The Candela GentleLASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the target area via optical fiber/handpiece delivery system. The laser output energy is delivered via an optical fiber to a handpiece, which produces a circular beam on the skin. The GentleLASE Family of Laser Systems are designed with six major components:

High voltage power supply and modulator system
Optical laser head
Circulator system
Optical delivery system
Software control system
The Candela GentleLASE Family of Laser Systems are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Candela GentleLASE Family of Laser Systems. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this document.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria for clinical performance or detailed device performance metrics. Instead, it relies on demonstrating adherence to established safety standards and substantial equivalence to predicate devices.

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (as stated in document)
Conformance to Laser Performance Standard (21 CFR 1040)	The Candela GentleLASE Family of Laser Systems conforms to 21 CFR 1040.
Conformance to UL 2601 Electrical Safety Standard	The Candela GentleLASE Family of Laser Systems conforms to UL 2601.
Conformance to Harmonized Standard EN 60601-1-2	The Candela GentleLASE Family of Laser Systems conforms to EN 60601-1-2.
Substantial Equivalence to Predicate Devices (Candela GentleLASE GL - K994260) in terms of intended use, operating principles, design aspects, spot size, wavelength, and fluence.	The Candela GentleLASE Family of Laser Systems has the same intended use, utilizes similar operating principles, design aspects, spot size, wavelength, and fluence as the predicate devices.

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

This information is not present in the document. The submission states that the "indications for use for the treatment of benign pigmented lesions is based on a controlled clinical study using a device that has been cleared for use in the market." This implies reliance on data from the predicate device's studies, not new data from a specific test set for this 510(k) submission.

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)

This information is not present in the document. As stated above, the submission refers to prior studies on the predicate device.

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

This information is not present in the document.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in the device. This device is a laser system.

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

This is not applicable as the device is a laser system, not an algorithm, and it is intended for use by a human operator.

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

This information is not present for a specific clinical study conducted for this 510(k) submission. The document implies that the predicate device's clinical evidence (which would have required some form of ground truth for assessing treatment of benign pigmented lesions, likely based on clinical assessment or possibly photographic evidence over time) is being leveraged.

8. The sample size for the training set

This information is not present in the document. As the submission relies on substantial equivalence and safety standards, a "training set" in the context of an AI/algorithm is not applicable here.

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

This information is not present in the document.

Summary

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MAR 3 1 2003

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General Information:

This 510/k) is to provide notification of substantial equivalence for the Candela GentleLASE Family of Laser Systems, which is substantially equivalent to previously marketed devices . The GentleLASE Family of lasers is indicated for use for the treatment of benign pigmented lesions.

Submitted by:	Candela Corporation530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	William H. McGrail
Date prepared:	December 30, 2002
Classification:	Class II (21 CFR § 878.4810 Laser Surgical Instrument for use inGeneral and Plastic Surgery and in Dermatology)
Common Name:	Dermatology Laser, GentleLASE Family of Laser Systems
Predicate Devices:	Candela GentleLASE GL (K994260)

Description:

】. High voltage power supply and modulator system
Optical laser head 2.
1. Circulator system
1. Optical delivery system
న్. Software control system

The Candela GentleLASE Family of Laser Systems are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

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Testing:

As laser products, the GentleLASE Family of laser Systems are required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the GentleLASE Family of Laser Systems conforms to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2. Part 2 established by and required by the European Community.

Safety and Effectiveness Information:

The indications for use for the treatment of benign pigmented lesions is based on a controlled clinical study using a device that has been cleared for use in the market. We therefore believe that there are no questions of safety or effectiveness raised by the introduction of the Candela GentleLASE Family of Laser Systems.

Summary of Substantial Equivalence:

The Candela GentleLASE Family of Laser Systems have the same intended use, utilizes similar operating principles, design aspects, spot size, wavelength, and fluence as the predicate devices.

On the basis of similarities in methods of assembly, method of operation, and intended uses. Candela Corporation believes that the Candela GentleLASE Family of Laser Systems is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with the top profile being the most prominent.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2003

Mr. William H. McGrail Vice President of Research & Development and Operations Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778-1886

Re: K024371

Trade/Device Name: Candela GentleLASE Family of Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 30, 2002 Received: December 31, 2002

Dear Mr. McGrail:

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.

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.

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Page 2 - Mr. William H. McGrail

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) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE STATEMENT

< 09.4771 510(k) Number (if known):

Candela GentleLASE Family of Laser Systems Device Names

Indications For Use:

1. Treatment of benign pigmented lesions
  (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

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K02437/

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.