Please note that the provided document is a 510(k) summary for the Candela GentleYAG Laser System, which focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting detailed acceptance criteria and a deep dive into a standalone study for a novel AI device.

Therefore, many of the requested categories for AI device studies (especially relating to sample sizes, ground truth expert details, MRMC studies, training set details) are not applicable or not provided within this type of regulatory submission. This document describes a laser system, not an AI or software-as-a-medical-device (SaMD) product.

However, I will extract the available information and indicate where information is not present or not relevant to this type of device and submission.

Acceptance Criteria and Study Information (Based on Provided Document)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device is safe.	"The GentleYAG is safe and effective for the treatment of Pseudofolliculitis Barbae."
Effectiveness: Device is effective for the stated indication.	"The GentleYAG is safe and effective for the treatment of Pseudofolliculitis Barbae."
Substantial Equivalence: Device shares indications for use, key design aspects, similar wavelength, and/or same maximum delivered power as predicate devices.	"The Candela GentleY AG Laser shares the same indications for use, matches key design aspects, including spot size, similar wavelength and/or the same maximum delivered power as the predicate devices, and therefore is substantially equivalent to the predicate devices."
No New Questions of Safety/Effectiveness: Device does not introduce new risks/benefits compared to predicates.	"Technologically, the Candela GentleY AG Laser is identical to the previous predicate Candela Long Pulse Nd: YAG Laser (K010104), the Laserscope Lyra Surgical Laser System (K003147) and the Altus CoolGlide Laser (K014040), therefore the risks and benefits for the GentleY AG Laser are comparable to these predicate device (s). We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the device."

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document states that "A clinical study produced results that indicate the GentleY AG is safe and effective for the treatment of Psuedofolliculitis Barbae." However, the sample size for this clinical study is NOT provided in the 510(k) summary.
Data Provenance: Not specified in this 510(k) summary (e.g., country of origin, retrospective/prospective). This level of detail is typically in the full submission, not the summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable/Not provided. For a laser device, "ground truth" as conceived for AI diagnostic devices (e.g., expert consensus on images) is not directly relevant. The clinical study would involve patient outcomes assessed by clinicians, but the number or specific qualifications of experts establishing "ground truth" in the AI sense are not discussed.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Adjudication methods (like 2+1) are typically for resolving discrepancies in expert interpretations, common in AI diagnostic tool evaluation. This is not mentioned for this laser device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic AI systems where human readers interpret cases with and without AI assistance. The Candela GentleYAG is a therapeutic laser device.
Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

No. This is a laser system, not an algorithm. Therefore, a standalone (algorithm only) performance study as understood for AI software is not relevant or applicable. The reported performance refers to the full device.

7. Type of Ground Truth Used

For the effectiveness claim, the "ground truth" would implicitly be clinical outcomes observed in patients treated for Pseudofolliculitis Barbae during the clinical study. The specifics of how these outcomes were measured or confirmed (e.g., physician assessment, patient self-report, objective measurements) are not detailed in this summary.

8. Sample Size for the Training Set

Not applicable. This is a hardware medical device, not an AI algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. No training set for an AI algorithm is involved.

Summary of Limitations due to Document Type:

This 510(k) summary focuses on demonstrating that a new medical device (a laser system) is "substantially equivalent" to existing legally marketed devices. It is not designed to present a detailed AI performance study. Consequently, most questions related to AI-specific study methodologies (like sample sizes for test/training sets, expert qualifications for ground truth, adjudication, MRMC studies) are not addressed or are not applicable within this document. The core argument for safety and effectiveness for this device relies on its technological similarity to approved predicate devices and the results of a generic "clinical study" without detailing its methodology in this summary.

Summary

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DEC 2 0 2002

亿元3193

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510/k) Summary of Safety and Effectiveness for the Candela GentleYAG Laser System is being submitted in accordance with the requirements of the SMDA 1990, 21 CFR 807.92 and follows the guidance concerning the organization and content of a 510(k) summary.

I. General Information

Applicant:	Candela Corporation
Address:	530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	Lorraine NelsonManager, Regulatory Affairs
Date Prepared:	September 24, 2002
II. Names
Device Trade Name:	GentleYAG Laser System
Common Name	Dermatology Laser
Classification:	Class II (21 CFR § 878.4810 Laser Surgical Instrumentfor use in General and Plastic Surgery and inDermatology)
III. Predicate Devices	Candela Long Pulse Nd: Yag Laser (K010104)Lyra Surgical Laser System (K003147)Altus Medical CoolGlide Laser (K014040)

IV. Product Description

The GentleY AG Laser consists of the following main components:

. a laser system console (including software and control electronics)
a control and display panel .
a lens-coupled, user replacement optical fiber handpiece .
. a skin cooling device integrated into the handpiece
a footswitch or handswitch .
a remote interlock connector .

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V. Indications for Use

The GentleY AG Laser is intended for the treatment of Pseudofolliculitis Barbae.

VI. Rationale for Substantial Equivalence

The Candela GentleY AG Laser shares the same indications for use, matches key design aspects, including spot size, similar wavelength and/or the same maximum delivered power as the predicate devices, and therefore is substantially equivalent to the predicate devices.

VII. Safety and Effectiveness Information

The new indications for use are based on the indications for use for the predicate laser systems.

A clinical study produced results that indicate the GentleY AG is safe and effective for the treatment of Psuedofolliculitis Barbae.

Technologically, the Candela GentleY AG Laser is identical to the previous predicate Candela Long Pulse Nd: YAG Laser (K010104), the Laserscope Lyra Surgical Laser System (K003147) and the Altus CoolGlide Laser (K014040), therefore the risks and benefits for the GentleY AG Laser are comparable to these predicate device (s).

We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the device.

VIII. Conclusion

It is the opinion of Candela Corporation that the GentleY AG Laser System is substantially equivalent to the predicate devices based on operating principles, materials, mechanism of action, design, construction, methods of assembly and for the treatment of Psuedofolliculitis Barbae.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Candela Corporation Lorraine Nelson Manager. Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778-1886

Re: K023193

Trade/Device Name: Gentle Y AGTM Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 24, 2002

DFC 2 0 2002

Received: September 25, 2002

Dear Ms. Nelson:

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

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Page 2 - Ms. Lorraine Nelson

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) 594-4659. 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). 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

40 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

510(k) Number (if known): K023193

Device Name:

Gentle Y AG Laser System

Indication For Use:

The GentleYAG Laser System is intended for the treatment of Pseudofolliculitis Barbae.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
K023193
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

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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.