The Solstice is a Light Emitting Diode (LED) visible light used for the polymerization of light-cured materials by dental professionals. The Solstice consists of an LED curing handpiece and a charging system. The plastic molded handpiece contains an LED light engine, battery, and printed circuit board containing the electronics. A digital circuit and microprocessor will be utilized to control two (2) different curing modes (10 and 20 seconds). Each mode specifies LED curing output and audible beep timing. The Solstice uses a single pushbutton trigger to activate the LED curing output and select the curing mode.

AI/ML Overview

This document describes the Solstice LED Curing Light, identified by K102621, and its substantial equivalence to the predicate device, Kerr Corporation's Demi. The device is intended for the polymerization of light-cured materials by dental professionals.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria or a direct comparison table for performance metrics between the Solstice and the predicate device. However, it mentions specific performance aspects for which data was submitted to demonstrate substantial equivalence.

Performance Metric	Acceptance Criteria (Implicit)	Solstice Performance	Study/Proof
Biocompatibility	Non-toxic, non-irritating	Representative resin (similar to handle material) passed biocompatibility tests.	Statement from component manufacturer.
Depth of Cure	Comparable to predicate device	Data included in submission demonstrating performance compared to predicate.	Non-Clinical Test Data
Irradiance	Appropriate light intensity and peak wavelength for curing dental materials	Data included showing light intensity and peak wavelength.	Non-Clinical Test Data
Software Validation	Software functions as intended	Successfully validated.	Non-Clinical Test Data
Thermal Management	Does not require a cooling fan (i.e., operates within acceptable temperature limits without external cooling)	Temperature data demonstrated no cooling fan needed.	Non-Clinical Test Data
Light Output Stability	Constant light output during curing (unlike predicate which has shifting output)	Emits a constant light output.	Device Description / Non-Clinical Test Data

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

The document does not specify a distinct "test set" in the context of machine learning or AI. Instead, it refers to non-clinical tests conducted on the device itself or representative materials.

Biocompatibility: "samples from typical production lots of the resin" were tested. No specific number is given.
Depth of Cure, Irradiance, Thermal Management: Data was generated from testing the Solstice device. The sample size (number of devices, number of measurements) is not provided.
Data Provenance: All data appears to be prospective and generated by Sybron Dental Specialties Inc. or its component manufacturers in the United States (Orange, CA, where the submitter is located).

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

Not applicable. This device is a medical instrument, not an AI/ML product where expert-established ground truth for a test set would be relevant. The performance evaluation is based on objective physical and chemical measurements.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this relates to expert review of data for AI/ML models, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

Not applicable. This is a medical device, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests:

Biocompatibility: The "ground truth" is established by standard biocompatibility testing protocols, with the definition of "passing" those tests serving as the benchmark.
Depth of Cure, Irradiance, Thermal Management: The "ground truth" is derived from direct physical measurements of the device's output and behavior, and comparison against established scientific/engineering principles for effective light curing and safety, as well as comparison to the predicate device's known performance.
Software Validation: The "ground truth" is defined by the software requirements and specifications, with successful validation meaning the software performs according to these predefined criteria.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning and therefore does not have a "training set."

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

Not applicable. See #8.

Summary

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K102621

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JAN 2 8 2011

Section III - 510(k) Summary of Safety and Effectiveness

Submitter: Sybron Dental Specialties Inc. 1717 West Collins Avenue Orange, CA 92867 714-516-7602 - phone 714-516-7472- fax Wendy Garman - Contact Person Date Summary Prepared: September 2010

Device Name:

. Trade Name - Solstice
. Common Name - L.E.D. Curing Light
Classification Name Ultraviolet activator for polymerization, per 21 § CFR 872.6070 .

Devices for Which Substantial Equivalence is claimed:

. Kerr Corporation, Demi

Device Description:

Intended Use of the Device:

The intended use of the Solstice is for the polymerization of light-cured materials by dental professionals.

Substantial Equivalence:

The Solstice is substantially equivalent to one other legally marketed device in the United States. The Solstice functions in a manner similar to and is intended for the same use as the Demi, manufactured by Kerr Corporation.

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The Solstice is similar to the Demi in that it is a cordless battery-operated device, uses LED as the light source, and has user-selectable curing modes. The Solstice differs from the Demi in that the Solstice does not utilize a light guide to direct the light from the body of the light guide, but rather the LEDs are mounted at the tip of the unit. The Solstice does not require a cooling fan, as demonstrated by temperature data which has been included in this submission. The Solstice uses a Lithium Iron Phosphate battery, as opposed to the Lithium lon battery of the Demi. Unlike the Demi, which during use shifts light output intensity from 1100mW/cm- to 1300mW/cm-multiple times throughout the curing cycle, the Solstice emits a constant light output.

Non-Clinical Test Data:

Biocompatibility studies have been conducted on a representative resin similar to the resin used to produce the handle of the Solstice (the only difference is the color). Included in this submission is a statement from the component manufacturer indicating that samples from typical production lots of the resin were subjected to the biocompatibility tests and passed.

This 510(K) submission also includes depth of cure testing data used to evaluate the performance of the Solstice compared to the predicate device. Also included is irradiance data which demonstrates light intensity and peak wavelength.

The Solstice software has been successfully validated to confirm the performance of the device.

Clinical Test Data:

Clinical testing has not been conducted on this product.

Conclusion:

Based upon the biocompatibility studies, similar technological/performance characteristics as compared to the predicate device, and successful validation of the Solstice software, the clinical performance of the Solstice is deemed to be substantially equivalent to the Demi.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Kerr Corporation C/O Ms. Wendy Garman Sybron Dental Specialties 1717 West Collins Avenue Orange, California 92867

JAN 2 8 2511

Re: K102621 Trade/Device Name: Solstice Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: January 21, 2011 Received: January 24, 2011

Dear Ms. Garman:

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. Garman

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 (OS) 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/ucm115809.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,

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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

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Indications for Use

510(k) Number (if known): K |(2

Device Name: Solstice

Indications for Use:

The intended use of the Solstice is for the polymerization of light-cured materials by dental professionals.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: 150262

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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.