The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Device Description

The predicate LENSAR Laser System is an ophthalmic surgical laser that has been cleared by the Agency for use in anterior capsulotomy and laser phaco fragmentation in cataract surgery performed individually or consecutively during the same surgery under K120214 (LENSAR Laser System - fs 3D). In K122829, the laser expands the Indication for Use to single-plane and multi-plane clear corneal cuts/incisions. This expansion of the Indication for Use is for partial as well as full thickness single-plane and multi-plane arc cuts/incisions in the cornea.

The current LLS-fs 3D uses the same laser and the same beam guidance system to deliver laser pulses to the eye as the predicate LENSAR device cleared via 510(k) K120214 and K 122829. Also, the patient interface device (PID), controlled force docking mechanism and moveable optical head to dock the laser to the stationary patient are unchanged from that 510(k) K120214 and K122829.

The LLS-fs 3D biometric system, which measures and constructs a three dimensional model of the optical surfaces within the eye, is unchanged from the predicate device except for software modifications to allow the system to analyze the shape and position of the peripheral cornea. To improve the accuracy of incision placement in the cornea, a new functionality called "Localized Imaging" has been added to the system. Localized Imaging is a process whereby the biometric camera is positioned to observe the corneal incision site and a very small laser mark (at low energy) is made at the center of the stroma. By imaging and measuring the position of the mark relative to the cornea anterior and posterior surfaces, the system mitigates any potential of incorrect laser beam placement due to eve movement. The corneal incision surgery is performed immediately after Localized Imaging and results in accurate incision depth in the cornea (<75 microns error).

The Indication for Use was expanded to include creation of the corneal incisions for entry to the eye in cataract surgery in K122829 and is now further expanded to include partial thickness corneal arc cuts/incisions.

AI/ML Overview

Acceptance Criteria for LENSAR Laser System - fs 3D (LLS-fs 3D)

Based on the provided 510(k) summary, the acceptance criteria for the LLS-fs 3D, specifically regarding the new indication of partial thickness corneal incisions, revolve around demonstrating comparable or superior accuracy and safety compared to conventional manual techniques and the previously cleared predicate devices.

The primary performance metric evaluated for the new indication of partial thickness corneal incisions appears to be accuracy of incision depth. The goal was to show that laser-created partial thickness incisions (PTIs) achieved depths much closer to the target than manually-created PTIs, and that there was no significant difference in accuracy or variance between human and porcine eyes, and no detrimental effect on endothelial cells.

Here's a breakdown of the acceptance criteria and reported device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (as stated in the summary)
Accuracy of Incision Depth for Partial Thickness Corneal Incisions (PTIs): Laser PTIs must demonstrate superior or comparable accuracy to target depth compared to manual methods. (Target depth explicitly mentioned as 600 µm for testing)	"The accuracy of the depth of conventional manual versus laser-generated partial thickness corneal incisions (PTIs) was tested... A comparison of the depth accuracy of manual and laser PTIs demonstrated that the laser PTIs had measured depths much closer to the target 600 um depth than the manually-created PTIs." "The results showed that the mean errors in target accuracy were not different and the variance of the error in incision depth was also about the same [between porcine and human donor globes]." "Overall, the testing showed that PT's created by the LLS-fs 3D were more accurate and precise than those made using a diamond blade with the conventional manual technique."
Safety - Effect on Endothelial Cells: No significant loss of endothelial cell density due to laser PTIs.	"Evaluation of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes showed that the laser method resulted in no loss of endothelial cell density when the residual corneal bed is maintained at >85um."
Safety - Absence of new hazards or acceptable probability/severity for existing hazards: The addition of partial thickness arc cuts/incisions should not introduce new, unacceptable hazards, or exacerbate existing ones to unacceptable levels.	"The addition of partial thickness arc cuts/incisions did not result in additional hazards although the probabilities and severities of some of the hazards identified for the predicate device were changed." (Implies these changes were within acceptable levels based on the overall conclusion of substantial equivalence).
Optical Radiation Hazard: Device must be eye safe under normal operating and fault conditions.	"An analysis of the optical radiation hazard to non-target tissue demonstrated that the current LLS-fs 3D femtosecond laser, biometric system scanning diode light source, and patient eye illumination (light emitting diodes) are eye safe under all normal operating and known fault conditions."
General Hazard Analysis: All potential hazards to patient, surgeon, and operators must have acceptable probability/severity.	"A hazard analysis of all potential hazards to the patient, surgeon and other system operators was performed to consider all changes between the current LLS-fs 3D and predicate LLS-fs 3D device. The hazard analysis demonstrates that all potential hazards have acceptable levels of probability/severity characteristics."

2. Sample Sizes and Data Provenance

Test Set Sample Sizes:
- Porcine ex vivo eyes: "The accuracy of the depth of conventional manual versus laser-generated partial thickness corneal incisions (PTIs) was tested using a porcine ex vivo eye model." (Specific number of eyes not quantified, but tested).
- Human donor globes: "The laser PTIs in porcine eyes were compared to a smaller number of laser PTIs in human donor globes." (Specific number of globes not quantified, but referred to as "smaller number").
- Endothelial cell study: "Evaluation of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes..." (Source of ex vivo eyes not specified, but likely porcine or human donor as implied by other tests. Specific number not quantified).
Data Provenance:
- The studies were "ex vivo," meaning performed on excised tissues, not live subjects.
- The origin (e.g., country) of the porcine or human donor eyes is not specified.
- The studies were likely retrospective in nature, as they utilize ex vivo samples for controlled measurements. They are presented as performance tests supporting a 510(k) submission, typical of pre-market validation.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth for the test set.
It also does not specify the qualifications of any experts involved in defining or adjudicating the ground truth. The ground truth ("measured depths") was established using an "optical coherence tomographer" which implies objective measurement, rather than expert interpretation of images.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. The ground truth for incision depth was established through objective measurement using "an optical coherence tomographer," which typically involves automated or semi-automated measurement, reducing the need for human adjudication of subjective interpretations.

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

No, an MRMC comparative effectiveness study was not done. The studies described were primarily technical performance evaluations (e.g., measuring incision depth accuracy), and safety assessments (e.g., endothelial cell integrity), rather than studies evaluating the impact of AI assistance on human reader performance. This device is not an AI-assisted diagnostic tool that would typically warrant such a study.

6. Standalone Performance Study (Algorithm Only)

Yes, in essence, standalone performance was assessed for the laser's ability to create incisions. The studies evaluated the LLS-fs 3D's performance in creating incisions (accuracy of depth, effect on tissue) in ex vivo eyes, independent of a human surgeon's real-time interaction beyond initiating the procedure. The "Localized Imaging" functionality, which uses the biometric system to image and analyze laser marks to guide subsequent incisions, represents the device's internal "algorithm" controlling the laser's output. The accuracy reported for laser PTIs and the "Localized Imaging" feature ("<75 microns error") is a measure of this standalone algorithmic performance in achieving the intended result.

7. Type of Ground Truth Used

The type of ground truth used was objective measurement data. Specifically, for incision depth, it was "measured depths using an optical coherence tomographer." For endothelial cells, it was the "loss of endothelial cell density," which would also be determined by objective counting and analysis.
This is not an "expert consensus" or "outcomes data" in the clinical sense, but rather direct physical measurement of the device's output on tissue.

8. Sample Size for the Training Set

The document does not specify a training set sample size. This is a medical device (laser system) with software modifications, not a machine learning/AI model in the contemporary sense that would explicitly have a distinct "training set" for model development. The "software modifications" are likely rule-based or algorithmic, rather than data-driven deep learning, meaning there isn't a "training set" in the typical AI/ML context.

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

Since there's no explicitly defined "training set" in the context of an AI/ML model, the concept of establishing ground truth for it is not applicable here. The "ground truth" for the device's design and software adjustments would be the desired physical outcome (e.g., precise incision depth) based on engineering specifications and preclinical data, which would then be validated in the performance tests described. The "Localized Imaging" system is described as using "self-correcting feedback," implying an internal calibration and adjustment loop rather than a trained AI.

Summary

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510(K) SUMMARY

MAR 2 7 2013

This 510(k) summary 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:

LENSAR, Inc. 2800 Discovery Drive, Suite 100 Orlando, FL 32826 Tel: (888) 536-7271 Fax: (407) 386-7228

b. Contact Person:

S.K. McGarvey Regulatory Consultant skmcgg@aol.com Cell: (702) 524-3701 Fax: (407) 386-7228

DATE SUMMARY PREPARED: December 12, 2012

NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME

LENSAR Laser System fs 3D (LLS-fs 3D) a. Trade/Proprietary Name:
b. Common/Usual Name: LENSAR Laser System - fs 3D (LLS-fs 3D)
Ophthalmic Laser, Phacofragmentation System C. Classification Name:
21 CFR 886.4390 OOE; 21 CFR 886.4670 HOC d. Classification Code(s):

PREDICATE DEVICES

510(K) #	TRADE NAME	MANUFACTURER
K122829	LENSAR Laser System - fs 3D	LENSAR, Inc.
K120214	LENSAR Laser System - fs 3D	LENSAR, Inc.
K101626	LenSx 550 Laser System	LenSx Lasers, Inc. (Alcon)

DEVICE DESCRIPTION

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Indication for Use is for partial as well as full thickness single-plane and multi-plane arc cuts/incisions in the cornea.

STATEMENT OF INTENDED USE

TECHNOLOGICAL CHARACTERISTICS COMPARISON

The femtosecond laser system, including pulse energy control and monitoring, used in the current LLS-fs 3D is the same as that used in the predicate device cleared in K120214 and K122829. The primary difference between the current LENSAR Laser System - fs 3D device and the predicate device is the addition of software for the indication of partial ' thickness single-plane and multi-plane arc cuts/incisions in the cornea for cataract surgery.

In the predicate device, the biometric system measured the shape and position of the central cornea for use in the ray tracing necessary to correctly place laser incisions within the crystalline lens. In the current device, corneal measurements are also used to generate custom shot patterns for the corneal incisions. In addition, the current device implements

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Localized Imaging to make the corneal incisions more accurate, the system now images before and after making laser mark(s) and analyzes the images to apply any offsets or tilt in the intended mark position(s) to the subsequent corneal incisions. Both systems are now integrated to provide self-correcting feedback.

510(k) Number	Clearance Date	Device Description
K122829	12/03/2012	LENSAR Laser System - fs 3D (LLS-fs 3D) for creationof single-plane and multi-plane cuts/ incisions in thecornea.
K120214	06/08/2012	LENSAR Laser System - fs 3D (LLS-fs 3D) for anteriorcapsulotomy and laser phacofragmentation
K101626	10/18/2010	LenSx Laser System for anterior capsulotomy,phacofragmentation, and creation of single-plane andmulti-plane arc cuts/incisions in the cornea

The LLS-fs 3D is of comparable type and is substantially equivalent to the following predicate devices:

. The activities used to evaluate the LENSAR Laser System - fs 3D (LLS-fs 3D) and the information and reports provided in this 510(k) submission do not identify any new issues of safety or effectiveness. The optical radiation hazard analysis confirms the continuing ocular safety and the equivalence to the predicate device detailed in 510(k) K120214 and K122829.
. The LLS-fs 3D laser technology and mechanism of laser-tissue interaction are unchanged from that of the femtosecond laser cleared under K120214 and K122829.
The Indication for Use statement for anterior capsulotomy and laser . phacofragmentation for the LLS-fs 3D is the same as that of the predicate 510(k)cleared LENSAR Laser System - fs 3D (K120214) and the indication for use statement for corneal cuts/incisions in the cornea is the same as that for the LENSAR Laser System - fs 3D (K122829). The indication for use statement for corneal are cuts/incisions in the cornea is the same as that for the LenSx Laser (K101626).
. The differences between the modified LLS-fs 3D and the predicate devices are insignificant and do not affect the safety or effectiveness of the device.

BRIEF SUMMARY OF PERFORMANCE TEST RESULTS

The performance data supporting substantial equivalence of the LENSAR Laser System fs 3D to the predicate LENSAR device is summarized as follows:

. An analysis of the optical radiation hazard to non-target tissue demonstrated that the current LLS-fs 3D femtosecond laser, biometric system scanning diode light source, and patient eye illumination (light emitting diodes) are eye safe under all normal operating and known fault conditions.

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A hazard analysis of all potential hazards to the patient, surgeon and other system . operators was performed to consider all changes between the current LLS-fs 3D and predicate LLS-fs 3D device. The hazard analysis demonstrates that all potential hazards have acceptable levels of probability/severity characteristics.
. The accuracy of the depth of conventional manual versus laser-generated partial thickness corneal incisions (PTIs) was tested using a porcine ex vivo eye model. The depths of the incisions were measured using an optical coherence tomographer. A comparison of the depth accuracy of manual and laser PTIs demonstrated that the laser PTIs had measured depths much closer to the target 600 um depth than the manually-created PTIs.
. The laser PTIs in porcine eyes were compared to a smaller number of laser PTIs in human donor globes. The results showed that the mean errors in target accuracy were not different and the variance of the error in incision depth was also about the same.
. Overall, the testing showed that PT's created by the LLS-fs 3D were more accurate and precise than those made using a diamond blade with the conventional manual technique.
· Evaluation of the effect of the laser partial thickness incisions on endothelial cells of ex vivo eyes showed that the laser method resulted in no loss of endothelial cell density when the residual corneal bed is maintained at >85um.
The addition of partial thickness arc cuts/incisions did not result in additional . hazards although the probabilities and severities of some of the hazards identified for the predicate device were changed.

Based on the above supportive documentation, the LENSAR Laser System - fs 3D with modified software to permit partial thickness corneal arc cuts/incisions in cataract surgery is substantially equivalent to the LENSAR Laser for anterior capsulotomy and cataract fragmentation (K120214), and full thickness single-plane and multi-plane clear corneal incisions (K122829) with respect to technological characteristics, and to the LenSx Laser (K101626) for the indication for use in corneal arc cuts/incisions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

March 27, 2013

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

LensAR, Inc. % Ms. S.K. McGarvey Regulatory Consultant 2800 Discovery Drive, Suite 100 Orlando, FL 32826

Re: K123859

Trade/Device Name: Lensar Laser System- fs 3D (LLS-fs 3D) Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Femtosecond Laser Regulatory Class: Class II Product Code: OOE, HOF Dated: February 8, 2013 Received: February 14, 2013

Dear Ms. McGarvey:

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. Iisting 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

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Page 2 - Ms. S.K. McGarvey

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia YAlexander -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): K123859

Device Name: LENSAR Laser System - fs 3D (LLS-fs 3D)

Indications For Use:

The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc cuts/ incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Prescription Use الااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااااا (part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Leonid Livshitz 2013.03.21 16:50:40-04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number: K 123859

Page 1 of

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.