Valo® Cordless is a visible light activator for polymerization of dental resins. In other words, it is a dental curing light used for polymerization of all photo-initiated dental materials. The VALO Cordless is shipped as a system with the VALO Cordless wand, 4 rechargeable batteries, 2 for initial use and 2 for later use, a battery charger and 50 VALO Cordless Barrier Sleeves. An Instruction for Use is also included inside the packaging. The Instructions for Use details the function of the device and describes the modes for the VALO Cordless. VALO Cordless has three operating modes. They are Standard Power Mode: 1000mW/cm², High Power Mode: 1400mW/cm² and Xtra Power Mode: 3200mW/cm².

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the VALO® Cordless device. It's important to note that this document is a 510(k) premarket summary for a dental curing light, not an AI/ML device. Therefore, several sections of your request related to AI/ML specific criteria (like MRMC studies, training set details, or number of experts for ground truth) will not be applicable.

Acceptance Criteria and Device Performance for VALO® Cordless

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Characteristic	VALO® Cordless Performance (Reported)
Wavelength Range	395nm – 480nm (Effective output Power)
	Minimal power: 380nm – 395nm and 480nm – 510nm
	Complies with ADA 48 specifications for power limitations within specific wavelength bands.
Light Intensity (Power Modes)	Standard Power Mode: ~1000 mW/cm² +/- 10%
	High Power Mode: ~1400 mW/cm² +/- 10%
	Xtra Power Mode: ~3200 mW/cm² +/- 20% (formerly 'Plasma Emulation')
Power Supply	Same as predicate (wall powered, 12VDC, medical grade with adapters for International capability, UL Approved) - Note: The descriptor "Cordless" implies rechargeable batteries are the primary power supply for operation, while the "Power Supply" row likely refers to the charging unit's input.
Indications For Use	Source of illumination for curing photo-activated dental restorative materials and adhesives. (Same as predicate)
Structure	Ergonomic wand (Same as predicate)
Light	Blue and UV wavelengths (Same as predicate)
Current Control	Regulates current in the light source (Same as predicate)
Buttons	Two buttons that function the light (Same as predicate)
Power ON button	Located on handle of wand (Same as predicate)
Power cord	8' length (Same as predicate) - Again, likely refers to the charger.
Time	Device indicates time and time selection (Same as predicate)
Operation	110VAC (Same as predicate) - Refers to the charger's input.

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

The document does not explicitly state the sample size for individual tests like depth of cure or software verification. The "Performance Data" section discusses general instrument specifications (wavelength, intensity) and refers to "bench tests."

Sample Size: Not explicitly stated for specific tests.
Data Provenance: The tests were "conducted along with bench tests described in the 510(k)." This suggests the data is prospective and generated by Ultradent Products, Inc. (the applicant) as part of their device development and submission process. The country of origin of the data is implicitly the USA, where Ultradent Products, Inc. is located.

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

This information is not applicable as the VALO® Cordless is a physical medical device (dental curing light), not an AI/ML diagnostic or image analysis device that relies on expert interpretation for ground truth. The "ground truth" here refers to the physical and functional performance characteristics of the light itself, measured by instruments.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. Adjudication methods are typically used when human interpretation (e.g., of images) is involved in establishing ground truth, which is not the case for this type of device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human readers' performance with and without AI assistance is being evaluated. The VALO® Cordless is a standalone physical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance data presented (wavelength, light intensity, depth of cure, etc.) represents the standalone performance of the VALO® Cordless device itself, without human-in-the-loop considerations in the measurements of its physical properties. However, it's not "algorithm only" as it's a hardware device. The "software verification and validation" would assess the standalone performance of its internal control software.

7. The Type of Ground Truth Used

The ground truth used for verifying the device's performance is based on instrumental measurements and established physical/electrical safety standards.

Wavelength and Light Intensity: Measured by instruments like a Demetron® L.E.D. Radiometer and a spectrum analyzer. Compliance with ADA 48 standards (for wavelength bands) is also a form of established ground truth.
Depth of Cure: This would be measured using standardized laboratory procedures to determine how effectively the light cures dental materials.
Software Verification and Validation: This process establishes that the software performs as designed according to its specifications, which form the ground truth.
IEC 60601-1 Electrical Safety: Adherence to this international standard for medical electrical equipment forms a critical part of the safety ground truth.

8. The Sample Size for the Training Set

This is not applicable. The VALO® Cordless is a physical device; it does not utilize a "training set" in the context of machine learning.

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

This is not applicable as there is no training set for this device.

Summary

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SPECIAL 510(K) PREMARKET SUMMARY

VALO® Cordless

This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for VALO® Cordless.

Applicant's Name and Address

Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095

Contact Person: Title: Telephone: FAX: Date Summary Prepared:

Diane Rogers Regulatory Affairs Manager 800-552-5512 x4491, 801-553-4491 801-553-4609 April 1, 2011

Name of the Device

Trade Name:	VALO® Cordless
Common Name:	Activator, ultraviolet for polymerization
Device Classification:	II
Classification Product Code:	EBZ

Legally Marketed Predicate Device to Which Equivalence is Claimed

The predicate device is VALO® {K083647}. This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095.

Product Description: Valo® Cordless is a visible light activator for polymerization of dental resins. In other words, it is a dental curing light used for polymerization of all photo-initiated dental materials. The VALO Cordless is shipped as a system with the VALO Cordless wand, 4 rechargeable batteries, 2 for initial use and 2 for later use, a battery charger and 50 VALO Cordless Barrier Sleeves. An Instruction for Use is also included inside the packaging. The Instructions for Use details the function of the device and describes the modes for the VALO Cordless. VALO Cordless has three operating modes. They are Standard Power Mode: 1000mW/cm², High Power Mode: 1400mW/cm² and Xtra Power Mode: 3200mW/cm².

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110582

Source of illumination for curing photo-activated dental restorative Indications for Use: materials and adhesives.

Technological Summary: The VALO CORDLESS curing light uses a custom, multi-wavelength Light Emitting Diode (LED) for producing the high intensity light (395 - 480 nm) capable of polymerizing all light cure dental materials. This intensity will also penetrate porcelain and is capable of curing underlying resin cements similarly to a quality halogen light.

The VALO CORDLESS curing light uses safe Ultradent VALO rechargeable batteries and battery charger.

VALO CORDLESS Curing Light
Wavelength range	395nm – 480nm (see qualification below)
	Effective output Power of VALO CORDLESS falls within the following wavelength range:395nm <= EP <= 480nm.
	Minimal and insignificant power can be found in wavelength ranges from:380nm – 395nm and 480nm – 510nm
	ADA 48 specifies power limitations within specific wavelength bands.The VALO CORDLESS complies with ADA 48
Image: graph of wavelength vs power
Light intensity	* Standard power ~ 1000mw/cm2 +/-10%* High power – 1400mw/cm2 +/-10%

Performance Data:

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K110582

	† Xtra Power - 3200mw/cm2 +/- 20% (formerly called 'Plasma Emulation')* As measured by a Demetron® L.E.D, Radiometer† As measured by a spectrum analyzerDen-Mat® Sapphire Plasma Arc Curing Light – Irradiance measured at 2,600mW/cm2 with a spectrum analyzer
--	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The following three tests were conducted along with bench tests described in the 510(k); depth of cure, software verification and validation and IEC 60601-1 Electrical Safety.

Conclusion:

able able and in a

	VALO®(K083647)	VALO® Cordless
Power Supply	Wall powered, 12VDC, medical grade with adapters for International capabilityUL Approved	Same
Indications For Use	Source of illumination for curing photo-activated dental restorative materials and adhesives.	Same
Structure	Ergonomic wand	Same
Light	Blue and UV wavelengths	Same
Current control	Regulates current in the light source	Same
Buttons	Two buttons that function the light	Same
Power ON button	Located on handle of wand	Same
Power cord	8' length	Same
Time	Device indicates time and time selection	Same
Power Rating	Plasma Emulation Mode is 4500mW/cm²	Xtra Power mode is 3200mW/cm²
Operation	110VAC	110VAC

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Image /page/3/Picture/0 description: The image shows the word "K110582" written in black ink on a white background. The handwriting is somewhat stylized, with the numbers and letters slightly overlapping. The text appears to be handwritten and is oriented diagonally across the image.

Substantial Equivalence:

The VALO™ SCOUT is substantially equivalent to the VALO™ which is also manufactured by Ultradent Products, Inc. These two products are manufactured from the same materials, utilize many of the same components, are calibrated to the same levels and parameters, are used in the same manner and fashion, and are designed to operate and function in a near identical manner. The VALO™ SCOUT was designed to be the VALO™ but without the cord. The programming code is near identical, save micro-controller variations and enhanced safety features. Both products have the same intended use and technological characteristics. Both products are safe and effective when used for as intended and for the purposes described. The following three tests were conducted along with bench tests described in the 510(k); depth of cure, software verification and validation and IEC 60601 Electrical Safety.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Diane Rogers Regulatory Affairs Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

APR 2 8 2011

Re: K110582

Trade/Device Name: VALO® Cordless Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: April 1, 2011 Received: April 5, 2011

Dear Ms. Rogers:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Rogers

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Statement of Indications for Use

510(k) Number (if known): _ KI | 0582

VALO® Cordless Device Name: __

Indications for Use:

Source of illumination for curing photo-activated dental restorative materials and adhesives.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Purry

510(k) Number:

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

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(Posted November 13, 2003)

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.