Benign Vascular Lesions Port Wine Stains Erythrosis Couperosis Facial Telangiectasias Leg Veins - Micro-varicosities Benign Pigmented Lesions Senile Lentigo
The examples are not intended to be exhaustive or complete but-to serve as a general guide to surgeons.

Device Description

The COSMOS Medical Technology COMPACT KTP laser emits a beam of coherent light at 532 nanometers as do the predicate devices.

AI/ML Overview

The provided document describes a 510(k) summary for the COSMOS Medical Technology COMPACT KTP laser. It does not contain information about acceptance criteria or a dedicated study proving device performance in the way typically expected for medical device evaluations that involve quantitative performance metrics, such as accuracy, sensitivity, or specificity.

Instead, the submission relies on substantial equivalence to predicate devices. This means that performance data were not required because the specifications and indications for use of the COSMOS Medical Technology COMPACT KTP laser were deemed "the same or very similar" to those of legally marketed predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable to this specific submission.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified for quantitative performance metrics. The underlying acceptance criterion for this 510(k) was substantial equivalence to predicate devices in terms of specifications and indications for use.	The device's specifications (e.g., emits a beam of coherent light at 532 nanometers) and indications for use (coagulation, ablation, vaporization, incision, excision, or cutting of soft tissue in dermatology) were found to be the same as or very similar to the predicate devices. This similarity was considered sufficient to establish substantial equivalence without new performance data.

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

Not Applicable. No dedicated test set or study validating the device's performance against specific metrics was conducted or reported in this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate devices.

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

Not Applicable. As no test set with ground truth was established for this device's performance evaluation, this information is not relevant.

4. Adjudication method for the test set

Not Applicable. No adjudication method was employed for a test set as no such study was conducted for this 510(k) submission.

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 a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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

Not Applicable. This device is a physical laser instrument for surgical procedures, not a software algorithm.

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

Not Applicable. No specific ground truth was used for performance validation of this device, as its substantial equivalence was based on comparison to predicate devices, not on new performance data demonstrating accuracy against a ground truth.

8. The sample size for the training set

Not Applicable. This 510(k) submission does not describe a machine learning algorithm that requires a training set.

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

Not Applicable. This 510(k) submission does not describe a machine learning algorithm; therefore, a training set and its associated ground truth are not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is a comparative analysis of specifications and indications for use against legally marketed predicate devices. The document states:

"The specifications of and indications for the COSMOS Medical Technology COMPACT KTP laser are the same as or very similar to those of the claimed predicates."
"Because of this, performance data were not required."
Conclusion: "Based on the similarities of specifications and indications for use, COSMOS Medical Technology believes that the COMPACT KTP laser described in this notification is substantially equivalent to the cited legally marketed predicate devices."

The FDA, through the letter dated November 25, 1998, concurred with this assessment, stating, "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Therefore, the "proof" is the demonstration of substantial equivalence through a direct comparison with existing, legally marketed devices, rather than a prospective study with quantitative performance metrics.

Summary

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983020

APPENDIX E

510(k) SUMMARY COSMOS MEDICAL TECHNOLOGY COMPACT KTP LASER

This 510(k) summary of-safety-and-effectiveness-for the-COSMOS Medical Technology COMPACT KTP laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant:	COSMOS-Medical Technology
Address:	P.O. Box 27210San Diego, CA 92198
Manufacturer:	Crystal Focus, S.A.19 Rue Ampere, BP 3591302 Massy, France(011) +33-1-6920-8454-(011) +33 1 6981 7639 (Fax)
Preparation Date:(of the Summary)	August 1998
Device Name:	COMPACT KTP laser
Common Name:	Frequency doubled Nd: YAG laser
Classification Name:	Laser surgical instrument for use in general and plastic surgery and indermatology21 CFR 878.4810).Product Code: GEX.Panel: 79
Legally marketedpredicate device:	Laserscope Aura Laser System; American Laser Medical NovuLase 660Laser System; and Laserscope KTP/532 and KTY/YAG-lasers,.
Device description:	The COSMOS Medical Technology COMPACT KTP laser emits a beamof coherent light at 532 nanometers as do the predicate devices.
Indications for use:	The COSMOS Medical Technology COMPACT KTP laser is intended forthe coagulation, ablation, vaporization, incision, vaporization, incision,excision, or cutting of soft tissue in dermatology

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Comparisons: The specifications of and indications for the -COSMOS Medical Technology COMPAET KTP laser are the same as or very similar to those of the claimed predicates. None. The specifications and indications for use of the COSMOS Performance Data: Medical Technology COMPACT KTP laser are the same or very similar to those of the claimed predicate devices. Because of this, performance data were not required. CONCEUSION: Based- on the similarities of specifications and-indications-for-use, COSMOS Medical Technology believes that the COMPACT KTP laser described in this notification is substantially equivalent to the cited legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three lines representing the body, head, and arm. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 25 1308

Mr. John P. Clark President COSMOS Medical Technology P.O. Box 27210 San Diego, California 92198

Re: K983020 Trade Name: COMPACT KTP Laser Regulatory Class: II Product Code: GEX Dated: August 27, 1998 Received: August 31, 1998

Dear Mr. Clark:

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 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). 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 requirements, as set forth in the Quality System Regulation (OS) 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.

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Page 2 - Mr. John P. Clark

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 predicate device results in a classification for your device and thus, permits vour 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/dsma/dsmamain.html".

Sincerely yours,

toscello

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX B

INDICATIONS FOR USE STATEMENT

rg83020 510(K) Number (if known) : _

Device Name: COSMOS Medical Technology COMPACT KTP Laser

Indications For Use Statement:

The COMPACT-KTP-laser-is-intended-for-the-coagulation, ablation- vaporization, incision, excision, and/or cutting of soft tissue in dermatology.

Examples of applications include:

Benign Vascular Lesions Port Wine Stains Erythrosis Couperosis Facial Telangiectasias Leg Veins - Micro-varicosities Benign Pigmented Lesions Senile Lentigo
The examples are not intended to be exhaustive or complete but-to serve as a general guide to surgeons.

Labeling in the draft manual restricts the COMPACT KTP laser to prescription use (see page 13 of the draft manual - APPENDIX A).

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)

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.