a light activation system for dental restorative resins.

The physical features of the Avante LED curing light provide the dentist with a compact shape and cordless design to facilitate ease of use while using standard light emitting diode technology for optimum curing functions. The Avante LED curing light provides minimum output of 1.000 MW/cm2 which results in typical curing times of 10 seconds for most composite materials. Peak output is measured at 470nm. Curing time can be set between 1- 40 seconds for greater versatility in individual applications.

Accessories include the Avante light guides which are available in four diameters to accommodate dentist preference and use.

The effective portability of the Avante LED curing light is maintained through use of a charging light which is incorporated into the device stand. Included as well in the charging light is a radiometer display to verify proper light output. Lithium-ion batteries power the device and provide 45 minutes on average between charging times.

AI/ML Overview

This submission is for a medical device (Avante LED curing light), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for AI/ML performance is not applicable. The provided text describes the device's function, physical features, and substantial equivalence to a predicate device, but does not include information about clinical trials or performance metrics in a way that would directly translate to the requested AI/ML-specific criteria.

The submission focuses on establishing substantial equivalence to a legally marketed predicate device (Versalux, K010133) for its intended use as a light activation system for dental restorative resins.

However, I can extract the device's reported performance characteristics from the provided text:

Device Performance Information Extracted from the Text:

Characteristic	Reported Performance
Intended Function	Light activation system for dental restorative resins.
Minimum Output	1,000 mW/cm²
Typical Curing Times	10 seconds for most composite materials
Peak Output Wavelength	470nm
Adjustable Curing Time	1-40 seconds
Battery Life	45 minutes on average between charging times (using Lithium-ion batteries)
Additional Features	Compact shape, cordless design, radiometer display to verify proper light output, charging light incorporated into device stand, available with four diameters of light guides.

Since the request is about acceptance criteria and study that proves the device meets the acceptance criteria and the context is a 510(k) submission for a non-AI/ML medical device, the "study" demonstrating it meets acceptance criteria for this type of device is typically a device comparison/equivalence study rather than a clinical outcome study. The provided document states:

"The Avante LED curing light performs the same intended function as its predicate device, Versalux (reference K010133)."
"A review for safety and effectiveness was performed and found not to have been affected."
"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..."

This indicates that the device was deemed acceptable due to its substantial equivalence to a predicate device, rather than through a a trial with a defined test set, experts, and ground truth as would be relevant for an AI/ML device.

Therefore, for the specific questions related to AI/ML device validation:

A table of acceptance criteria and the reported device performance: See table above for device performance. Acceptance criteria for this type of device would generally relate to performance specifications (light output, wavelength, curing time range, battery life) and safety, largely demonstrated through engineering testing and comparison to the predicate. The document doesn't explicitly list "acceptance criteria" values against which performance is measured, but rather states the device's capabilities.
Sample size used for the test set and the data provenance: Not applicable for this type of device submission's "study."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device submission's "study."
Adjudication method: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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OCT 2 1 2005

K052349

6.0 510(K) SUMMARY

Accessories include the Avante light guides which are available in four diameters to accommodate dentist preference and use.

A review for safety and effectiveness was performed and found not to have been affected.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Public Health Service

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Greg Moreau Quality Systems Pentron Clinical Technologies 68-70 north Plains Industrial Road Wallingford, Connecticut 06492

Re: K052349

Trade/Device Name: AVANTE LED CURING UNIT, MODEL N44 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet activator for polymerization Regulatory Class: II Product Code: EBZ Dated: September 29, 2005 Received: October 3, 2005

Dear Mr. Moreau:

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. Moreau

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 (240) 276-0115. 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 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/industry/support/index.html.

Sincerely yours,

Srytie jr. Michael Omid.

Chiu Lin, Ph.D. 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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K052349

5.0 INDICATION FOR USE STATEMENT

510(k) NUMBER (IF KNOWN):

DEVICE NAME:

INDICATION FOR USE:

The Avante LED curing light is used as a light activation system for dental restorative resins.

(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)

Shoop Stirting (Civision Sign-Off) (Civision Sign-Off)
Division of Anesthesiology, General Hospital, Civision of Ancol, Dental Devices 16522349 510(k) Numbled(k) Submission for Avante LED

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.