. In patients undergoing surgery or other 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 lamellar keratoplasty and corneal harvesting;
In the creation of a corneal flap in patients undergoing LASIK surgery or other o treatment requiring initial lamellar resection of the cornea:
. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty.

Device Description

The IntraLase FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections and incisions. The cutting action of the IntraLase FS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

AI/ML Overview

The provided 510(k) summary for the IntraLase FS Laser (K060372) does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.

Instead, this 510(k) relies on demonstrating substantial equivalence to previously cleared predicate devices (K993153, K001211, K002890, K013941, K031960, K041893). The summary explicitly states:

"The IntraLase FS Laser has undergone testing and is in compliance with applicable safety standards."
"The IntraLase FS and the accessory IntraLase Patient Interface were found to perform equivalently to the predicate Laser for the creation of corneal resections with respect to incremental changes."
"Thus, the IntraLase FS Laser and the predicate device have similar safety, effectiveness and performance profiles."
"The changes made to the labeling do not alter the performance or indication of this device."

This means the submission's evidence for performance is based on the prior clearance and established safety/effectiveness of the predicate devices, rather than a new clinical study with defined acceptance criteria for this specific submission.

Therefore, many of your requested items about a standalone study, acceptance criteria, sample sizes, ground truth, and expert adjudication cannot be extracted from this document because such a study is not described.

However, based on the information available, here's what can be stated:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, etc.) for a new performance study are not provided in this 510(k). The primary "acceptance criterion" demonstrated is substantial equivalence to predicate devices. The reported "performance" is that it performs "equivalently" to the predicate in creating corneal resections with respect to incremental changes.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent safety to predicate device	Found to have "similar safety... profiles" to predicate Laser
Equivalent effectiveness to predicate device	Found to have "similar... effectiveness and performance profiles" to predicate Laser
Equivalent performance in creating corneal resections with respect to incremental changes	Found to "perform equivalently to the predicate Laser for the creation of corneal resections with respect to incremental changes."

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

Test Set Sample Size: Not specified. The document refers to "testing" but does not detail the size or nature of any test set used in a clinical or performance study for this specific 510(k).
Data Provenance: Not specified.

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

Number of Experts: Not applicable, as detailed clinical efficacy data with expert ground truth is not provided.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Adjudication Method: Not applicable, as detailed clinical efficacy data with expert ground truth is 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:

MRMC Study: No. This device is a surgical laser, not an AI-assisted diagnostic device.

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

Standalone Study: The submission describes bench testing and compliance with safety standards and states the device performs "equivalently" to predicate devices. This implies non-clinical performance evaluation, but it's not a "standalone" clinical efficacy study as typically understood for diagnostic AI devices. The laser operates as a standalone surgical tool.

7. The type of ground truth used:

Type of Ground Truth: Not explicitly stated as "ground truth" in the context of clinical outcomes. The "equivalency" claim implies that the performance (e.g., quality of corneal resections) in non-clinical testing was assessed against established standards or performance of the predicate device.

8. The sample size for the training set:

Training Set Sample Size: 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:

Ground Truth for Training Set: Not applicable. This is not an AI/ML device that requires a training set and ground truth establishment.

Summary

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K060372

510(k) Summary 5 5 510(k) Summary AUG 16 2006 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a). SUMBITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY 5.1 PREPARED a. Applicant: IntraLase Corp. 9701Jeronimo Road Irvine, CA 92618 (949) 859-5230 Tel: Fax: (949) 330-0512 b. Contact Person: Charline Gauthier, OD, PhD Executive Vice President & Chief Operating Officer IntraLase Corp. (949) 859-5230 Tel: (949) 330-0512 Fax:

c. Date Summary Prepared February 7, 2006
5.2 NAME OF DEVICE, INCLUDING THE TRADE NAME AND CLASSIFICATION NAME:
a. Trade/Proprietary Name: IntraLase FS Laser
b. Common/Usual Name: Laser
c. Classification Name: Keratome
79 GEX d. Classification Code(s): 86 HNO

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5.3 IDENTIFICATION OF THE PREDICATE DEVICE OR LEGALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED:

510(k) #	Trade Name	Manufacturer
K993153	IntraLase 600C Laser Keratome	IntraLase Corp.
K001211	IntraLase 600C Laser Keratome	IntraLase Corp.
K002890	IntraLase 600C Laser Keratome	IntraLase Corp.
K013941	Pulsion FS Laser Keratome	IntraLase Corp.
K031960	IntraLase FS Laser	IntraLase Corp.
K041893	IntraLase FS Laser	IntraLase Corp.

5.4 A DESCRIPTION OF THE DEVICE THAT IS THE SUBJECT OF THE 510(K), INCLUDING EXPLANATION OF HOW THE DEVICE FUNCTIONS, BASIC SCIENTIFIC CONCEPTS, SIGNIFICANT PHYSICAL AND PERFORMANCE CHARACTERISTICS (DESIGN, MATERIAL, PHYSICAL PROPERTIES):

The IntraLase FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections and incisions.

The cutting action of the IntraLase FS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

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5.5 STATEMENT OF INTENDED USE:

The IntraLase® FS Laser is an ophthalmic surgical laser with the following indications for use:

In patients undergoing surgery or other 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 lamellar keratoplasty and corneal harvesting;
. In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea;
. In the creation of lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of penetrating cut/incision for penetrating keratoplasty.
STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARE TO 5.6 THOSE OF THE PREDICATE OF LEGALLY MARKETED DEVICE.

The technological characteristics of the IntraLase FS Laser have already been cleared under K041893, K031960, K013941, K002890, K001211 and K993153 for lamellar corneal resections and incisions. The changes made to the labeling do not alter the performance or indication of this device.

5.7 BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS:

The IntraLase FS Laser has undergone testing and is in compliance with applicable safety standards. The IntraLase FS and the accessory IntraLase Patient Interface were found to perform equivalently to the predicate Laser for the creation of corneal resections with respect to incremental changes. Thus, the IntraLase FS Laser and the predicate device have similar safety, effectiveness and performance profiles.

5

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

JAN 2 5 2011

Intralase Corporation c/o Charlene Gauthier, OD, Ph.D. Executive Vice President and Chief Operating Officer 9701 San Jeronimo Rd. Irvine, CA 92618

Re: K060372

Trade/Device Name: INTRALASE® FS Laser Model 1, Model 2 and the INTRALASE® FS30 Laser Model 3

Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Regulatory Class: II Product Code: GEX. HNO Dated: April 4, 2006 Received: April 7, 2006

Dear Dr. Gauthier:

This letter corrects our substantially equivalent letter of August 16, 2006.

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 (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 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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Page 2 - Charlene Gauthier, OD, Ph.D.

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 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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sincerely yours,
Kesia Alexander

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

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Indications for Use

510(k) Number (if known): K060372

Device Name(s): IntraLase FS Laser

Indications for Use:

The IntraLase® FS Laser is an ophthalmic surgical laser with the following indications for use:

. In patients undergoing surgery or other 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 lamellar keratoplasty and corneal harvesting; �
In the creation of a corneal flap in patients undergoing LASIK surgery or other o treatment requiring initial lamellar resection of the cornea:
. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Callaway

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K060372

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.