· 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.

· In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea.

· In patients undergoing ophthalmic surgery or other treatment requiring pocket cuts/incisions in the cornea.

Device Description

The WaveLight® FS200 is a stationary scanning-spot femtosecond laser system used to support refractive surgery of the cornea as specified in the indications for use statement.

AI/ML Overview

The provided text is a 510(k) summary for the WaveLight FS200 Laser System, which is an ophthalmic laser. It focuses on demonstrating substantial equivalence to predicate devices for new indications for use related to arcuate and pocket cuts/incisions in the cornea. It is not a study proving device meeting specific acceptance criteria in the context of an AI/algorithm-driven device with performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested categories for a study proving device acceptance criteria (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission. This document describes a traditional medical device's non-clinical performance and a comparison to predicate devices, not an AI/ML device study.

However, I can extract the relevant information regarding performance testing and a high-level "acceptance criteria" through the lens of what this document does provide.

Here's the breakdown based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy, precision, and quality of arcuate corneal cuts/incisions	"The results of these tests showed that the achieved performance is consistent with the requirements for these indications." (Specific numerical values for accuracy, precision, or quality are NOT provided in this summary.)
Accuracy, precision, and quality of corneal pocket cuts/incisions	"The results of these tests showed that the achieved performance is consistent with the requirements for these indications." (Specific numerical values for accuracy, precision, or quality are NOT provided in this summary.)
Safety Standards Compliance	"The WaveLight® FS200 Laser System has undergone testing and is in compliance with the applicable safety standards."
Substantial Equivalence to Predicate Devices	The technology, design principle, and mode of operation of the WaveLight® FS200 were found to be "fundamentally the same as the cleared predicate devices" regarding laser radiation (wavelength, duration, femtosecond pulses for photo disruption) and patient contact portion fixation (sterile, disposable suction rings and patient interfaces). The new indications (arcuate and pocket cuts) were also deemed "very similar" to cleared predicate indications.

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

Sample Size for Test Set: The document states "Performance testing on pig eyes." It does not specify the number of pig eyes used.
Data Provenance: The data is from "pig eyes," indicating an ex vivo or in vivo animal study, not human data. The country of origin is not specified. It is a non-clinical study, presumably prospective in design for the purpose of testing the device.

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

Experts: Not applicable. This document describes non-clinical performance testing on animal tissue (pig eyes) to demonstrate the physical properties of the cuts. The "ground truth" would be objective measurements of the cuts themselves, not expert interpretation of images or clinical outcomes.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. As this is non-clinical testing of physical device output on animal tissue, an adjudication method for human interpretation is not relevant.

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:

MRMC Study: No, an MRMC study was not done. This device is an ophthalmic surgical laser, not an AI/ML-powered diagnostic or assistive tool for human interpretation.

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

Standalone Performance: Not applicable in the context of an AI algorithm. The device is a standalone surgical laser. Its performance (accuracy, precision, quality of cuts) was assessed directly from its physical output.

7. The type of ground truth used:

Ground Truth: For the non-clinical performance testing, the ground truth would be objective measurements of the arcuate and pocket cuts/incisions (e.g., dimensions, morphology, depth, width, curvature) produced by the laser on the pig eyes. The document states "accuracy, precision, and quality" were addressed, implying quantitative measurement of these physical parameters.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This summary describes a physical medical device, not an AI/ML algorithm that requires a training set. The device itself is "trained" through its engineering design and manufacturing processes.

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

Training Set Ground Truth: Not applicable. As there is no AI/ML algorithm involved, there is no training set and therefore no ground truth establishment for a training set.

Summary

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Image /page/0/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 three human profiles facing right, with flowing lines above them that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

September 30, 2014

Alcon Laboratories, Inc. % Mr. Bob Lundberg Vice President, VGR, Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134

Re: K141476

Trade/Device Name: Wavelight FS200 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: August 25, 2014 Received: August 29, 2014

Dear Mr. Lundberg:

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.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander - S

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

Enclosure

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Indications for Use

510(k) Number (if known) K141476

Device Name Wavelight FS200

Indications for Use (Describe)

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 treatment reguiring 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.

· In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea.

· In patients undergoing ophthalmic surgery or other treatment requiring pocket cuts/incisions in the cornea."

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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:

Amy Tezel, PhD Director, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134 Phone: (817) 568-6189 Fax: (817) 551-4630

Date Summary Prepared: June 3, 2014

Device Subject to this 510(k):

Trade Name:	WaveLight® FS200 Laser System
Common Name:	Femtosecond Laser
Classification Name:	Class II886.4390 - Ophthalmic laser
Product Code:	OOE - Ophthalmic Femtosecond Laser

Predicate Devices: 5.1

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

510(k) Number	Device
K131207	FEMTO LDV Z6
K113151	iFS Laser System
K101006 andK121031	WaveLight® FS200 Laser System

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A side by side comparison of the technology, design principle and mode of operation of the WaveLight® FS200 to the identified predicate devices demonstrates that they are substantially equivalent. All of these devices use laser radiation of similar wavelength and duration (femtosecond pulses) in order to produce a controlled pattern of photo disruption to create cuts/separation in ophthalmic tissue.

The means of fixation of the patient contact portion through sterile and disposable suction rings and patient interfaces is also substantially equivalent to the cleared predicate devices.

Looking at the proposed new indications for use, the arcuate cuts/incisions statement is very similar to the cleared indications for use of all the listed predicate devices; the pocket cuts/incisions statement is very similar to the cleared indications of the main predicate device, the "FEMTO LDV Z6 Femtosecond Surgical Laser".

Since the initial 510(k) submission (K101006) of the WaveLight® FS200 where substantial equivalence to the Intralase iFS Laser System was demonstrated, the WaveLight® FS200 has been categorized under the same regulation number and product code as the Intralase iFS Laser System (21 CFR 878.4810; GEX).

Device Description: 5.2

The WaveLight® FS200 is a stationary scanning-spot femtosecond laser system used to support refractive surgery of the cornea as specified in the indications for use statement.

5.3 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.

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In patients undergoing ophthalmic surgery or other treatment requiring arcuate . cuts/incisions in the cornea.
In patients undergoing ophthalmic surgery or other treatment requiring pocket . cuts/incisions in the cornea.

Brief Summary of Nonclinical Test and Results: 5.4

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

Performance testing on pig eyes addressed the accuracy, precision, and quality of the arcuate corneal cuts/incisions and corneal pocket cuts/incisions produced by the WaveLight® FS200. The results of these tests showed that the achieved performance is consistent with the requirements for these indications.

The comparison with the predicate devices gives evidence that the technology, design principle and mode of operation of the WaveLight® FS200 are fundamentally the same as the cleared predicate devices. All of these devices use laser radiation of similar wavelength and duration (femtosecond pulses) in order to produce a controlled pattern of photo disruption to create cuts/separation in ophthalmic tissue.

The means of fixation of the patient contact portion through sterile and disposable suction rings and patient interfaces is also substantially equivalent to the cleared predicate devices.

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.