The LenSx 550 Laser System is indicated for use in the creation of a partial thickness cut/incision for lamellar keratoplasty and in the creation of a full-thickness cut/incision for penetrating keratoplasty.

Device Description

The LenSx 550 Laser is an ophthalmic surgical laser indicated for use in the creation of a penetrating cut/incision for penetrating and lamellar keratoplasty. Consistent with commercially available femtosecond lasers (Product Code GEX, 878.4810 and OOE, 886.4390) the LenSx 550 Laser creates incisions using focused femtosecond laser pulses. Individual photodisruption locations are controlled by repositioning the laser focus in the cornea. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incision. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through an off-the-shelf, disposable contact lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

AI/ML Overview

The LenSx 550 Laser System is an ophthalmic surgical laser. The provided text outlines a 510(k) summary for this device, focusing on its substantial equivalence to predicate devices for creating penetrating and lamellar keratoplasty incisions. However, it does not describe specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for a detailed performance evaluation of a device like an AI algorithm.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. It lists general performance areas evaluated but not specific quantitative criteria or results.

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

This information is not provided as a test set in the context of an AI algorithm evaluation. The document refers to "nonclinical tests and results" but provides no details on 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

This information is not provided. As no "test set" in the context of AI evaluation is described, there's no mention of ground truth experts.

4. Adjudication method for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is an ophthalmic surgical laser, not an AI-assisted diagnostic or interpretative tool.

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

This information is not applicable/provided. The device is a surgical laser, not a standalone algorithm.

7. The type of ground truth used

This information is not provided.

8. The sample size for the training set

This information is not provided. As the device is not an AI algorithm, there is no "training set."

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

This information is not provided.

Summary of what is stated regarding performance and evaluation from the document:

The document states that nonclinical tests were performed to support the safety and substantial equivalence of the LenSx 550 femtosecond laser system to predicate devices. These tests demonstrated the following:

Accuracy and reproducibility of the depth and geometry of penetrating cuts/incisions: This is a key performance aspect for a surgical laser, implying that the device consistently creates cuts with the intended dimensions.
Ability to create penetrating corneal incisions in opacified corneas: This highlights the device's efficacy across different corneal conditions.
Limited collateral tissue effects and retained endothelial cell viability adjacent to penetrating laser corneal incisions as compared to manual trephination: This points back to safety and potentially improved outcomes compared to the traditional manual method.

In conclusion, while the document confirms that performance data was generated to support the 510(k) clearance, it does not detail specific acceptance criteria, quantitative performance metrics, or the methodologies (sample sizes, expert involvement, ground truth establishment) typically associated with evaluating AI-driven diagnostic or interpretative devices. The evaluation here is for a surgical instrument, focusing on its physical capabilities and safety profile in comparison to existing technologies.

Summary

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K092647

DEC 1 1 2009

2.0 510(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 2.1 DATE SUMMARY PREPARED

a. Applicant: LenSx Lasers, Inc. 33 Journey, Suite 175 Aliso Viejo, CA 92656 Tel: (949) 360-6010 Fax: (949) 360-6028
b. Contact Person: Judy Gordon, D.V.M. ClinReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651 judy@clinregconsulting.com Tel: (949) 715-0609 Fax: (949) 715-0610

2.2 NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME

a.	Trade/Proprietary Name:	LenSx 550 Laser System
b.	Common/Usual Name:	: LenSx 550 Laser System
C.	Classification Name:	Laser Instrument, Surgical, Powered
d.	Classification Code(s):	21 CFR 886.4390 ; 79 OOO

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2.3 PREDICATE DEVICES

510(K) #	TRADE NAME	MANUFACTURER
K082947	LenSx 550 Laser System	LenSx Lasers, Inc.
K041893	IntraLase FS Laser	Abbott Medical Optics
K981063	Automated Corneal Trephine	Laser Center DevelopmentCorporation
K013151	ASMOTOM AutomatedTrephine System	BKG Ophthalmics USA, Inc
K864520	Barron Rotary Blade TrephineUsing Hessburg-Barron	Precision Instruments, Inc.
K861825 -	Corneal Transplant TrephineDisposable Blade	Storz Instrument Co.

2.4 DEVICE DESCRIPTION

2.5 STATEMENT OF INTENDED USE

The LenSx 550 laser has the same indication for use as the Automated Corneal Trephine (K981063), the ASMOTOM Automated Trephine System (K013151) and the IntraLase FS Laser (K041893).

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TECHNOLOGICAL CHARACTERISTICS COMPARISON 2.6

The LenSx 550 laser has the same fundamental scientific technology and operating principle as the LenSx 550 Laser (K082947) and the IntraLase FS Laser (K041893) and is therefore substantially equivalent to these legally marketed predicate devices.

2.7 BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS

The performance data supporting safety and substantial equivalence of the LenSx 550 femtosecond laser system to the predicate devices demonstrate the following:

The accuracy and reproducibility of the depth and geometry of penetrating . cuts/incisions
. The ability to create penetrating corneal incisions in opacified corneas
. The limited collateral tissue effects and retained endothelial cell viability adjacent to penetrating laser corneal incisions as compared to manual trephination.

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

ClinReg Consulting Services, Inc. c/o Judy F. Gordon, D.V.M. Regulatory Consultant to LenSx Lasers, Inc. 733 Bolsana Dr. Laguna Beach, CA 92651

DEC 1 1 2009

Re: K092647

Trade/Device Name: LenSx® 550 Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser . Regulatory Class: II Product Code: OOE Dated: November 30, 2009 Received: December 1, 2009

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 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 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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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/ucm11.5809.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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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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510(k) Number (if known):__K 09 2 64 7

Device Name(s): LenSx 550 Laser System

Indications for Use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE),

Page 1 of 1 (Division Sign-Off)

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

510(k) Number K092647

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.