· In the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
· In the creation of a lamellar cut/resection for lamellar keratoplasty, and in the creation of a penetrating cut/incision for penetrating keratoplasty
· 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 LenSx Laser System uses focused femtosecond laser pulses to create incisions and separates tissue in the lens capsule, crystalline lens, and the cornea. Individual photodisruption locations are controlled by repeatedly repositioning the laser focus. 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 incisions or tissue separation.

The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target 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 a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LenSx Laser System:

Acceptance Criteria and Device Performance Study for LenSx Laser System (K120732)

The provided 510(k) summary (K120732) describes modifications to the LenSx Laser System, primarily to add the indication for creating corneal flaps in LASIK surgery. The performance testing focused on demonstrating that the modified device, including the new indication, meets established criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document implicitly defines acceptance criteria by stating that the modified device was evaluated against criteria established for the predicate LenSx Laser and that the output met these. However, the specific quantitative values for these acceptance criteria are not explicitly detailed in the summary. The summary refers to:

Acceptance Criteria Category	Reported Device Performance
Accuracy and Reproducibility of Depths and Geometry (Previously Cleared Treatment Patterns)	The modified LenSx Laser was evaluated and met acceptance criteria established for the predicate LenSx Laser.
Accuracy and Reproducibility of Depths and Geometry (Lamellar Resections)	The modified LenSx Laser was evaluated using the same parameter acceptance criteria as the predicate and met them.
Surface Quality of Lamellar Resections	The modified LenSx Laser was evaluated using the same parameter acceptance criteria as the predicate and met them.
Energy Stability	The modified LenSx Laser was evaluated and met acceptance criteria established for the predicate LenSx Laser.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample size used for the test set. It mentions "Evaluation of the accuracy and reproducibility" but does not give the number of tests performed or the number of samples (e.g., eyes, tissues) used in these evaluations.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin. Given that it's a 510(k) submission for a device manufactured by Alcon LenSx, Inc. (USA) and evaluated for FDA clearance, it's likely the testing was conducted to meet US regulatory standards, possibly in the US or collaborating sites.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not explicitly mention the use of experts to establish a ground truth for the test set in the context of human evaluation. The testing described appears to be objective, physical measurements of the laser's output (depths, geometry, surface quality, energy stability).

4. Adjudication Method for the Test Set

Since the described testing primarily involves physical measurements of laser output rather than subjective interpretation, an adjudication method in the traditional sense (e.g., 2+1, 3+1 for expert review) is not applicable or mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. The device is a surgical laser, and the testing focuses on its physical performance rather than diagnostic accuracy involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The studies described are inherently "standalone" in the sense that they evaluate the physical output of the laser system itself (accuracy, reproducibility, energy stability). The device is a surgical tool, and its efficacy is determined by its ability to perform precise cuts, not by an algorithm's diagnostic output requiring human interpretation.

7. Type of Ground Truth Used

The ground truth used for these performance evaluations would have been objective physical measurements rather than expert consensus, pathology, or outcomes data. For example:

Depth and Geometry: Verified by high-precision metrology tools (e.g., optical coherence tomography, microscopy, or other precise measurement techniques) after laser application to an appropriate test material or ex vivo tissue.
Surface Quality: Evaluated using microscopy or surface profilometry.
Energy Stability: Measured using appropriate power meters and sensors.

8. Sample Size for the Training Set

The document does not specify a training set size. The device is a physical laser system, and its modifications are based on engineering changes and software updates. It's not a machine learning or AI algorithm that would typically require a distinct "training set" in the conventional sense. The "training" in this context would refer to the engineering and design iterations leading to the final device parameters.

9. How Ground Truth for the Training Set Was Established

As there's no explicitly mentioned "training set" in the context of data for an algorithm, the concept of establishing ground truth for it is not applicable as understood for AI/ML devices. The "ground truth" during device development (analogous to a training phase) would have been the engineering specifications and performance targets that the designers aimed to achieve. These targets would have been derived from clinical needs, existing predicate device performance, and scientific understanding of ophthalmic surgery.

Summary

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K120732

SEP 6 2012

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

a.	Applicant: Alcon LenSx, Inc.33 JourneyAliso Viejo, CA 92656Tel: (949) 360-6010Fax: (949) 360-6028
b.	Contact Person: Judy Gordon, D.V.M.

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

Date:

August 8, 2012

NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME

LenSx Laser System Trade/Proprietary Name: a.
- Common/Usual Name: · LenSx Laser System
Laser Instrument, Surgical, Powered Classification Name: c.
- 21 CFR 886.4390; OOE, HQC, HNO Classification Code(s):

PREDICATE DEVICES

510(k) #	TRADE NAME	MANUFACTURER
K101626	LenSx Laser System	LenSx Lasers, Inc.(now Alcon LenSx, Inc.)
K993153	IntraLase Laser	IntraLase Corp.(now Abbot Medical Optics, Inc.)
K041893
K060372
K073404
K101006	WaveLight FS 200Laser System	Alcon Research, Ltd.
K033354	Femtec Laser Microkeratome	20/10 Perfect VisionOptische Gerate GmbH
K100253	Visumax Laser Keratome	Carl Zeiss Meditec

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DEVICE DESCRIPTION

The LenSx Laser System proposed in this 510(k) premarket notification is a modification of the previously cleared LenSx Laser System, manufactured by Alcon LenSx, Inc. (K101626). It is essentially the same laser system with the addition of a new indication for use, namely the creation of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea. This same indication has been cleared for use with multiple predicate femtosecond laser devices since 1999, including the IntraLase Laser (K993153, K041893, K060372, and K073404), the WaveLight FS 200 Laser System (K101006), the Femtec Laser Microkeratome (K033354), and the Zeiss Visumax Laser . Keratome (K100253). Femtosecond lasers now perform the majority of LASIK flaps in the United States and virtually all those performed by the US Armed Forces, with numerous articles documenting their use and advantages. 67,8

STATEMENT OF INTENDED USE

The LenSx Laser System is indicated for use:

· In the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
· In the creation of a lamellar cut/resection for lamellar keratoplasty, and in the creation of a penetrating cut/incision for penetrating keratoplasty
· In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea

6 Panday VA. Reilly CD. Refractive surgery in the United States Air Force. Current Opinion in Ophthalmology 2009, 20:242-246.

7 Kim P, Sutton GL, Rootman DS. Applications of the femtosecond laser in corneal refractive surgery. Current Opinion in Ophthalmology 2011, 22:238-244.

8 Duffey RJ, Leaming D. US Trends in Refractive Surgery: The 2009 ISRS Survey.

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TECHNOLOGICAL CHARACTERISTICS COMPARISON

The LenSx Laser System is essentially the same device as the predicate LenSx Laser System with modifications made to improve usability and manufacturability. These modifications include:

. Software updates to allow for the additional corneal flap pattern
. An increase in the laser repetition rate from 33 kHz to 150 kHz for the flap pattern with maximum possible average power of 1 Watt.
An increase in the laser repetition rate from 33 kHz to 50 kHz for patterns used for the . previously cleared indications in cataract and keratoplasty surgery with maximum possible average power of 1 Watt.
Extension of shelf-life to 24 months for the sterile disposable patient interface. .
Updated user labeling that describes the above changes, as well as changes to the . graphical user interface to improve usability.

BRIEF SUMMARY OF PERFORMANCE TEST RESULTS

The performance data supporting substantial equivalence of the LenSx Laser with the above modifications include:

Evaluation of the accuracy and reproducibility of the depths and geometry of each of . the previously cleared treatment patterns, as well as energy stability using the modified LenSx Laser in comparison to acceptance criteria established for the predicate LenSx Laser
Evaluation of the accuracy and reproducibility of the depths and geometry and surface . quality of lamellar resections using the same parameter acceptance criteria.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

SEP 6 2012

Alcon LenSx, Incorporated % Ms. Judy Gordon, D.V.M. ClinReg Consulting Services, Inc. Regulatory Consultant to Alcon LenSx, Inc. 733 Bolsana Drive Laguna Beach, CA 92651

Re: K120732

Trade/Device Name: LenSx® Laser system Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: OOE, HQC, HNO Dated: August 8, 2012 Received: February 23, 2012

Dear Ms. 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. 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 (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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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

Enclosure

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510(k) Number (if known): K/20732

LenSx Laser System Device Name(s):

Indications for Use:

The LenSx Laser System is indicated for use:

· In the creation of corneal cuts/incisions, anterior capsulotomy and laser
phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
· In the creation of a lamellar cut/resection for lamellar keratoplasty, and in the creation of a penetrating cut/incision for penetrating keratoplasty.
· In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

MZ Burke Nicholas

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

510(k) Number K120732

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)

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Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.