The LenSx 550 Laser is an ophthalmic surgical laser intended for use in patients requiring an anterior capsulotomy. The LenSx 550 Laser focuses a beam of low energy pulses of infrared light into the anterior lens. Consistent with commercially available femtosecond lasers used for lamellar resection of the cornea (GEX, 878.4810), the cutting effect is produced by scanning individual pulses 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. Finally, the laser pulses are delivered through an off-the-shelf disposable contact lens that contacts the cornea and fixes the eye with respect to the delivery system.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details based on the provided text, where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pre-Clinical:
Uniform capsulotomy	Produced uniform capsulotomies
Accurate capsulotomy size	Produced accurate capsulotomies in size
Predictable capsulotomy size	Produced predictable capsulotomies in size
Smooth capsular edge	Capsular edge was at least as smooth as with manual capsulotomy
Clinical:
Successful anterior capsulotomy (complete, no radial tears, IOL in capsular bag)	Anterior capsulotomy was successfully performed in all eyes (complete in all, no radial tears observed intraoperatively or postoperatively, IOL placed in capsular bag)
Unremarkable postoperative course & centered IOL	Postoperative course was unremarkable, IOL was centered in all study eyes
No posterior capsule tears	No posterior capsule tears were observed
Well-centered capsulotomies (visual inspection by surgeon)	All capsulotomies were judged to be well centered by the surgeon using visual inspection

Note: The document explicitly states "The data demonstrated the LenSx 550 produces anterior capsulotomies that are uniform, accurate and predictable in size over a wide range of depths. The capsular edge created by the LenSx 550 is also at least as smooth as that created during manual anterior capsulotomy." and "Anterior capsulotomy was successfully performed in all eyes using the LenSx 550 Laser. i.e., the capsulotomy was complete in all eyes, with no radial tears observed intraoperatively or postoperatively, and with an intraocular lens placed in the capsular bag. Postoperatively, the course of follow-up in the study population was unremarkable, The intraocular lens was centered in all study cyes, and no posterior capsule tears were observed. All capsulotomies were judged to be well centered by the surgeon using visual inspection in the operating microscope." These statements serve as the direct evidence that the reported device performance met the implied acceptance criteria.

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

Test Set Sample Size (Clinical): The document states "Anterior capsulotomy was successfully performed in all eyes" and "The intraocular lens was centered in all study cyes". However, a specific number of eyes/patients for the clinical trial is not explicitly mentioned in the provided text.
Test Set Sample Size (Pre-clinical): Not specified beyond "porcine eyes and plastic substrates".
Data Provenance: The document explicitly states a "prospective, single-center clinical trial." The country of origin is not explicitly mentioned, but it is implied to be within the scope of FDA approval (likely US-based or an internationally recognized clinical trial site).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: For the clinical study, the document states "All capsulotomies were judged to be well centered by the surgeon using visual inspection in the operating microscope." This implies at least one surgeon served as the expert for this specific judgment. The exact number of surgeons involved in the study is not specified, nor is their specific level of experience/qualification beyond being a "surgeon."
Qualifications of Experts: "Surgeon." More detailed qualifications (e.g., years of experience, subspecialty) are not provided.

4. Adjudication method for the test set

For the judgment of capsulotomy centering, it was done "by the surgeon using visual inspection." This implies a single-reader judgment for this specific criterion, not a multi-reader adjudication method (like 2+1 or 3+1). For other criteria like "no radial tears" or "unremarkable postoperative course," it's not explicitly stated how these were adjudicated beyond general clinical observation by the study team.

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

No, an MRMC comparative effectiveness study was not done. The document describes a study evaluating the performance of the LenSx 550 Laser in creating anterior capsulotomies, not a comparison of human readers with and without AI assistance. The device itself is a laser system, not an AI diagnostic tool for human interpretation.

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

Yes, a standalone performance was essentially done. The LenSx 550 laser system operates as a surgical tool. Its "performance" refers to how accurately and effectively it performs the capsulotomy procedure itself, independent of immediate human interpretation of an image or data generated by the device. The "algorithm" here is the laser's internal control system determining the cut. The clinical trial directly evaluated the outcome of the laser's action.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical study was primarily clinical outcome data and surgeon's visual assessment. This included:
- Observation of capsulotomy completeness
- Absence of radial tears (intraoperative and postoperative)
- Placement of IOL in the capsular bag
- Unremarkable postoperative course
- Centered IOL (clinical observation)
- Absence of posterior capsule tears
- Surgeon's visual judgment of capsulotomy centering
For pre-clinical testing, it involved measurements from porcine eyes and plastic substrates, along with scanning electron microscopy.

8. The sample size for the training set

Not applicable / Not specified. The LenSx 550 Laser is a surgical device, not a machine learning algorithm that requires a separate "training set" in the conventional sense for its function. Its design and operational parameters would be developed through engineering and iterative testing, not through supervised learning on a "training set" of patient data.

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

Not applicable. As above, the concept of a "training set" and associated "ground truth" for a medical device like a surgical laser system doesn't align with the typical machine learning paradigm. The device's operational specifications are derived from engineering principles and tested against established performance requirements.

Summary

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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(a).

SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED

a.	Applicant:	LenSx Lasers, Inc.33 Journey, Suite 175Aliso Viejo, CA 92656Tel: (949) 360-6010Fax: (949) 612-1843
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

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.	Device Classification:	Ophthalmic Femtosecond Laser, Class II,21 CFR 886.4390
d.	Product Code:	OOE

ರ. Product Code:

K082947- SUMMARY OF SAFETY AND EFFECTIVENESS

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PREDICATE DEVICES

510(k) #	TRADE NAME	MANUFACTURER
K001498	The Fugo Blade	Medisurg Research andManagement Corp.
K040005	Profile 3000 laser System andDelivery Devices andAccessories	Sciton, Inc.
K052806	Burane Laser System	WaveLight Laser Technologie,AG
K021548	Fotona DualisNd:YAG/Er:YAG Laser System	Fontona D.D.
K033354	FEMTEC Laser Microkeratome	20/10 Perfect Vision OptischeGerate GMBH
K993153, K001211,K002890, K013941,K031960, K041893,K060372, K063682, andK073404	IntraLase FS Lasers	IntraLase Corp.

DEVICE DESCRIPTION

STATEMENT OF INTENDED USE

The LenSx 550 Laser System is indicated for anterior capsulotomy during cataract surgery.

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TECHNOLOGICAL CHARACTERISTICS COMPARISON

The LenSx 550 laser shares a similar intended use, and indication for use as the Fugo Blade by Medisurg Research and Management Corp., the Profile 3000 Laser System (K040005), the Burane Laser System (K052806) and the Fontona Dualis Nd:YAG/Er:YAG Laser System (K021548). The LenSx 550 mode of operation and the technology utilized to create the cutting action are similar to the 20/10 Perfect Vision FemTec Laser Microkeratome, and the IntraLase FS Lasers and is therefore substantially equivalent to these legally marketed predicate devices.

BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS

LenSx has developed the LenSx 550 for use in anterior capsulotomy, employing the precision and control of femtosecond lasers for this procedure. Pre-clinical and clinical testing has included bench testing and a prospective, single-center 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, as well as scanning electron microscopy. The data demonstrated the LenSx 550 produces anterior capsulotomies that are uniform, accurate and predictable in size over a wide range of depths. The capsular edge created by the LenSx 550 is also at least as smooth as that created during manual anterior capsulotomy.

Summary of Clinical Testing

A clinical trial of the LenSx 550 Laser was conducted to evaluate the performance of this laser system in the creation of anterior capsulotomy during cataract/IOL surgery. Anterior capsulotomy was successfully performed in all eyes using the LenSx 550 Laser. i.e., the capsulotomy was complete in all eyes, with no radial tears observed intraoperatively or postoperatively, and with an intraocular lens placed in the capsular bag. Postoperatively, the course of follow-up in the study population was unremarkable, The intraocular lens was centered in all study cyes, and no posterior capsule tears were observed. All capsulotomies were judged to be well centered by the surgeon using visual inspection in the operating microscope.

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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 stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

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

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

AUG 1 4 2009

Re: K082947

Trade/Device Name: LenSx 550 Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: II Product Code: OOE Dated: July 8, 2009 Received: July 9, 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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Page 2 - Judy Gordon, D.V.M.

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/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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Kesia Alexander for

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): K082947

LenSx 550 Laser System Device Name(s):

Indications for Use:

The LenSx 550 Laser System is indicated for anterior capsulotómy during cataract surgery.

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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Bruce Drum

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

510(k) Number K082947

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.