· In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
· In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty.
· In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.

Device Description

The WaveLight® FS200 Laser System is a stationary scanning-spot femtosecond laser system used in refractive surgery.

AI/ML Overview

The provided text describes the WaveLight® FS200 Laser System and its clearance through the 510(k) pathway. However, the document does not contain a detailed study design with specific acceptance criteria, sample sizes for test and training sets, expert qualifications, or adjudication methods in the way one would typically expect for a modern AI/ML device submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance in creating corneal cuts. The information provided is characteristic of a traditional medical device submission rather than one for an AI/ML diagnostic tool.

Here's an attempt to answer your questions based only on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for precise numerical metrics like accuracy, sensitivity, or specificity. Instead, it refers to "performance tests" that establish "equivalence" to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Performance of cuts is equivalent to predicate laser systems and microkeratomes for various corneal procedures.	The WaveLight® FS200 Laser System and accessory Patient Interface were found to perform equivalently to the predicate laser and microkeratome and their patient interfaces for the creation of corneal cuts.
Compliance with applicable safety standards.	The WaveLight® FS200 Laser System has undergone testing and is in compliance with the applicable safety standards.

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

The document states: "Performance tests according to the FDA Guidance 'Keratome and Replacement Keratome Blades Premarket Notification [(510(k)] Submissions' were conducted to collect data on the accuracy, precision and quality of the cuts achieved with the WaveLight® FS200 Laser System."

Test Set Sample Size: Not specified. The document does not provide a number for the test set.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not applicable/Not specified. The "ground truth" here would relate to direct measurements of the physical cuts, not expert interpretation of outputs. The document does not mention the use of experts in this context.

4. Adjudication method for the test set

Not applicable/Not specified. Given the nature of a laser system creating physical cuts, an adjudication method for expert consensus on images is not relevant to the described performance tests.

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 not an AI/ML device that assists human readers. It's a surgical instrument.

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

The device is a standalone surgical laser system. Its performance evaluation focuses on the quality of the cuts it creates.

7. The type of ground truth used

The "ground truth" would be objective measurements of the physical characteristics (accuracy, precision, quality) of the corneal cuts themselves, likely performed using metrology or other analytical techniques directly on the cut tissue, as described in the referenced FDA Guidance. The document doesn't explicitly detail the methodology, but for a keratom, ground truth typically involves physical measurements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary Limitations:

The provided 510(k) summary is for a traditional surgical laser system, not an AI/ML driven device. Therefore, many of the questions related to AI/ML specific evaluation criteria (like training sets, expert consensus, MRMC studies, etc.) are not addressed in the document and are likely not relevant to its regulatory clearance. The performance testing for this device would have focused on engineering specifications, safety, and the physical outcomes of the laser's operation compared to known predicate devices or established standards.

Summary

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WaveLight® FS200 Laser System

OCT 2 1 2010

K10joo6

5. 510(K) SUMMARY

510(k) Summary

This summary document is being prepared in accordance with section 21 CFR 807.92(c).

The submitter of the 510(k) is:

Michael Buenger Associate Director, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134 Phone: (817) 551-6810 Fax: (817) 551-4630

Date Summary Revised: September 30, 2010

Device Subject to this 510(k):

WaveLight® FS200 Laser System Trade Name: Common Name: Laser Powered Laser Surgical Instrument Classification Name:

1. Predicate Devices:

The legally marketed device(s) to which we are claiming substantial equivalence are:

510(k) Number	Device
K060372	FS Laser System
K032910	Carriazo Pendular Keratom
K073404	iFS Laser System

2. Device Description:

The WaveLight® FS200 Laser System is a stationary scanning-spot femtosecond laser system used in refractive surgery.

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WaveLight® FS200 Laser System

3. Indications for Use:

Indications for Use:

The WaveLight® FS200 Laser System is an ophthalmic surgical laser indicated for use:

· In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
· In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty.
· In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.

4. Statement of how the Technological Characteristics of the Device compare to those of the Predicate or legally marketed Device

The technological characteristics of the WaveLight® FS200 Laser System are very similar to those of the predicate laser devices. The WaveLight® FS200 Laser System and the predicate laser devices are femtosecond lasers which work in the same mode at similar frequencies with similar spot sizes. The WaveLight® FS200 Laser System works at a slightly higher pulse repetition rate and shorter pulse duration. The WaveLight® FS200 Laser System and the predicate laser devices use similar common materials and the same energy source. Therefore, the technological characteristics of the WaveLight® FS200 Laser System are substantially equivalent those of the predicate laser devices cleared under K060372 and K073404. The technological characteristics of the WaveLight® FS200 Laser System and the Carriazo Pendular Keratome (K032910) are different in that the predicate device is a mechanical keratome. The Carriazo Pendular Keratome was used as a predicate device for the purpose of flap cutting comparison. The WaveLight® FS200 is considered as an alternative to mechanical microkeratomes.

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WaveLight® FS200 Laser System

5. Brief Summary of Nonclinical Test and Results:

The WaveLight® FS200 Laser System has undergone testing and is in compliance with the applicable safety standards.

Performance tests according to the FDA Guidance "Keratome and Replacement Keratome Blades Premarket Notification [(510(k)] Submissions'' were conducted to collect data on the accuracy, precision and quality of the cuts achieved with the WaveLight® FS200 Laser System .

The WaveLight® FS200 Laser System and the accessory Patient Interface were found to perform equivalently to the predicate laser and microkeratome and their patient interfaces for the creation of corneal cuts.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized symbol resembling three human figures connected at the arms, positioned to the right. Encircling this symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Alcon Research, Ltd. c/o Mr. Michael Buenger Associate Director, Regulatory Affairs 6201 South Freeway Forth Worth, TX 76134

OCT 2 1 2010

Re: K101006

Trade/Device Name: WaveLight® FS200 Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Powered Laser Surgical Instrument Regulatory Class: Class II Product Code: GEX, HNO Dated: October 1, 2010 Received: October 6, 2010

Dear Mr. Buenger:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kasia Alexander

Image /page/4/Picture/7 description: The image shows a handwritten word "for" in cursive, positioned to the left of three lines of text. The text on the right consists of the letters "M", "D", and "O", each followed by a colon. The text is vertically aligned, with the word "for" appearing to be an annotation or label associated with the text on the right.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KIDIOOG OCT 2-1-2010

WaveLight® FS200 Laser System

4. INDICATIONS FOR USE STATEMENT

510(k) Number: K101006

WaveLight® FS200 Laser System Device Name:

Indications for Use:

The WaveLight® FS200 Laser System is an ophthalmic surgical laser indicated for use:

· In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
· In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty.
· In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.

X Prescription Use _ AND/OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dr. Callan

Page 16 Of 1890

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

510(k) Number K101006

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.