LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) by LASERSCOPE

The Lyra™ Series Surgical Laser Systems are Nd: YAG lasers producing laser emission @ 1064nm. The Laserscope Lyra Surgical Laser System consists of four major subsystems: The Optical and Laser Resonator system; The Cooling system; The Electronics and Electrical system; The Operator interface.

AI/ML Overview

The provided text describes the Laserscope Lyra™ Surgical Laser System & Accessories 510(k) Premarket Notification. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria from an AI/algorithm perspective.

This document is a traditional medical device 510(k) summary for a physical laser system, not for a software or AI-driven diagnostic device. Therefore, the concepts of "test set," "ground truth," "MRMC study for AI improvement," and "standalone algorithm performance" are not applicable in the context of this specific regulatory submission.

Here's what can be extracted and what cannot:

Information from the provided text:

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

Acceptance Criteria: The document only broadly states that "Clinical studies produced results that indicate the Laserscope Lyra™ Laser Systems & Accessories is safe and effective for the treatment of facial wrinkles." Specific quantitative acceptance criteria (e.g., a certain percentage reduction in wrinkles, or a specific patient satisfaction score) are not provided.
Reported Device Performance: Similarly, specific performance metrics are not provided. The document only offers a general statement about safety and effectiveness.

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

Test Set Sample Size: Not provided.
Data Provenance: The document mentions "Clinical studies," implying prospective data collection on human subjects, but does not specify country of origin or whether it was retrospective.

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

This concept of "experts establishing ground truth" is typically associated with AI model validation where human experts label data. For a physical laser device for wrinkle treatment, the "ground truth" would likely be direct clinical observation by physicians, patient self-assessment, or possibly photographic analysis by a panel of evaluators. However, none of this detail is provided.

4. Adjudication method for the test set:

Not provided.

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 is a physical laser device, not an AI system being evaluated to assist human readers.

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

Not applicable. This is a physical laser device.

7. The type of ground truth used:

The document implies the ground truth was based on clinical outcomes relevant to "safety and effectiveness for the treatment of facial wrinkles." This would likely involve physician assessment, possibly patient questionnaires, and potentially photographic evidence, but specifics are not given. It is not pathology or genetic data.

8. The sample size for the training set:

Not applicable / not provided. The concept of a "training set" applies to machine learning models, not typically to the direct development and testing of a physical medical device. While there were clinical studies, they are not referred to as a "training set" in this context.

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

Not applicable / not provided.

In summary of what is available from the document:

Device Type: Laserscope Lyra™ Surgical Laser System & Accessories (Nd:YAG laser)
Intended Use: Dermatological applications for the treatment of facial wrinkles.
Performance Claim: "Clinical studies produced results that indicate the Laserscope Lyra™ Laser Systems & Accessories is safe and effective for the treatment of facial wrinkles."
Nonclinical Data: None mentioned for this specific submission, likely relying on prior predicate device data for engineering performance.
Clinical Data: Yes, clinical studies were performed to support safety and effectiveness. However, no details about the study design, sample size, specific endpoints, or results are included in this 510(k) summary.

This 510(k) summary serves to establish substantial equivalence to predicate devices, and as such, often omits the granular detail of clinical study results that would typically be found in a full clinical study report or a PMA submission requiring more extensive evidence.

Summary

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Laserscope Lyra™ Surgical Laser System & Accessories 510(k) Premarket Notification

510(k) Summary

KO20021

This 510(k) Summary of Safety & Effectiveness for the Laserscope's Lyra Surgical Laser System & Accessories is submitted in accordance with the requirements of SMDA 1990 and CFR 807.92 and CFR 807.93 follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

A.. Trade Name Lyra "M Surgical Laser System and Accessories (Nd: YAG configuration)
B. Common Name Laser Instrument, Surgical, Powered

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C. Establishment Registration Number 2937094
D. Manufacturer's Identification Laserscope 3070 Orchard Drive San Jose, CA 95134-2011 (408) 943-0636 (503) 961-1688 FAX

Official Correspondent Paul Hardiman Manager, Regulatory Affairs/Clinical Affairs

E. Device Classification The Lyra™ Series Surgical Laser System has been specifically classified as a Class II medical device by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels.
F. Performance Standards The Lyra™ Series Surgical Laser System conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
G. Device Description The Lyra™ Series Surgical Laser Systems are Nd: YAG lasers producing laser emission @ 1064nm. The Laserscope Lyra Surgical Laser System consists of four major subsystems:

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The Optical and Laser Resonator system; The Cooling system; The Electronics and Electrical system; The Operator interface.

G. Substantial Equivalence In the opinion of Laserscope, the Laserscope Lyra™ Surgical Laser System & Accessories is substantially equivalent in technology and intended use to the Lyra 1M Surgical Laser System FDA cleared under 510(k) K9990903, the CoolTouch Nd:YAG Laser System FDA cleared under 510(k) K003715, and the SLS NLite System FDA cleared under 510(k) K000811.
H. Indications For Use: The Laserscope Lyra™ Laser Systems & Accessories are indicated for use in the Dermatological applications for the treatment of facial wrinkles.
I. Nonclinical Performance Data: None.
J. Clinical Performance Data: Clinical studies produced results that indicate the Laserscope Lyra" Laser Systems & Accessories is safe and effective for the treatment of facial wrinkles.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure, with three faces in profile, suggesting a focus on people and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 2 2002

Laserscope Paul Hardiman Manager, Regulatory Affairs/Clinical Affairs 3070 Orchard Drive San Jose, California 95134-2011

Re: K020021

Trade Name: Lyra GTM Series Laser System and Accessories (Nd: YAG configuration) Regulation Number: 878.4810 Regulation Name: Laser surgical instrument, powered Regulatory Class: II Product Code: GEX Dated: April 11, 2002 Received: April 12, 2002

Dear Mr. Hardiman:

We have reviewed your Section 510(k) premarket 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) 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 - Mr. Paul Hardiman

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Hpt Ruvelu

Witten, Ph.D., M.D. 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 STATEMENT Page 1 of 1

510(k) Number:	K020021
Device Name:	LASERSCOPE LYRA TM SERIES SURGICALLASER SYSTEM & Accessories
Indications for Use:	The Laserscope Lyra TM Laser Systems & Accessories areindicated for use in the Dermatological applications for the

treatment of facial wrinkles.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (per 21 CFR 801.109)

Over-The-Counter-Use

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

KOZDOZI 510(k) Number --

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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.