The IntraLase Fusion™ Laser is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Device Description

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

AI/ML Overview

The provided text describes a 510(k) summary for the IntraLase Fusion Laser, claiming substantial equivalence to a predicate device (IntraLase FS Laser, K060372). The document focuses on regulatory approval rather than a detailed study evaluating the device's performance against specific acceptance criteria.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, and performance metrics cannot be found in the provided text.

Here is an attempt to answer the questions based on the available information:

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

Acceptance Criteria	Reported Device Performance
Implicit Acceptance Criteria:	The IntraLase Fusion Laser and the accessory IntraLase Fusion Patient Interface were found to perform equivalently to the predicate laser and patient interface for the creation of corneal resections.
Compliance with applicable safety standards.	The IntraLase Fusion Laser has undergone testing and is in compliance with applicable safety standards.

Explanation: The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device. The primary "performance" reported is that the device "perform[s] equivalently" to the predicate for its intended use. Safety compliance is also mentioned as met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text mentions "nonclinical tests" but does not detail the methodology, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As a substantial equivalence submission for a surgical laser, ground truth typically would involve physical and operational testing rather than expert-derived ground truth for diagnostic image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not done. This device is a surgical laser, not an AI-powered diagnostic tool. The document describes non-clinical testing for equivalence to a predicate device.

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

This information is not provided related to "algorithm only" performance. The product is a physical laser device, not a standalone algorithm. The non-clinical tests would have evaluated the device's physical performance characteristics.

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

The document primarily refers to "nonclinical tests and results" which assessed whether the device "perform[s] equivalently to the predicate laser and patient interface for the creation of corneal resections" and its compliance with "applicable safety standards." The "ground truth" here would likely be objective measurements and observations of the physical characteristics and cutting performance of the laser, compared against the known characteristics and performance of the predicate device, rather than a diagnostic "ground truth" like pathology or expert consensus on an image.

8. The sample size for the training set

This information is not provided in the document. The concept of a "training set" is usually applicable to machine learning models, which is not the primary focus of this device's approval process based on the provided text.

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

This information is not provided in the document, as the device is not an AI/ML product for which a training set and its ground truth establishment would be discussed in this context.

Summary

{0}------------------------------------------------

9 2007 FER

510(K) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).

SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED:

IntraLase Corp. Applicant: વ. 9701 Jeronimo Road Irvine, CA 92618 Tel: (949) 859-5230 Fax: (949) 583-9557 Betty Johnson Contact Person: ﻓ
...
IntraLase Corp. 9701 Jeronimo Road Irvine, CA 92618 Tel: (949) 859-5230 Fax: (949) 583-9557 biohnson@intralase.com
c. Date of Summary Preparation February 1, 2007

NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME:

Trade/Proprietary Name:	IntraLase Fusion Laser
Common/Usual Name:	Laser
Classification Name:	Keratome
Classification Code(s):	79 GEX, 86 HNO

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

510(k) #	Trade Name	Manufacturer
K060372	IntraLase FS Laser	IntraLase Corp.

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):

(02/01/2007) K063682 of ನ್ನೆ ಮತ್ತು

{1}------------------------------------------------

ultrashort pulses which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.

STATEMENT OF INTENDED USE:

STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARE TO THOSE OF THE PREDICATE OR LEGALLY MARKETED DEVICE:

The technological characteristics of the IntraLase Fusion Laser have are substantially equivalent to those cleared under K060372 for lamellar corneal resections and incisions.

BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS:

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

Page 2 of 2

(02/01/2007) K063682 S OF 6

1-11

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IntraLase Corp. c/o Judy F. Gordon, DVM ClinReg Consulting Services, Inc. 733 Bolsana Dr. Laguna Beach, CA 92651

9 2007 FEB

Re: K063682

Trade/Device Name: IntraLase® Fusion™ Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Codes: GEX, HNO Dated: December 8, 2006 Received: December 11, 2006

Dear Dr. Gordon:

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.

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.

{3}------------------------------------------------

Page 2 - Judy F. Gordon, DVM

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egelman Si MD

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

{4}------------------------------------------------

IntraLase Corp.

CDRH INDICATIONS FOR USE

510(k) Number (if known): K063682

. ..

IntraLase Fusion™ Laser Device Name(s):

Indications for Use:

The IntraLase Fusion™ Laser is an ophthalmic surgical laser indicated for use in the creation of corneal flaps in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

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)

oncurrence of CDRH, Office of Device Evaluation (ODE)

Muska R. Burke Nicholas
(Division Sign Off)

sion of Ophthalmic Ear Nose and Throat Devi

510(k) Number

Page 1 of __ 1__

3 OF 5 (02/01/2007) K063682

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.