The SLED CURING LIGHT is a cordless battery-powered unit designed for curing VLC materials whose initiators are sensitive to light in the 450-475 nm wavelength region of the visible spectrum. The light is based on LED (light emitting diodes) technology for light generation. The SLED CURING LIGHT SYSTEM includes: Handpiece with an LED and control electronics, Tapered fiber-optic probe to deliver the light to a well-defined site, Battery for sustained electronic power, Base unit - charges battery - stores handpiece when not in use, Transformer to supply wall power to the base unit, Optional amber-colored eye shield. The SLED CURING LIGHT handpiece contains three switches: one trigger to turn the curing LED on and off and two mode switches to cycle the curing time and type through several different settings. The battery in the handpiece is contained in a user-serviceable compartment.

AI/ML Overview

Here's an analysis of the provided information regarding the SLED CURING LIGHT SYSTEM, focusing on the absence of specific acceptance criteria and study details.

Based only on the provided text, there is no detailed information about acceptance criteria or specific studies that prove the device meets those criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance data from a specific study with defined acceptance criteria.

The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device specifications and intended use, and may include some performance data to confirm equivalence, but it doesn't typically require the same level of detailed clinical or performance study reporting as a PMA (Premarket Approval).

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.

Here's how I would present the information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Intended Use	Curing camphorquinone-based visible light cured (VLC) materials.	"Curing camphorquinone-based visible light cured (VLC) materials."	The device's intended use matches the predicate. This is a functional equivalence, not a quantitative performance metric with an acceptance threshold.
Technological Characteristics	- Intended use, appearance, design (source placement, probe style, on-board radiometer, control circuit, handpiece style) substantially equivalent to K982318 (Spectrum™ 800 Curing Unit). - Intended use, operation (range of light emitted, curing time, cooling) substantially equivalent to K000393 (Nova Cordless Light).	"The SLED CURING LIGHT SYSTEM is substantially equivalent to K982318 in intended use, appearance and design, including source placement, probe style, on-board radiometer, control circuit, handpiece style." "The SLED CURING LIGHT SYSTEM is substantially equivalent to K000393 in intended use, operation, including the range of light emitted, curing time, and cooling."	These are statements of substantial equivalence, which is the primary "acceptance criterion" for a 510(k). No specific quantitative performance metrics or thresholds are provided in this summary. The "performance data provided" is mentioned but not detailed.
Safety and Effectiveness	Implied to be safe and effective for indicated use.	"We believe the similarity of the SLED CURING LIGHT SYSTEM to the legally marketed predicate devices and the performance data provided support the safety and effectiveness of the SLED CURING LIGHT SYSTEM for the indicated use."	No specific safety or effectiveness metrics or studies are described. The conclusion is based on substantial equivalence to predicate devices, which are assumed to be safe and effective.

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

Not specified. The document does not describe any specific test set for an independent performance study. The "performance data provided" is mentioned in a general way, but its nature, sample size, or provenance are not detailed.

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 applicable/Not specified. There is no description of a test set requiring expert ground truth establishment.

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

Not applicable/Not specified. There is no description of a test set requiring adjudication.

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 curing light, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a physical medical device, a curing light, not an algorithm.

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

Not specified. No specific ground truth methodology is described in this document. Substantial equivalence relies on comparing the device's characteristics and performance to known predicate devices.

8. The sample size for the training set

Not applicable/Not specified. This is not an AI/machine learning device that would typically have a "training set."

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

Not applicable/Not specified. As above, no training set is described.

Summary of what the document does provide:

Device Name: SLED CURING LIGHT SYSTEM
Intended Use: Curing camphorquinone-based visible light cured (VLC) materials.
Predicate Devices: Spectrum™ 800 Curing Unit (K982318) and Nova Cordless Light (K000393).
Basis for Approval: Substantial equivalence to the predicate devices in intended use, appearance, design, operation, range of light emitted, curing time, and cooling. The document states that "performance data provided" supports safety and effectiveness, but it does not elaborate on what that data entails.

Summary

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Image /page/0/Picture/0 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. Above the word, there is a handwritten number "K031615" in black ink. The number is written diagonally across the top left corner of the image.

510(k) SUMMARY

NAME & ADDRESS:

JUL 2 1 2003

P. J. Lehn Telefax (717) 849-4343

P. Jeffery Lehn CONTACT:

May 22, 2003 DATE PREPARED:

TRADE OR PROPRIETARY NAME: SLED CURING LIGHT SYSTEM visible light cure for polymerization CLASSIFICATION NAME:

	PREDICATE DEVICES: Spectrum™ 800 Curing Unit	982318
	Nova Cordless Light	000393

DEVICE DESCRIPTION:

The SLED CURING LIGHT SYSTEM includes:

. Handpiece with an LED and control electronics
Tapered fiber-optic probe to deliver the light to a well-defined site .
Battery for sustained electronic power ●
. Base unit - charges battery
- stores handpiece when not in use
Transformer to supply wall power to the base unit ●
Optional amber-colored eye shield .

The SLED CURING LIGHT handpiece contains three switches: one trigger to turn the curing LED on and off and two mode switches to cycle the curing time and type through several different settings. The battery in the handpiece is contained in a user-serviceable compartment.

DENTSPLY International
570 West College Avenue
P.O. Box 872
York, PA 17405-0872
(717) 845-7511
Fax (717) 849-4762

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510(k) SUMMARY (cont'd.)

. "

INTENDED USE:

. . .

Curing camphorquinone-based visible light cured (VLC) materials.

TECHNOLOGICAL CHARACTERISTICS:

The SLED CURING LIGHT SYSTEM is substantially equivalent to K982318 in intended use, appearance and design, including source placement, probe style, on-board radiometer, control circuit, handpiece style.

The SLED CURING LIGHT SYSTEM is substantially equivalent to K000393 in intended use, operation, including the range of light emitted, curing time, and cooling.

We believe the similarity of the SLED CURING LIGHT SYSTEM to the legally marketed predicate devices and the performance data provided support the safety and effectiveness of the SLED CURING LIGHT SYSTEM for the indicated use.

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Image /page/2/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is an image of an eagle with its wings spread. The eagle is facing to the right and has three stripes on its chest.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2003

Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 17405- 0872 York, Pennsylvania

Re: K031615

Trade/Device Name: SLED CURING LIGHT SYSTEM Regulation Number: 872. 6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBT Dated: May 22, 2003 Received: May 27, 2003

Dear Mr. Lehn:

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. Lehn

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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely yours,

fothun

Susan Runner, DDDS, MA Interim 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 STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known): K031615

Device Name:

SLED CURING LIGHT SYSTEM

Indications for Use:

Curing camphorquinone-based visible light cured (VLC) materials.

RS Betz DDS for Dr. K. Mulry

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

510(k) Number

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.