The Reliant Laser System II consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatological procedures. The system includes scanning and focusing optics to deliver a pattern of microscopic treatment zones (MTZs) to the epidermis and upper dermis. Device attachments and pre-treatment solution are also included.

AI/ML Overview

The provided document is a 510(k) summary for the Reliant Laser System II. It describes the device, its intended use, and states that clinical performance data was used to demonstrate its function and safety. However, it does not contain specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Here's a breakdown based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Information provided in the document:

The document states: "Results of clinical evaluations were used to demonstrate that the Reliant Technologies Laser System II functioned as intended. Sufficient data have been gathered from clinical studies to determine that the Reliant Laser System II performs as clinically intended, and no issues of safety and effectiveness are introduced."

Missing Information:

Specific Acceptance Criteria: The document does not define any quantitative or qualitative acceptance criteria that the device was tested against (e.g., a specific percentage reduction in wrinkles, a certain lesion clearance rate, or a defined safety threshold).
Reported Device Performance: While it states the device "functioned as intended" and "performs as clinically intended," it does not provide any specific metrics, data, or results from the clinical evaluations to substantiate this claim.

2. Sample Size for the Test Set and Data Provenance

Missing Information:

Sample Size: The document does not mention the number of subjects or cases included in any clinical evaluation or test set.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only generically refers to "clinical evaluations" and "clinical studies."

3. Number of Experts and their Qualifications for Ground Truth

Missing Information:

The document does not describe the establishment of a "ground truth" using experts for any test set.
It does not mention the number or qualifications of any experts involved in reviewing the clinical outcomes or data for the studies.

4. Adjudication Method for the Test Set

Missing Information:

Since the document doesn't detail a test set or ground truth establishment process involving experts, an adjudication method is also not mentioned.

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

Missing Information:

The document does not mention any MRMC comparative effectiveness study, nor does it discuss human readers, AI assistance, or an effect size. Laser devices like this typically focus on direct physiological effects rather than diagnostic interpretation assisted by AI.

6. Standalone (Algorithm Only) Performance Study

Missing Information:

This is a standalone device in the context of a laser system, meaning it functions directly on the patient, not as a diagnostic algorithm that processes data. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as it relates to AI algorithms is not applicable here and no such study is mentioned or implied.

7. Type of Ground Truth Used

Missing Information:

The document does not specify the type of ground truth used. For a laser device, "ground truth" would typically refer to clinical outcomes validated through physician assessment, patient satisfaction, or objective measurements (e.g., imaging, biopsies for lesion clearance), but no specifics are provided.

8. Sample Size for the Training Set

Missing Information:

The document does not refer to any "training set." This term is specific to machine learning algorithms, which is not the nature of this medical device (a laser system).

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

Missing Information:

As there is no mention of a "training set" (due to the nature of the device), there is no information on how its ground truth was established.

In summary, the provided 510(k) summary for the Reliant Laser System II broadly states that clinical evaluations demonstrated the device performs as intended and is safe and effective. However, it lacks the detailed information required to answer most of the specific questions about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment. This level of detail is typically found in the full 510(k) submission, not necessarily in the publicly available summary.

Summary

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K040617 1 of 2

Reliant Technologies, Inc. Reliant Laser System II 510(k) Premarket Notification

510(k) SUMMARY

As required by Section 12 of the Medical Devices Act of 1990, Reliant technologies, Inc.
Continent of the Medical Conciler overlies arealished for Relight As required by Section 12 of the Medical Do reess information available for Reliant
is providing a summary of safety and effectiveness information available for Reliant is providing a summaly of surces and errost Announce substantial equivalence decision making process.

Submitter:	Reliant Technologies, Inc.
Address:	260 Sheridan Ave.Suite 309Palo Alto, CA 94306
Contact Person:	Heather TannerClinical and Regulatory Affairs
Telephone:	(650) 473-0200 ext. 103
Facsimile:	(650) 473-0357
Date prepared:	March 5, 2004
Device Trade Name:	Reliant Laser System II
Common Name:	Dermatology Laser
Classification Name:	Laser Surgical Instrument21 C.F.R § 878.4810
Legally Marketed Predicate Devices:	-Reliant Laser System K031795-Altus Medical CoolGuide Lasers w/PulseLight Handpiece K023954-Aramis II Dermatological Laser K023734-Candela Smoothbeam Laser SystemK030846-Candela YAG Family of LasersK033172-Lumenis Ultrapulse Encore Laser,K022060

Description of the Reliant Laser System II:

The Reliant Laser System II consists of a set of fiber lasers, controlled by an embedded The Reliant Laser System if consists of a set of the estanting and focusing optics processor, to be used in demiatores). The issores and upper dermis. Device to defiver a pattern of enttachments and pre-treatment solution.

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KC40617 2082

Indications for use of Reliant Laser System II:

The Reliant Laser System II is intended for:

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles;

Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia.

Performance Standards:

As a laser product, the Reliant Laser System II is required to conform and does conform to the Laser Performance Standard (21 CFR).

SUBSTANTIAL EQUIVALENCE COMPARISON

The technological characteristics and indications for use of the Reliant Laser System II The technological characteristics addicate laser devices. These devices are equivalent in are simmal to those of the entra product specification, and product specifications. Any terms of design, materials, principal on open II and the predicate devices do not raise new issues regarding safety or effectiveness.

Clinical Performance Data

Results of clinical evaluations were used to demonstrate that the Reliant Technologies Results of Childed everalations were ally intended. Sufficient data have been gathered Laser System II functioned as onlinear. Anteneral
from clinical studies to determine that the Reliant Laser System II performs as clinically iron ennied stadies to avissues of safety and effectiveness are introduced.

CONCLUSION

Based on the design, materials, function, intended use, and clinical evaluation, the Reliant Dased on the design, materially equivalent to the devices currently Technologies Laser Dystem II 18 July and Cosmetic Act. In addition, the Reliant marketed under the Federal Food, Brag and Catety or effectiveness issues. Therefore, rechnologics Luser by Sective as are reasonably assured, justifying 510(k) clearance for commercial sale.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure.

Public Health Service

JUN 1 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Heather Tanner Clinical and Regulatory Affairs Reliant Technologies, Inc. 260 Sheridan Avenue, Suite 309 Palo Alto, California 94306

Re: K040617 Trade/Device Name: Reliant Laser System II 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: May 5, 2004 Received: May 6, 2004

Dear Ms. Tanner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to Conniner of May 20, 11:25 PM ] List accordance with the provisions of the Federal Food, DNA (A de vices that have been receasined require approval of a premarket approval application (PMA). and Cosmetic rear (110c) that to nevice, subject to the general controls provisions of the Act. The r ou may, diorelore, maints of the Act include requirements for annual registration, listing of gencral controls provisions of wactice, 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 If your device is classified (500 a0010) ins. Existing major regulations affecting your device can may be subject to suen additional controller in 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 Picase oe advised that I DA 3 issualles or our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of ally it cuchar statules and regaraments ancluding, but not limited to: registration and listing (21 Comply with an the Her 811 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 101111 the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Heather Tanner

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maxing of substantial equivalence of your device to a legally premarket notification. The PDA miding of backand 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 If you desire specific advice for your ac 110 cm. Also, please note the regulation entitled, and contact the Office of Complanes at (so t notification" (21CFR Part 807.97). You may obtain Misolanding by telefono to premaintentibilities under the Act from the Division of Small other gelleral informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam 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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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Reliant Technologies Laser System II

Indications For Use:

The Reliant Technologies Laser System II is intended for:

-Dermatological procedures requiring the coagulation of soft tissue;

-Treatment of periorbital wrinkles;

-Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia.

Prescription Use_ X (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)

Miriam C. Provost

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

Page	1 of ________
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510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.