The LenSx Laser is indicated for use:
· In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate), 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 corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Device Description

The LenSx Laser System is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create incisions and to separate tissue within the lens capsule, crystalline lens, and the cornea. A femtosecond light pulses 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. A computer-controlled scanning system directs the focused laser beam throughout a three-dimensional pattern to produce an incision. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incision or tissue separation.
The laser pulses are delivered through a Patient Interface accessory that is placed on the surface of the cornea and fixes the position of the eye with respect to the delivery system. Two models of the Patient Interface accessory are offered for use with the LenSx Laser System: the LenSx Laser Patient Interface and the LenSx SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system. The LenSx SoftFit Patient Interface model is offered with three different sizes of soft contact lenses that are positioned against the internal surface of the patient Interface glass. For cataract procedures, the LenSx SoftFit Patient Interface is used. For corneal flap procedures, the LenSx Laser Patient Interface is used.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Metric)	Reported Device Performance
Accuracy and reproducibility of the depths and geometry of previously cleared cataract treatment patterns using the LenSx Laser System.	Performance testing on the new SoftFit Insert sizes showed that the device is as safe and as effective as the predicate device. The new sizes maintain the accuracy and reproducibility of the depths and geometry of each of the previously cleared cataract treatment patterns for the LenSx Laser.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size used for the performance testing of the new SoftFit Insert sizes. It generally states "Performance testing on the new sizes."

The data provenance is not explicitly stated (e.g., country of origin). The testing described appears to be internal device validation rather than a clinical study with patient data provenance in the context of country of origin. The study is prospective in nature, as it involves testing new versions of a device component.

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

This information is not provided in the document. The performance testing described focuses on objective measurements of device output (accuracy and reproducibility of laser patterns) rather than subjective human assessment requiring expert ground truth in the traditional sense of clinical imaging interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the testing described focuses on objective device performance metrics and does not involve human interpretation or subjective assessment that would require an adjudication method.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed or that AI is involved. The changes relate to physical device components (contact lens inserts) and their impact on laser performance during surgery, not an AI-assisted diagnostic or interpretative system.

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

This is not applicable. The device is an ophthalmic surgical laser system, and the changes relate to patient interface accessories. There is no mention of algorithms or AI being evaluated in a standalone capacity within this document.

7. The Type of Ground Truth Used

The ground truth used for this performance testing is based on the objective measurements of the physical outcomes of the laser treatment patterns created by the device, such as the depths and geometry of corneal cuts and capsulotomies. This would likely involve metrology and precision instruments to characterize the laser's output when the new inserts are used, compared to established specifications for the predicate device.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device modification. The device is a physical laser system, not a machine learning or AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set for an AI/ML model for this device.

Summary

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

February 3, 2017

Alcon Laboratories, Inc. Mr. James Arganda Director Global Regulatory Affairs 20511 Lake Forest Dr. Lake Forest, CA 92630

Re: K163551

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: December 13, 2016 Received: December 19, 2016

Dear Mr. Arganda:

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 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 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"

(21 CFR 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,

Denise L. Hampton -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) K163551

Device Name LenSx Laser System

Indications for Use (Describe)

The LenSx Laser is indicated for use:

· In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate), 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 corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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.

Submitter 1.

Applicant:

Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099

Contact Person:

James Arganda Alcon Research, Ltd. 20511 Lake Forest Dr. Lake Forest, CA 92630 james.arganda@alcon.com Tel: (949) 505-7038 Fax: (949) 505-6237

Date Prepared:

February 2, 2017

2. Device

Trade/Proprietary Name:	LenSx Laser System
Common/Usual Name:	Femtosecond laser system
Classification Name:	Laser Instrument, Surgical, Powered
Regulatory Class:	II
Classification Code(s):	21 CFR 886.4390; OOE, HQC, HNC

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3. Predicate Device

LenSx Laser System, K161288

Device Description 4.

The laser pulses are delivered through a Patient Interface accessory that is placed on the surface of the cornea and fixes the position of the eye with respect to the delivery system. Two models of the Patient Interface accessory are offered for use with the LenSx Laser System: the LenSx Laser Patient Interface and the LenSx SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system. The LenSx SoftFit Patient Interface model is offered with three different sizes of soft contact lenses that are positioned against the internal surface of the patient Interface glass. For cataract procedures, the LenSx SoftFit Patient Interface is used. For corneal flap procedures, the LenSx Laser Patient Interface is used.

5. Indications for Use

The following indications for use for the LenSx Laser System are unchanged from the previously cleared device (K161288):

. In the creation of corneal cuts/incisions (single-plane, multi-plane and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.

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In the creation of a corneal flap in patients undergoing LASIK surgery or other . treatment requiring initial lamellar resection of the cornea.

Technological Characteristics Comparison 6.

The subject of this 510(k) Premarket Notification is the offering of two additional sizes of the soft contact lens insert used with the SoftFit Patient Interface accessory that is currently sold for use with the LenSx Laser System. These additional sizes are being offered to better accommodate variations in corneal curvature and enhance patient comfort during docking of the laser objective prior to treatment. The original universal size (nominal) remains unchanged with a central base curve of 7.6 mm. The additional sizes will include:

a contact lens insert with a central base curve of 7.2 mm for steeper corneas with an . average K-reading greater than >46 D; and
a contact lens insert with a central base curve of 8.1 mm for flatter corneas with an . average K-reading of <41 D.

All three SoftFit inserts will be used with the existing LenSx Laser SoftFit Patient Interface Cone.

There are no changes to the LenSx Laser System hardware or software. There are no changes to intended use, the indications for use, or product claims of the LenSx Laser System as a result of the proposed change.

All modifications were tested to show substantial equivalence and were as safe and effective as the predicate device. The following summarizes the substantial equivalence between the modified device and the predicate device.

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TECHNOLOGICAL COMPARISON OF THE ORIGINAL SOFTFIT INSERT AND THE PROPOSED SOFTFIT INSERTS

	LenSx® LASER SYSTEMK161288PREDICATE	LenSx® LASER SYSTEMPROPOSED
Trade Name	LenSx® Laser System,	LenSx® Laser System
Indication forUse	The LenSx Laser System is indicated for use:• In the creation of corneal cuts/incisions(single-plane, multi-plane, and arcuate),anterior capsulotomy and laserphacofragmentation during cataract surgery.Each of these procedures may be performedeither individually or consecutively during thesame surgery.• In the creation of a corneal flap in patientsundergoing LASIK surgery or other treatmentrequiring initial lamellar resection of thecornea	Same
Contact LensMaterial	efrofilcon A, 74% water	Same
Sizes Available	Nominal	Nominal<41 D>46 D
Method ofSterilization	Steam Autoclave	Same
Use	Single Use	Same

Brief Summary of Performance Test Results 7.

The performance data supporting substantial equivalence of the SoftFit Patient Interface accessory includes evaluation of the accuracy and reproducibility of the depths and geometry of each of the previously cleared cataract treatment patterns for the LenSx Laser when the SoftFit Patient Interface is used with the new insert sizes.

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8. Conclusions

The subject of this 510(k) Premarket Notification is the addition of two new SoftFit Insert sizes and the labeling and risk analysis changes to support these additional models. Performance testing on the new sizes show that the device is as safe and as effective as the predicate device.

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.