The OptiMedica® Catalys™ Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of 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 Catalys™ Precision Laser System ("Catalys™ System" or "System") is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect phacofragmentation, thus facilitating efficient lens removal. The System also creates 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. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics™ [patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. In addition to the laser classifications per 21 CFR 1040.10 and 1040.11, the Catalys™ Precision Laser System complies with the requirements for Class I lasers per ANSI Z136.1-2007.

AI/ML Overview

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

Acceptance Criteria and Device Performance Study for OptiMedica Catalys™ Precision Laser System

This document describes the bench and animal performance testing conducted to demonstrate the substantial equivalence of the OptiMedica Catalys™ Precision Laser System.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria	Reported Device Performance
Bench Testing (Corneal Incision Accuracy & Precision)	±75um relative to the intended cut dimensions for all corneal incision patterns.	"All measured values met the test protocol acceptance criteria of ±75um relative to the intended cut dimensions." "The spectrum of pattern testing validated the system capability to cut a variety of single plane and multi-plane arc cuts/incisions patterns within specified limits for accuracy and precision."
Animal Testing (Corneal Safety - Histology)	Histological acceptance criteria when compared to standard manual surgical incisions histology. (Note: Specific quantitative criteria are not provided in the summary, but it implies successful comparison to a gold standard).	"Each and all laser created corneal incisions met the histological acceptance criteria when compared to manual surgical incisions histology."
Cadaver Eye Testing (Qualitative Incision Effectiveness)	Qualitative acceptance criteria for effectively cutting a variety of tissue types. (Note: Specific qualitative criteria are not provided, but implies successful tissue cutting).	"Each and all laser created corneal incisions met the qualitative acceptance criteria."

2. Sample Size and Data Provenance

Bench Testing: "Multiple samples for a given test pattern were created in a test substrate." The exact number is not specified.
Animal Testing: The exact number of animals or incisions is not specified.
Cadaver Eye Testing: The exact number of cadaver eyes or incisions is not specified.
Data Provenance: The studies appear to be prospective in nature, conducted specifically for this 510(k) submission to demonstrate the device's performance. The country of origin of the data is not explicitly stated, but it's presumed to be the United States, given the FDA submission context.

3. Number of Experts and Qualifications for Ground Truth

Bench Testing: The ground truth was established by "cross-sectioning and measured using a NIST-traceable reticule, under magnified digital image analysis." This implies technical experts performing measurements, but no specific number or qualifications are provided beyond the NIST traceability.
Animal Testing: The comparison was against "standard manual surgical incisions histology." This implies veterinary pathologists or similar experts would have evaluated the histology, but no details on their number or qualifications are provided.
Cadaver Eye Testing: The ground truth was based on "qualitative acceptance criteria." This would likely involve expert assessment of the incision quality, but no details on the number or qualifications of these experts are provided.

4. Adjudication Method for the Test Set

The reported studies do not describe a specific adjudication method like 2+1 or 3+1. The ground truth appears to be derived directly from measurements (bench testing) or comparative histological/qualitative assessments (animal and cadaver testing), implying single expert or consensual assessment rather than a multi-reader adjudication process with conflict resolution.

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

No information suggesting a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done is present in the provided text. The studies focus on the device's technical performance and safety, not on human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The device, the OptiMedica Catalys Precision Laser System, is an ophthalmic surgical laser system. Its "performance" refers to the accuracy, precision, and safety of the laser actions (capsulotomy, phacofragmentation, corneal incisions) it performs directly, not an AI algorithm that provides diagnostic or assistive outputs for a human. Therefore, a standalone algorithm performance study in the typical sense (e.g., for an imaging AI) is not applicable. The device itself is the "standalone" entity whose performance is being evaluated.

7. Type of Ground Truth Used

Bench Testing: Metrology (NIST-traceable reticule measurements of physical cuts).
Animal Testing: Histopathology (comparison of laser-created incisions to manual incisions).
Cadaver Eye Testing: Qualitative expert assessment of incision effectiveness.

8. Sample Size for the Training Set

The document describes performance testing, not the development or training of an AI algorithm. Therefore, there is no mention of a "training set" in the context of machine learning. The system presumably relies on pre-programmed parameters and control algorithms rather than a learned model from a training set.

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

As stated above, this document does not describe a machine learning model, and thus, no training set or ground truth establishment method for a training set is applicable or provided.

Summary

{0}------------------------------------------------

· AUG 2.8 2012

510(k) Summary

The following 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92:

5.1.1. Applicant

OptiMedica® Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 Phone: 408.850.8600 Fax: 408.583.4380

5.1.2. Contact Person

Alan Marquardt Vice President of Regulatory, Clinical and Quality OptiMedica® Corporation l 310 Moffett Park Drive Sunnyvale, CA 94089 Phone: 408.792.8173 Fax: 408.583.4380 Email: amarquardt(@optimedica.com

5.1.3. Date Prepared

March 23, 2012

5.1.4. Classification

Class II Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Classification Product Code: OOE Classification Product Code Name: Ophthalmic Femtosecond Laser

5.1.5. Trade Name

OptiMedica® Catalys™ Precision Laser System

5.1.6. Predicate Devices

OptiMedica Catalys™ Precision Laser System; K113479 .
LenSx Laser System (Alcon Corporation); K101626 .

5.1.7. Intended Use

{1}------------------------------------------------

5.1.8. Device Description

5.1.9. Substantial Equivalence

The OptiMedica Catalys™ Precision Laser System is substantially equivalent to both predicate devices in terms of indications for use, technological characteristics and performance specifications. The mechanism of laser cutting is the same for all three systems in that the ultra-short laser pulses create a highly localized plasma and subsequent cavitation event that when controlled by a computerized scanning system direct the laser beam through a three-dimensional pattern to produce a precise capsulotomy, fragment the crystalline lens and create arc cuts/incisions in the cornea.

5.1.10. Summary of Bench and Animal Performance Testing

Bench testing of the Catalys™ System was conducted to demonstrate the System's ability to deliver a variety of laser patterns intended for corneal incisions with corresponding accuracy and precision. In this test, the System's entire suite of corneal incision patterns was bracketed to test the full spectrum of physicianselectable pattern variations. Multiple samples for a given test pattern were created in a test substrate that was subsequently cross-sectioned and measured using a NIST-traceable reticule, under magnified digital image analysis. All massurad values met the test protocol acceptance criteria of ±75um relative to the intended cut dimensions. The spectrum of pattern testing validated the system capability to cut a variety of single plane and multi-plane arc cuts/incisions patterns within specified limits for accuracy and precision.

Animal testing was performed to demonstrate corneal safety. In this test, lascr created corneal incisions and standard manual surgical incisions histology was compared. The laser parameters selected for this performance testing represent a worst case type evaluation using the minimum horizontal and vertical spot spacing coupled with maximum pulse energy. Each and all laser created corneal incisions met the histological acceptance criteria when compared to manual surgical incisions histology.

{2}------------------------------------------------

Cadaver eye testing was also conducted to demonstrate qualitatively the intended laser incisions can effectively cut a verity of tissue types. In this test, laser parameters, such as horizontal and vertical spot spacing, and laser pulse energy were bracketed to assess the full capability of the system. Each and all laser created corneal incisions met the qualitative acceptance criteria.

な!

{3}------------------------------------------------

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 consists of a stylized eagle with three curved lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

OptiMedica Corporation c/o Mr. Alan Marquardt Vice President of Regulatory, Clinical and Quality 1310 Moffett Park Drive Sunnyvale, CA 94089

AUG 28 2012

Re: K121091

Trade/Device Name: OptiMedica Catalys™ Precision Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: July 31, 2102 Received: August 1, 2012

Dear Mr. Marquardt:

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.

{4}------------------------------------------------

Page 2 - Mr. Alan Marquardt

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" (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 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 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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): TBD

Device Name:

Indications For Use:

OptiMedica® Catalys™ Precision Laser System

Prescription Use (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)

Daryl Kausm

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

510(k) Number K121091

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.