The XTRAC XL2 Excimer Laser System Model AL8000 is a complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic operater services ann. The laser system consists of a touch-screen display, an advanced fiberoptic cable attached to a handpiece, and a foot-switch to initiate exposure. The laser is enclosed in a protective interlocked housing. The unit is designed to operate on standard AC power available from wall outlets and can accommodate US, European and other nominal supply voltages and operating frequencies.

AI/ML Overview

The provided 510(k) summary for the PhotoMedex XTRAC XL2 Excimer Laser System, Model AL8000, does not contain the type of acceptance criteria and study information typically associated with AI/ML device evaluations. This document is for an excimer laser system for dermatological conditions and its clearance is based on substantial equivalence to previously cleared predicate devices, rather than new clinical performance data demonstrating device performance against specific acceptance criteria.

Therefore, many of the requested sections below cannot be filled from the provided text, as the document focuses on regulatory clearance for a hardware device, not an AI/ML algorithm.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

Acceptance Criteria and Device Performance Study (XTRAC XL2 Excimer Laser System)

This 510(k) submission for the XTRAC XL2 Excimer Laser System, Model AL8000, evaluates its substantial equivalence to previously cleared excimer laser systems for dermatological phototherapy. The submission does not present new clinical data against specific performance acceptance criteria for the device itself, but rather relies on the established safety and effectiveness of its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is for a medical device (laser system), not an AI/ML diagnostic or prognostic tool. Therefore, standard AI/ML performance metrics (sensitivity, specificity, AUC, etc.) and associated acceptance criteria are not applicable or mentioned. The "acceptance criteria" here relate to meeting safety standards and demonstrating equivalence to predicate devices, which is largely qualitative in the provided summary.

Acceptance Criterion (Implicit from 510(k) process)	Reported Device Performance (based on substantial equivalence)
Safety and Effectiveness Equivalence: No new issues of safety or efficiency compared to predicates.	The device performs in an identical manner as the identified predicates, and differences (size, weight, ergonomics, enhanced operating parameters, maintenance improvements) do not affect safety or intended use.
Intended Use Equivalence: Identical intended use.	Intended use (targeted UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma) is identical to predicate devices.
**Technological Characteristics Equivalence (or
differences do not raise new questions of safety/effectiveness):** Monochromatic (308nm) UVB light generation and therapeutic mechanism.	The device is a "complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic wavelength (308nm)." This mechanism is identical to the predicates.
Compliance with Standards: Meets relevant electrical safety, performance, and risk management standards.	Complies with current applicable international EN 60601 series of standards, 21 CFR Part 1040.10 & 1040.11 Performance Standards for Light-Emitting Products, UL 2601-1/UL60601-1, and EN ISO 1497 (risk management).

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

No new clinical test set data was used or presented for this 510(k) submission, as the clearance is based on substantial equivalence. The document explicitly states: "PhotoMedex believes duplicative clinical data is not required as a condition of granting market clearance for the XTRAC XL2 Excimer Laser System Model AL8000."

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

Not applicable. No new clinical test set was used.

4. Adjudication method for the test set

Not applicable. No new clinical test set was used.

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

Not applicable. This device is an excimer laser system, not an AI/ML diagnostic tool, and no MRMC study was conducted or presented.

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

Not applicable. This device is an excimer laser system, not an AI/ML algorithm.

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

Not applicable, as no new clinical data was collected or analyzed for ground truth in this submission. The "ground truth" for the device's efficacy is based on the previously cleared predicate devices and the established understanding of UVB phototherapy for the indicated conditions.

8. The sample size for the training set

Not applicable. This document is for a hardware device clearance via substantial equivalence, not an AI/ML training set.

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

Not applicable. This document is for a hardware device clearance via substantial equivalence, not an AI/ML training set.

Summary

{0}------------------------------------------------

K041943

510(k) SUMMARY PhotoMedex, Inc. XTRAC XL2 Excimer Laser System, Model AL8000

1. GENERAL

• Submitter:	PhotoMedex, Inc.2431 Impala DriveCarlsbad, CA 92008
--------------	-------------------------------------------------------------

Bob Rose ● Contact Person:
July 16, 2004 Date Prepared: .

2. DEVICE NAME

Laser surgical instrument for use in general and plastic Classification name: . surgery and in dermatology (21 CFR §878.4810)
Common or usual name: XeCl excimer laser .
Trade or proprietary name: XTRAC XL2 Excimer Laser System, Model AL8000 .

3. PREDICATE DEVICES

Excimer Laser

Excimer Laser Phototherapy System, model AL7000, AccuLase . (PhotoMedex), cleared via 510(k) K992914
XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared . via 510(k) K003705
XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared . via 510(k) K011382
XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared . via 510(k) K020847
XTRAC XL Plus Excimer Laser System. Model AL7000, PhotoMedex, Inc. . cleared via 510(k) K031451

{1}------------------------------------------------

4. DEVICE DESCRIPTION

5. INTENDED USE

The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.

6. SUBSTANTIAL EQUIVALENCE

The application of the Excimer Laser phototherapy has been proven to be substantially equivalent to current legally marketed devices in the treatment of indications previously cleared by CDRH (ODE). PhotoMedex has been granted mercently provised 1 1 K003705, K011382, K020847, and K031451 for this method of phototherapy generation.

The intended use for the PhotoMedex XTRAC XL2 Excimer Laser System, Model AL8000, and the identified predicate devices are identical in that they are all excimer lasers used to produce monochromatic (308nm) UVB light for the purpose of targeted, dose controlled UVB (dermatological) phototherapy. The differences between the XTRAC XL2 Excimer Laser System Model AL8000, and the identified predicates are limited to a reduction in product size and weight, improved ergonomics for the user, enhanced operating parameters, and additional minor internal improvements to reduce (required) maintenance costs. We believe the inclusion of these features does not affect the device's safety or intended use as compared to the identified predicates.

7. CLINICAL PERFORMANCE TESTING

All clinical indications requested in this application have been previously cleared in the identified predicate devices. The XTRAC XL2 Excimer Laser System Model AL8000 does not introduce any new indications for use, and will perform in an identical manner as the identified predicates, therefore PhotoMedex believes duplicative clinical data is not required as a condition of granting market clearance for the XTRAC XL2 Excimer Laser System Model AL8000.

{2}------------------------------------------------

8. PRODUCT PERFORMANCE TESTING

Testing and certification relevant to the XTRAC XL² Excimer Laser System Model I coung and certificance to current applicable international EN 60601 series of standards, 21 CFR Part 1040.10 & 1040.11 Performance Standards for Light-Emitting Products and also includes UL 2601-1/UL60601-1 Medical Electrical Equipment classified device. Products are produced and distributed within a facility that has been registered by FDA to manufacture medical devices. The XTRAC XL2 Excimer Laser System Model AL8000 also is reviewed for risk management utilizing EN ISO 1497, Application of risk management to medical devices ensuring all aspects of the device are reviewed for potential hazards.

9. CONCLUSIONS

PhotoMedex believes the XTRAC XL² Excimer Laser System Model AL8000 is substantially equivalent to the identified predicates in that it does not introduce any new issues of safety or efficiency as compared to the predicates. The Indications for use, methods of operation and power source is identical to the predicate.

{3}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The symbol is composed of three curved lines that create a sense of movement and dynamism.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 2004

Mr. Bob Rose Director of Regulatory Affairs and Quality Assurance PhotoMedex, Inc. 2431 Impala Drive Carlsbad, California 92008

Re: K041943

K041743
Trade/Device Name: XTRAC XL2 Excimer Laser System Model AL8000 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: July 16, 2004

Dear Mr. Rose:

Received: July 19, 2004

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications ferenced above and have acterimed ally marketed predicate devices marketed in interstate for use stated in the encreate) (c 10gars) the enactment date of the Medical Device Amendments, or to comments prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alla Costience Act (110) that do november to the general controls provisions of the Act. The 1 ou may, merciole, market the do received, courements for annual registration, listing of general controls provisions of viactice, 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 (600 world). Existing major regulations affecting your device can thay be subject to such additions, 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 I Toast oc advised that I Dr o restion that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any I caetar statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF N Fart 877), Morellans (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - Mr. Bob Rose

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin marketing your aceries of your device to a legally premarket notification. The PDA midning of castification 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 acritorior your as (240) 276-0115. Also, please note the regulation entitled, a conlact the Office of Complance at (21 t m = (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on your response 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 vours,

Mark N. Milliken

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

{5}------------------------------------------------

Indications for Use

K 041943 510(k) Number (if known):

XTRAC XL² Excimer Laser System Model AL8000 Device Name:

Indications For Use:

UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma

Mahh N. Millerm

Division of General, Restorative, and Neurological Devices

510(k) Number K041943

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)

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.