The Fraxel II SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.

AI/ML Overview

The provided document is a 510(k) summary for the Fraxel II SR Laser System. This type of document focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a clinical study designed to meet them in the way a traditional clinical trial report would.

Therefore, the information requested in your prompt regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be fully extracted from the provided text. The document states that "Sufficient safety data has been gathered to determine that the Fraxel II Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced." This is a general statement rather than a detailed report of a study meeting specific acceptance criteria.

However, I can provide what information is available and indicate what is not present.

Acceptance Criteria and Study for Fraxel II SR Laser System

Based on the provided 510(k) summary, the device's acceptance was predicated on demonstrating substantial equivalence to existing legally marketed predicate devices, particularly the Fraxel SR Laser System (K050841). The primary "acceptance criteria" here is that the device performs "as clinically intended" and introduces "no new issues of safety and effectiveness" compared to the predicate.

The document does not detail specific quantitative acceptance criteria or a dedicated study with defined endpoints to "prove" the device meets these criteria in the way a pre-market approval (PMA) would require. Instead, it relies on the safety and performance of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance (from K060310)
Substantial equivalence in Indications for Use to predicate devices.	"Substantial equivalence for the Fraxel II SR Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements." (Indication statements are listed in section 5).
Device performs as clinically intended (consistent with predicate).	"Sufficient safety data has been gathered to determine that the Fraxel II Laser System and Accessories performs as clinically intended..."
No new issues of safety and effectiveness introduced compared to predicate.	"...and that no new issues of safety and effectiveness are introduced."
Key technological characteristics (energy type, operating principle) are equivalent to predicate.	"Key technological characteristics of the Fraxel II SR Laser System, such as energy type and operating principle, are equivalent to the Fraxel SR Laser System..."

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

The document states: "Clinical analysis was conducted on Non-Significant Risk and IDE Reliant studies to support the clinical performance of the Fraxel SR Laser System."
Sample Size: Not specified for any particular test set. The statement refers to "studies" in plural, implying prior data.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies are referred to as "Reliant studies," implying they were conducted by the manufacturer, Reliant Technologies, Inc., which is based in Mountain View, CA, USA.
Retrospective or Prospective: Not specified.

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 510(k) summary. The summary does not describe a clinical study in detail that would involve establishing a ground truth with a specific number of experts or their qualifications.

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

This information is not provided in the 510(k) summary.

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

No. This document describes a laser system for dermatological procedures, not an AI-assisted diagnostic device. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable and was not performed.

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

No. This is a hardware device (laser system) for direct treatment application by a medical professional, not an algorithm for standalone performance evaluation.

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

This information is not explicitly provided. The "clinical analysis" mentioned likely relied on clinical endpoints and physician assessments related to the effectiveness of the laser in treating the indicated conditions (e.g., reduction in wrinkles, lightening of pigmented lesions, improvement in skin texture), which would fall under outcomes data and expert clinical assessment.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device that utilizes a "training set" in the computational sense. The "clinical analysis" referenced for performance would be based on prior trials/studies of the Fraxel SR Laser System and other related devices, but specific sample sizes for these prior studies are not detailed here.

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

This is not applicable for the reasons stated in point 8.

Summary

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Reliant Technologies, Inc.

MAR 2 9 2006

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

K060310

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

Heather Tanner Reliant Technologies, Inc. 464 Ellis St. Mountain View, CA 94043 650 641-5861 650 473-0537 fax htanner@reliant-tech.com

NAME OF DEVICE

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

LEGALLY MARKETED PREDICATE DEVICES

Name: Fraxel SR Laser System and Accessories 510(k) #: K050841

Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060

DEVICE DESCRIPTION

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INDICATION FOR USE STATEMENT

The Fraxel II SR Laser System 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

Indications for Use

Substantial equivalence for the Fraxel II SR Laser System and Accessories 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 Reliant studies to support the clinical performance of the Fraxel SR Laser System. Sufficient safety data has been gathered to determine that the Fraxel II Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced.

Technological Characteristics

Key technological characteristics of the Fraxel II SR Laser System, such as energy type and operating principle, are equivalent to the Fraxel SR Laser System as described in submission K050841, K042319, K040617 and K031795.

CONCLUSION

Based on the design, materials, function, intended use and clinical evaluation, the Fraxel II Laser System and Accessories is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. No changes are being made in the laser wavelength or operating principle. Safety and effectiveness are reasonably assured, justifying 510(k) clearance.

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| D |

PREDICATE DEVICES

Name: Fraxel SR Laser System 510(k) #: K053047

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

DEVICE DESCRIPTION

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three lines forming its body and wings, symbolizing health, human services, and well-being. The seal is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2006

Reliant Technologies, Incorporated c/o Ms. Heather Tanner 464 Ellis Street Mountain View, California 94043

Re: K060310

Trade/Device Name: Fraxell II SR Laser System and Accessories 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: February 2, 2006 Received: February 7, 2006

Dear Ms. Tanner:

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 practicc requirements as set

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Page 2 – Ms. Heather Tanner

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 (240) 276-0115. 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.

Halent Semen co

Mark N. Melkerson 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): K 060310

Device Name: Fraxel II SR Laser System and accessories Indications For Use:

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), melasma 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 ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helene Lemercier

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

Page 1 of

510(k) Number Kob6310

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.