The Excimer Laser Phototherapy System, AL7000 is a complete self-contained compact laser light source, which utilizes a XeCl gas mixture to generate ultraviolet light at wavelength of 308 nm wavelength. The laser system consists of a keypad and display, a fiberoptic delivery system, a footswitch, and a handpiece. The laser is enclosed in a protective interlocked housing.

AI/ML Overview

The provided text describes the AccuLase, Inc. Excimer Laser Phototherapy System, AL7000, and its 510(k) submission. However, it does not provide detailed information about specific acceptance criteria or a study that explicitly proves the device meets those criteria with quantitative values.

Instead, it focuses on demonstrating substantial equivalence to predicate devices. Here's a breakdown based on the information available and what is not present:

Missing Information:

Specific quantitative acceptance criteria (e.g., "Psoriasis Area and Severity Index (PASI) score reduction of X% in Y% of patients").
Reported device performance against such criteria with numerical results.
Detailed methodology of any clinical study, including sample sizes, ground truth establishment for the test set, expert qualifications, adjudication methods, or specific study designs (MRMC, standalone).

Based on the provided text, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied by the text)	Reported Device Performance
Safety: Device is safe for use in UVB phototherapy for psoriasis.	"A dose response study using a 308 nm excimer laser showed the safety... of the excimer laser for the treatment of Psoriasis." (No specific metrics or thresholds reported)
Effectiveness: Device is effective for UVB phototherapy for psoriasis.	"A dose response study using a 308 nm excimer laser showed the... effectiveness of the excimer laser for the treatment of Psoriasis." (No specific metrics or thresholds reported)
Technological Equivalence: Produces ultraviolet light at 308 nm wavelength, similar operating principles to predicate excimer lasers.	"The Excimer Laser Phototherapy System is substantially equivalent to the technological characteristics of the predicate excimer laser device. Both devices share the same operating principles and produce an identical wavelength." (Stated as a qualitative finding of equivalence, not a direct performance measure)
Conformance to Standards: Conforms to relevant International EN 60601 / IEC 601 series and applicable laser standards.	"Testing conducted on the Excimer Laser Phototherapy System, AL7000 includes conformance to all relevant International EN 60601 / IEC 601 series of standards and applicable laser standards." (Stated as a qualitative fact, no specific test results provided)

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

Test Set Sample Size: Not specified. The text mentions "A dose response study" but does not provide details on the number of subjects or cases included.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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 text. The study mentioned is a "dose response study," which typically involves clinical observation and measurement by medical professionals rather than a consensus of experts adjudicating an output.

4. Adjudication method for the test set

This information is not provided as the nature of the study (dose response) doesn't typically involve adjudication of diagnostic outputs in the way an AI algorithm assessment would.

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 was not an MRMC comparative effectiveness study involving AI. The device is a laser phototherapy system, not an AI diagnostic tool that assists human readers.

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

This question is not applicable as the device is a medical device (laser system) for treatment, not an algorithm.

7. The type of ground truth used

For the "dose response study," the ground truth would implicitly be clinical outcomes/patient response to treatment, likely assessed by clinicians (e.g., improvement in psoriasis severity, reduction in lesion size/number). The text doesn't explicitly state "pathology" but clinical assessment of psoriasis would be the primary basis.

8. The sample size for the training set

This information is not applicable as the device is not an AI/machine learning algorithm requiring a training set.

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

This information is not applicable as the device is not an AI/machine learning algorithm.

Summary of what is present:

The 510(k) submission for the AccuLase AL7000 relies on demonstrating substantial equivalence to predicate devices: existing UV lamps for intended use and another excimer laser for technological characteristics. It mentions a "dose response study" that "showed the safety and effectiveness" for psoriasis treatment, but provides no quantitative details on this study, its design, sample size, or specific outcomes. Technical testing for conformance to safety standards (EN 60601 / IEC 601) was also performed. The document primarily focuses on regulatory compliance and equivalence rather than detailed clinical performance metrics typical of, for example, a diagnostic AI device requiring extensive ground truth validation.

Summary

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

JAN 27 2000

K 992914

510(k) SUMMARY AccuLase, Inc. Excimer Laser Phototherapy System, AL7000

1. GENERAL

. Submitter : AccuLase, Inc. 2431 Impala Drive Carlsbad, CA 92008
Contact Person: Al Memmolo .
Dute Prepared: January 14, 1999 .

2. DEVICE NAME

. Classification nume: Ultraviolet lamp for dermatological disorders (ner 21 CFR 8878.4630)
Common or usual name: XeCl excimer laser .
. Trade or proprietary name: Excimer Laser Phototherapy System, AL7000

3. PREDICATE DEVICES

Ultraviolet Lamps

HOUVA II, Phototherapy System . National Biological Corporation 510(k) number: K885026
UviSol, Phototherapy System . National Biological Corporation, 510(k) number K934808

Excimer Laser

CVX-300 Excimer Laser System . Spectranetics Corp. PMA number: P910001

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

510 (k) Summary AL 7000

4. DEVICE DESCRIPTION

5. INTENDED USE

UVB phototherapy for Psoriasis

6. SUBSTANTIAL EQUIVALENCE

The intended use for the AccuLase Excimer Laser Phototherapy System, AL.7000 is identical to that of the predicate ultraviolet lamps. Both device types share the same methods and mechanisms of treatment.

The Excimer Laser Phototherapy System is substantially equivalent to the technological characteristics of the predicate excimer laser device. Both devices share the same operating principles and produce un identical wavelength.

7. CI.INICAL PERFORMANCE DATA

A dose response study using a 308 nm excimer laser showed the safety and effectiveness of the excimer laser for the treatment of Psoriasis.

8. PRODUCT PERFORMANCE TESTING

Testing conducted on the Excimer Laser Phototherapy System, AL7000 includes conformance to all relevant International EN 60601 / IEC 601 series of standards and applicable laser standards.

9. CONCLUSIONS

Based on the same intended use as ultraviolet lamps, the similar technological characteristics of the excimer lasers, and the clinical and performance data, AccuLase believes that the Excimer Laser Phototherapy System, AL7000 is substantially equivalent to the predicate devices.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 2000

Mr. Al Memmolo Director, Quality Assurance and Regulatory Affairs AccuLase, Inc. 2431 Impala Drive Carlsbad, California 92008

Re: K992914

Trade Name: Excimer Laser Phototherapy System, AL 7000 Regulatory Class: II Product Code: GEX Dated: November 24, 1999 Received: November 29, 1999

Dear Mr. Memmolo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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

Page 2 - Mr. Al Memmolo

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

poella

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

AccuLase, Inc. ( a subsidiary of Laser Photonics, Inc.)

K992914

510(k) Number (if known):

Device Name:

Excimer Laser Phototherapy, AL 7000

Indications For Use:

UVB Phototherapy for Psoriasis

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
--	--------------------------------------------------------

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K992914

Prescription Use	X	OR	Over-The-Counter-Use
(Per 21 CFR 801.109)

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.