The Fraxel 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 upper dermis. Device accessories include tip attachments.

AI/ML Overview

This submission for the Fraxel SR Laser System (K050841) does not contain a specific study proving the device meets individual acceptance criteria in the format typically seen for AI-enabled devices or diagnostics. Instead, the submission relies on the concept of substantial equivalence to existing legally marketed predicate devices.

Here's an breakdown based on the provided text, addressing the points you requested where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not list specific numerical acceptance criteria (e.g., minimum sensitivity, maximum false positive rate) or present a table of device performance against such metrics. The core argument for acceptance is based on substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness comparable to predicate devices	"No new issues regarding safety or effectiveness"
Functions as clinically intended	"Functions as clinically intended"
Conformance to 21 CFR 1040 (Laser Product Regulations)	"Conforms to the requirements of 21 CFR 1040"
Effective for: - Coagulation of soft tissue	"Sufficient data have been gathered from clinical studies to determine that the Fraxel SR Laser System performs as clinically intended"
- Treatment of periorbital wrinkles
- Photocoagulation of pigmented lesions
- Skin resurfacing procedures

2. Sample Size Used for the Test Set and Data Provenance

The submission mentions "clinical investigations" and "clinical studies" but does not specify the sample size for any test set. It states: "Sufficient data have been gathered from clinical studies to determine that the Fraxel SR Laser System performs as clinically intended."

The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). It refers to "peer-reviewed publications and clinical investigations," which suggests a mix of existing literature and possibly some internal studies, but details are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The submission references "clinical studies" but does not detail the methodology for establishing ground truth within those studies or the role/qualifications of experts involved. Given the nature of a laser system for dermatological procedures, the "ground truth" would likely be clinical outcomes observed by dermatologists, but the specifics are not elaborated upon.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1). This level of detail regarding study design and independent review of results is not present in this 510(k) summary.

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

No, an MRMC comparative effectiveness study, especially one involving AI assistance, was not mentioned or relevant to this 2005 submission for a laser device. The Fraxel SR Laser System is a physical device, not an AI or diagnostic tool that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. As stated above, this is a physical laser device, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document implies the ground truth for device performance is based on clinical outcomes data from "clinical studies" and "peer-reviewed publications." For dermatological procedures like those listed, this would likely involve clinical assessments of improvements in skin conditions, reduction of wrinkles, or removal of lesions. However, the specific methodology for establishing this ground truth (e.g., scoring systems, objective measurements) is not detailed.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. Training sets are typically associated with machine learning or AI models. This submission is for a medical device (laser system), not an AI algorithm.

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

Not applicable. As the concept of a training set does not apply, neither does the method for establishing its ground truth.

Summary of Approach for this Device (K050841):

The regulatory strategy for the Fraxel SR Laser System in this 510(k) relied heavily on demonstrating substantial equivalence to existing predicate devices (Fraxel SR Laser System K043219, Palomar Starlux K033549, Sciton BBL System K032460). The manufacturer argued that:

The technological characteristics and indications for use were similar.
Differences did not raise new safety or effectiveness issues.
The device complied with regulatory standards for laser products (21 CFR 1040).
"Sufficient data" from clinical studies and peer-reviewed publications supported that the device functioned as intended and was safe and effective.

This approach is common for medical devices where a direct comparison to similar, already-approved devices can be made, rather than requiring extensive de novo clinical trials with detailed performance metrics against a rigorously established ground truth, as might be expected for novel diagnostic devices or AI solutions.

Summary

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JUL 5 - 2005

Reliant Technologies, Inc.

510(k) SUMMARY

As required by Section 12 of the Medical Devices Act of 1990, Reliant technologies, Inc. is providing a summary of safety and effectiveness information available for Reliant Technologies, Inc. Laser System, as well as the substantial equivalence decision making process.

Submitter:	Reliant Technologies, Inc.
Address:	260 Sheridan Ave., Suite 300Palo Alto, CA 94306
Contact Person:	Heather TannerClinical and Regulatory Affairs
Telephone:	(650) 473-0200 ext. 103
Facsimile:	(650) 473-0357
Date prepared:	March 31, 2005
Device Trade Name:	Fraxel SR Laser System
Common Name:	Dermatology Laser
Classification Name:	Laser Surgical Instrument21 C.F.R § 878.4810
Legally Marketed Predicate Devices:

Fraxel SR Laser System K043219 Palomar Starlux K033549 Sciton BBL System K032460

Description of the 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), melasma and dyschromia;

Skin resurfacing procedures.

Compliance to 21 CRF 1040

As a laser product, the Fraxel SR Laser System is required to conform and does conform to the requirements of 21 CFR 1040.

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Substantial Equivalence Comparison

The technological characteristics and indications for use of the Fraxel SR Laser System are similar to those of the cited predicate laser devices. These devices are equivalent in terms of design, materials, principal of operation, and product specifications. Any differences between the Reliant Technologies Laser System II and the predicate devices do not raise new issues regarding safety or effectiveness.

Clinical Performance Data

Results of peer-reviewed publications and clinical investigations were used to demonstrate that the Fraxel SR Laser System functioned as clinically intended. Sufficient data have been gathered from clinical studies to determine that the Fraxel SR Laser System performs as clinically intended and that no new issues of safety and effectiveness are introduced.

Conclusion

ત્વની સ

Based on the design, materials, function, intended use, and clinical evaluation, the Reliant Technologies Laser System II is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the Reliant Technologies Laser System II raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 5 - 2005

Ms. Heather Tanner Clinical and Regulatory Affairs Reliant Technologies Incorporated 260 Sheridan Avenue, Suite 300 Palo Alto, California 94306

Re: K050841

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: March 31, 2005 Received: April 14, 2005

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 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 - Ms. Heather Tanner

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 Sovall 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/industry/support/index.html.

Sincerely yours.

Eue A. Mann, M

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

510(k) Number:

150841

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), melasma and dyschromia;

Skin resurfacing procedures."

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ ﺳﮯ (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

Division Sign-off Division of General, Restorative and Neurological Devices

510(k) Number

Signature

101 Sign-Off) vision of General, Restorative 1d Neurological Devices

KOS0841

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.