The Reliant Laser System II consists of a set of fiber lascrs, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal cnergy to the cpidermis and upper dermis. Device accessories include tip attachments and pre-treatment solution.

AI/ML Overview

The provided text is for a Premarket Notification (510(k)) for the Reliant Laser II System and Accessories, specifically for a labeling change. It asserts substantial equivalence to predicate devices and describes the device, its indications for use, and a conclusion about its safety and effectiveness.

However, the document does not contain specific acceptance criteria, performance metrics, or detailed study results that would typically be presented to prove the device meets acceptance criteria in the way a diagnostic AI device submission would. This 510(k) focuses on a labeling change and relies on previous clearances and clinical analysis performed on non-significant risk and IDE Reliant studies to support the change in the language of the indications for use statement, rather than presenting a new study with explicit performance metrics.

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text because such information is not present.

Here's a breakdown of what can be inferred or directly stated from the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Not explicitly defined in this document. The document asserts the device "performs as clinically intended" and that "no new issues of safety and effectiveness are introduced" due to the labeling change.	Not explicitly defined in this document. The document states that "Sufficient safety and efficacy data has been gathered" from prior studies to support the change in indications for use. Specific performance metrics (e.g., success rates for wrinkle reduction, lesion clearance, or complication rates with numerical values) are not provided in this 510(k) summary.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in this document. The document refers to "Non-Significant Risk and IDE Reliant studies" as the source of clinical analysis, but does not provide details on their sample sizes or methodologies.
Data Provenance: Not specified. The document vaguely refers to "Reliant studies," implying internal company studies, but no information on country of origin or whether they were retrospective or prospective is given here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document refers to "clinical analysis" and "clinical evaluation" but does not detail the methodology for establishing ground truth or the involvement of experts in these studies.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to this submission. The device is a laser system, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned.

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.

7. The type of ground truth used

This is not explicitly stated. Given it's a dermatological laser for treatments like wrinkle reduction and lesion photocoagulation, the ground truth would likely involve clinical assessments of treatment outcomes (e.g., photographs, qualitative/quantitative scales for wrinkle severity, lesion clearance, skin texture improvements, and histology for tissue coagulation if applicable). However, the document does not specify how ground truth was established for the underlying studies.

8. The sample size for the training set

This is not applicable as the device is a physical laser system, not a machine learning algorithm requiring a "training set."

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

This is not applicable for the same reason as above.

Summary of Device and its Purpose (from the text):

The Reliant Laser II System (Fraxel SR Laser System) is a laser surgical instrument intended for dermatological procedures. This 510(k) is for a labeling change, expanding its indications for use to include:

Dermatological procedures requiring the coagulation of soft tissue.
Treatment of periorbital wrinkles.
Photocoagulation of pigmented lesions (lentigos, solar lentigos, dyschromia).
Skin resurfacing procedures.

The submission asserts "substantial equivalence" to predicate devices and states that "Sufficient safety and efficacy data has been gathered" from prior "Non-Significant Risk and IDE Reliant studies" to support the expanded indications. However, the details of these studies and their specific performance metrics are not included in this document.

Summary

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Reliant Technologies, Inc.

. ﻧﻮﻣﺒﺮ

1 | 3

Premarket Notification:

K042319	Reliant Laser II System and Accessories, Labeling Change
MAR 10 2005

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

Heather Tanner
Reliant Technologies, Inc.
260 Sheridan Ave.
Palo Alto, CA 94306
650 473-0200, 103
650 473-0537 fax
htanner@reliant-tech.com

NAME OF DEVICE

Trade Name:	Reliant Laser II System and Accessories (Fraxel SR Laser System)
Common Name:	Laser Surgical Instrument
Regulation Number	878.4810
Product code:	GEX
Device Panel:	General Surgery/Restorative Devices
Device Classification:	Class II

PREDICATE DEVICES

Name: Reliant Laser System II
510(k) #: K040617
Name: Reliant Laser System
510(k) #: K031795
Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories
510(k) #: K022060

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Reliant Technologies, Inc.

2/3 042319

DEVICE DESCRIPTION

INDICATION FOR USE STATEMENT

The Reliant Laser System II is intended for use in:

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;

Skin resurfacing procedures.

SUBSTANTIAL EQUIVALENCE COMPARISON

Technological Characteristics

There has been no change to the Reliant Tcchnologics Laser System II. The system is identical to the Reliant Technologics 510(k)s cleared under 510(k) K031795 and K040617.

Indications for Use

Substantial equivalence for the Reliant Laser II System is supported by the predicate devices listed in this submission, which have identical or similar indication statements.

Clinical Performance Data

Clinical analysis was conducted on Non-Significant Risk and IDE Roliant studies to support the change in the language in the indications for use statement. Sufficient safety and efficacy data has been gathered to detenmine that the Roliant Lasor II $ ystem performs as clinically intended and that no new issues of safety and effectiveness are ntroduced.

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Reliant Technologies, Inc. Coup J 319 3/3

Premarket Notification: Reliant Laser II System and Accessories, Labeling Change

CONCLUSION

Based on the design, materials, function, intended use and clinical evaluation, the Reliant Based on the design, materials, Inneable, misalent to the devices currently Laso II System and Accessories IS Mostantially eqtic Act. Safety and effectiveness are marketed under the Foderal FOOG, 17ttig and Connect or being made in the laser reasonably assured, justifying >10(k) cicannee, rro onazged and clections performance data
or accessories. The technical, mechanical, performance, and cleared by this or accessories. The technical, mechanical, performatio, and unaffected by this change in labeling.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2005

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

Re: K042319

R042317
Trade/Device Name: Reliant Laser System II and Accessories (Fraxel SR Laser System) 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 7, 2004 Received: December 10. 2004

Dear Ms. Tanner:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your because roges for 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 encrosure) to regary the Medical Device Amendments, or to commerce pror to May 20, 11:37 | 11 accordance with the provisions of the Federal Food, DINE, de necs that here boon require approval of a premarket approval application (PMA). and Cosmetic Herefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration. Iisting of general controls provider in a practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it rr your de vice is one additional controls. Existing major regulations affecting your device can may oc subject to satin adallarian legulations. 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 r tease be advised that i Drivies and on over device complies with other requirements of the Act that 1197 has intact a and regulations administered by other Federal agencies. You must on any I 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 CI K Fat 6077, labeling (2 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic forth in the quinn control provisions (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 ocgin mankemig your antial equivalence of your device to a legally premarket nothication. The PDA midning of substantal. Popularian Por your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (1 CFR Part 80) ), please If you desire specific advice tor your ac not of the same of the regulation entitled. contact the Office of Compliance at (210) 216 - 101 (21CFR Part 807.97). You may obtain "Misbranding by relevence to premarket notifications in the Act from the Division of Snall other general information on your responsible in the live in the mumber (800) 638-204 or Manufacturers, International and Consulter Forse and Consectivindustry/support/index.html.

Sincerely yours,

sincerely yours,

Mark A. Wilkinson

Miriam C. Provost, Ph.D. Acting 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

910(k) Number (if known): K042319

Device Name: Reliant Laser System II and Accessories (Fraxel SR Laser System)

Indications For Use:

"The Reliant Laser System II is intended for use in:

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;

Skin resurfacing procedures."

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 ANDTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

mali A. Millheez

(Division Sign-Off)

al, Restorative. and Neurological Devices

510(k) Number K042319

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.