The LensAR Laser System is an ophthalmic surgical laser intended for use in anterior capsulotomy in cataract surgery. The System employs a mode-locked Nd: Y VO4 laser which generates a high frequency series of ultrashort, low energy pulses at a wavelength of 1064 nm. The system is designed to cut the lens capsular tissue, with minimal collateral damage, by the mechanisms of plasma mediated ablation and photodisruption of targeted tissue at the beam focus. The precision capsulotomy is generated by computer-controlled scanning of the position of the laser beam focus in three dimensions at the target location of the anterior capsulotomy. The laser energy is delivered to the eye through a disposable, patient interface device consisting of an Index Matched Eye Docking device (IMED) designed to match the refractive index of the cornea to optimize beam targeting accuracy. The IMED device is docked to the eye via an accessory component comparable to those used with other ophthalmic lasers used as keratomes.

AI/ML Overview

This document describes the premarket notification 510(k) for the LensAR Laser System for Anterior Capsulotomy.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Creation of uniform, accurate, and predictable anterior capsulotomies (size and depth).	The data demonstrated the LensAR produces anterior capsulotomies that are uniform, accurate, and predictable in size (based on testing in porcine eyes and plastic substrates). Clinical analysis included pointing accuracy and performance characteristics for achieving an effective anterior capsulotomy cut.
Safety with respect to corneal endothelium (acoustic and thermal profile).	Evaluation on ex vivo porcine eyes confirmed the safety with respect to corneal endothelium.
Successful performance of anterior capsulotomy, with successful intraocular lens placement.	Anterior capsulotomy was successfully performed in eyes using the LensAR Laser, with intraocular lenses successfully placed. Postoperatively, the course of follow-up through 3 months was unremarkable. The intraocular lens was centered in all study eyes. All capsulotomies were judged well-centered by visual inspection.
Ease of removal of capsules comparable to or better than Continuous Curvilinear Capsulorhexis (CCC).	The ease of removal scores were 5 or better (on a scale of 1 to 10, where 1 = CCC/manual removal, 10 = easiest), with the most common score being 10.
Anterior capsules from laser-treated eyes should be equivalent or better with respect to dimension and conformance to circularity than those done manually.	The removed anterior capsules from the laser-treated eyes were demonstrated to be equivalent or better with respect to dimension and conformance to circularity than those done manually.
No significant difference in clinical outcomes from the sequelae of cataract surgery between treatment and conventional cataract surgery (CCC) populations.	No significant difference in clinical outcomes from the sequelae of cataract surgery was demonstrated between the Treatment and Treated Control populations.

Sample sizes used for the test set and data provenance
- Test Set (Clinical): The study was a "prospective, single-center, multiple surgeon clinical trial." No specific sample size is provided for the number of eyes or patients in the LensAR Laser arm. The report mentions a "contralateral control population," suggesting at least some patients had one eye treated with LensAR and the other with CCC, but also states "not all fellow eyes underwent cataract surgery in the context of the clinical study."
- Data Provenance: The clinical trial was a prospective, single-center study. The country of origin is not explicitly stated, but the submission is to the FDA in the USA.
- Pre-Clinical Testing: Porcine eyes and plastic substrates were used for accuracy, reproducibility, acoustic, and thermal profile testing.
Number of experts used to establish the ground truth for the test set and qualifications of those experts
- The document does not explicitly state the number of experts or their qualifications for establishing ground truth.
- However, it does mention that "All capsulotomies were judged to be well centered by the surgeon using visual inspection in the operating microscope," indicating that the treating surgeons provided some form of assessment.
Adjudication method for the test set
- The document does not describe a formal adjudication method (like 2+1 or 3+1). The assessment of capsulotomy centering was done by the operating surgeon via visual inspection.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical laser system, not an AI-assisted diagnostic or imaging device used by human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, the device's performance was evaluated in a standalone manner. The LensAR Laser System performs the anterior capsulotomy itself, and its performance characteristics (accuracy, reproducibility, safety, quality of cut) were assessed pre-clinically and clinically. The laser is a computer-controlled system for creating the cut.
The type of ground truth used
- Clinical Ground Truth: Surgical success (successful capsulotomy and IOL placement, unremarkable postoperative course, centered IOLs), surgeon's visual inspection for capsulotomy centering, and subjective surgeon judgment for ease of capsule removal. The removed anterior capsules were also physically analyzed for dimension and circularity.
- Pre-Clinical Ground Truth: Measurements of capsulotomy size and depth in porcine eyes and plastic substrates, and evaluation of acoustic and thermal profiles in ex vivo porcine eyes.
The sample size for the training set
- No information is provided regarding a separate "training set" for the device itself. The device is a surgical instrument with computer control, not a machine learning algorithm that requires a distinct training dataset in the same sense as an AI diagnostic tool. The development process likely involved internal testing and refinement (bench testing and ex vivo studies) that could be considered analogous to iterative development, but it's not described as a formal "training set."
How the ground truth for the training set was established
- As there's no explicitly defined "training set" in the context of an AI algorithm, details on how ground truth was established for it are not applicable here. The device's design and parameters were likely optimized through engineering and bench testing, for which the "ground truth" would be objective measurements of physical parameters and cut quality against design specifications.

Summary

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K090633

Premarket Notification 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

Applicant:	LensAR, Inc.250 South Park Avenue, Suite 310Winter Park, FL 32789	MAY 1 3 2010
Contact Person:	Keith EdwardsDirector, Clinical/Regulatory AffairsTel: (888) 892-5171Fax: (407) 386-7228

Date Summary Prepared: November 16, 2009

NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME

Trade/Proprietary Name:	TBD
Common/Usual Name:	LensAR Laser System for Anterior Capsulotomy
Device Classification:	Nd:YAG Laser for Posterior Capsulotomy and Peripheral Iridotomy, Class II, 21 CFR 886.4392 Radiofrequency Electrosurgical Cautery Apparatus, Class II, 21 CFR 886.4100 Ophthalmic Femtosecond Laser, Class II, 21 CFR 886.4390
Product Code(s):	NCR, LXS, OOE

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PREDICATE DEVICES:

510(K) Number	TRADE NAME	MANUFACTURER
K892058	ISL QC 2000	Intelligent Surgical Lasers
K001498	The Fugo Blade	Medisurg Research andManagement Corp.
K082947	LenSx	LenSx Lasers, Inc.33 Journey, Suite 175Aliso Viejo, CA 92656
And by LenSx reference the following devices:
K033354	FEMTEC LaserMicrokeratome	20/10 Perfect Vision OptischeGerät GMBH
K993153, K001211,K002890, K013941,K031960, K041893,K060372, K063682,andK073404	IntraLase FS Lasers	IntraLase Corp.

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

The LensAR Laser System is intended for use in anterior capsulotomy during cataract surgery.

TECHNOLOGICAL CHARACTERISTICS COMPARISON

As with the other ultrashort pulse lasers, the LensAR uses a mode-locked lasing technology rather than the Q-switched technology used for nanosecond or longer pulse lasers. The ultrashort pulses ionize target tissue molecules, creating free electrons through

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a multi-photon absorption process rather than thermionic emission, the prevalent mechanism for somewhat longer pulse lasers. The electron avalanche and optical breakdown initiated by the free electron generation causes plasma formation and plasma mediated ablation as one of the cutting mechanisms.

The LensAR laser, like the LenSx, ISL QC 2000, Intralase (and others such as the FemTec laser), has laser beam and optical delivery system characteristics designed to generate a beam fluence at the beam waist that is enough above the laser induced optical breakdown (LIOB) threshold that the mechanical effects of shock waves and cavitation bubbles which are caused by the rapid plasma expansion constitute a substantial portion of the overall cutting process. The cutting of tissue by lasers via the aforementioned mechanical forces is termed photodisruption. The combination of substantial contributions to the cutting phenomenon from both plasma mediated ablation and photodisruption, as with the LensAR and other ultrashort pulse ophthalmic lasers cited above contrasts with the primarily laser mediated ablation mechanism utilized by ultrashort pulse lasers operating just above the LIOB or primarily photodisruption utilized by longer pulse Q-switched lasers.

Finally, like the other ultrashort pulse predicate devices, the LensAR laser uses a series of high frequency pulses which are scanned in three dimensions through the target tissue, by a computer-controlled optical scanning system, to create a contiguous cut. The ability to create a contiguous cut depends on matching the pulse-to-pulse spacings in three dimensions, to the three dimensional spatial extent of the plasma mediated ablation and photodisruption for the particular laser pulse width, pulse energy and optical delivery system characteristics.

The laser photodisruption plasma and the subsequent gas bubble are much smaller and more precise than an RF excited filament can achieve. If the focal spot is moved through the tissue in the appropriate pattern, macroscopic cuts can be performed that mimic those achieved with the Fugo Blade in the device-assisted anterior capsulotomy procedure in quality, but are much more controllable and repeatable in their key parameters since the cut is completely computer-controlled.

The LensAR Laser is, therefore, substantially equivalent to these legally marketed predicate devices.

BRIEF SUMMARY OF NON-CLINICAL TESTS AND RESULTS:

LensAR has developed the LensAR Laser for use in anterior capsulotomy, employing the precision and control of ultrashort pulse lasers for this procedure. Pre-clinical and clinical testing has included bench testing and a prospective, single-center, multiple surgeon clinical trial.

Summary of Pre-Clinical Testing

Testing and analyses performed included accuracy and reproducibility of capsulotomy size and depth in porcine eyes and plastic substrates. The data demonstrated the LensAR produces anterior capsulotomies that are uniform, accurate and predictable in size.

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Additional safety testing was provided that addressed the acoustic and thermal profile of the device. Evaluation on ex vivo porcine eyes confirmed the safety with respect to corneal endothelium.

Summary of Clinical Testing

A clinical trial of the LensAR Laser was conducted to evaluate the performance of this laser system in the creation of anterior capsulotomy during cataract/10L surgery, followed by conventional cataract removal. A contralateral control population which underwent continuous curvilinear capsulorhexis (CCC) and conventional cataract removal served as the comparative control, although not all fellow eyes underwent cataract surgery in the context of the clinical study. Clinical analysis included the pointing accuracy of the device, as well as the performance characteristics required to achieve an effective anterior capsulotomy cut.

Anterior capsulotomy was successfully performed in eyes using the LensAR Laser, with intraocular lenses successfully placed. Postoperatively, the course of follow-up through 3 months in the study population was unremarkable. The intraccular lens was centered in all study eyes. All capsulotomies were judged to be well centered by the surgeon using visual inspection in the operating microscope.

The ease of removal of the capsules was judged (on a scale of 1 to 10), with 1 being assigned as the score for Continuous Curvilinear Capsulorhexis (i.e., manual removal) and 10 being easiest to remove. All scores were 5 or better with the most common score being 10.

The removed anterior capsules from the laser treated eyes were demonstrated to be equivalent or better with respect to dimension and conformance to circularity than those done manually.

No significant difference in clinical outcomes from the sequelae of cataract surgery was demonstrated between the Treatment and Treated Control populations.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.

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

LensAR, Inc. c/o Ms. Shirley McGarvey Consultant to LensAR 250 South Park Avenue Winter Park, FL 32789

MAY 1 8 2010

Re: K090633

Trade Name: LensAR Laser System for Anterior Capsulotomy Regulation Number: 21 CFR 886.4392 Regulation Name: Nd: YAG laser for posterior capsulotomy and peripheral iridotomy Regulatory Class: Class II Product Code: OOE Dated: April 22, 2010 Received: April 23, 2010

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, 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 Eederal 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

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Page 2 - Ms. Shirley McGarvey

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.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation cntitled, "Misbranding by reforence 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 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

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Indications for Use Statement
510(k) Number (if known):	K090633
Device Name:	LensAR Laser System for Anterior Capsulotomy
Indications for Use:	The LensAR Laser System is indicated for anterior capsulotomy in cataract surgery.

Indications for Use Ct.

Prescription Use: X And/Or (Part 21 CFR 801 Subpart D)

Over-the-Counter Use: (Part 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)

Aem.

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

510(k) Number K090633

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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.