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") is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, 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 2[patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus).

AI/ML Overview

This document describes the Catalys Precision Laser System, an ophthalmic surgical laser. The information provided heavily emphasizes bench and cadaver testing for the patient interface component and system functionality, rather than presenting a clinical study involving human patients with clear acceptance criteria and performance metrics typically found in AI/ML device submissions.

Therefore, many of the requested items (e.g., acceptance criteria for clinical performance, sample size for test set with human data, number of experts for ground truth, MRMC study, training set details) cannot be extracted from the provided text. The text focuses on engineering and bench testing to demonstrate design verification and validation for minor design changes to an existing device, not on demonstrating clinical performance of an AI/ML algorithm.

However, I can extract information related to the bench and cadaver testing that was performed.

Here's the closest possible interpretation of your request based on the provided text, focusing on the available information regarding testing:

Device: Catalys Precision Laser System (Ophthalmic Laser)

Purpose of Submission (K170322): This 510(k) submission is for minor design changes to the Patient Interface Component (Liquid Optics Interface - LOI) of an already cleared predicate device (Catalys Precision Laser System; K161455). The study aims to demonstrate that the redesigned LOI, and the system as a whole with the updated LOI, continues to meet intended design specifications and performs as intended.

Acceptance Criteria and Reported Device Performance (based on Bench and Cadaver Testing):

Acceptance Criteria Category (Implied from Testing)	Specific Test/Evaluation	Reported Performance (Summary from Text)
Functional Verification (LOI & System)	Installation of LOI onto Catalys system	Verified functional requirements for the subject device as a complete assembly with the system.
Sub-assembly Testing (LOI components)	Disposable lens, suction ring, fluid reservoir subassemblies	Functional requirements successfully met on a sub-assembly level.
Design Validation (LOI & System with Software)	Functionality with Catalys System and cOS 3.90 software	Validated subject device requirements and its functionality.
Cadaver Eye Model Performance	Eye fit	Product continues to perform as intended.
	Intraocular pressure rise at the eye	Product continues to perform as intended.
	Suction ring's ability to maintain vacuum and seal when attached to the eye	Product continues to perform as intended.
Packaging Integrity	Packaging validation	Meets requirements for maintaining sterile barrier integrity, product functionality, and labeling.
Shelf-Life	Shelf-life testing	Successfully performed to verify and validate the shelf life of the subject device and associated packaging.
Laser Incision Delivery	(Implicitly, as design changes are to LOI, not laser engine)	"Bench testing demonstrated that subject device with the Catalys system continues to deliver incisions as intended." (Relies on prior K161455 data for detailed laser performance).

Study Details (for this 510k submission, K170322):

Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: Not explicitly quantified in terms of "sample size" for a dataset, but multiple functional tests, sub-assembly tests, and design validation tests were performed. The "test set" here refers to the physical units/components under evaluation.
- Cadaver Eye Model Testing: Not explicitly quantified in terms of number of cadaver eyes, but performed to demonstrate performance.
- Data Provenance: The location of the testing is not specified, but the applicant (OptiMedica Corporation) is based in Milpitas, CA, USA. The testing appears to be prospective in the sense that it was conducted specifically for this submission to verify new design changes.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of clinical AI/ML ground truth. The "ground truth" for this device's performance is established by engineering specifications, functional requirements, and physical measurements/observations during bench and cadaver testing. The experts involved would be engineers and technical personnel conducting the tests.
Adjudication Method for the Test Set:
- Not applicable. This testing is focused on objective engineering performance and physical verification, not subjective human interpretations requiring adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is relevant for diagnostic imaging AI/ML devices where human readers' performance is being evaluated with and without AI assistance. This submission is for a surgical laser device and its physical components.
If a Standalone Performance Study Was Done (Algorithm Only Without Human-in-the-Loop Performance):
- Not applicable in the AI/ML sense. The "algorithm" (software for the laser system) is integrated and operates the device. The testing described focuses on the device's physical performance, not on a standalone AI algorithm's diagnostic accuracy. The text does state that "Bench testing of the predicate device (resident in K161455) with regards to the ability to deliver a variety of laser patterns intended for capsulotomy, phacofragmentation and corneal incisions with corresponding accuracy and precision is directly applicable to the subject device as there are no significant changes to the subject device other than the design changes made to the LOI." This implies that the core laser control "algorithm" was validated previously.
The Type of Ground Truth Used:
- Engineering Specifications / Design Requirements: The primary ground truth for the device's performance. Tests confirm that the device meets its predefined functional and performance specifications.
- Physical Measurements/Observations: During bench testing (e.g., maintaining vacuum, sterile barrier integrity).
- Cadaver Eye Performance: Demonstrating that the system functions as intended with biological tissue regarding physical interactions (eye fit, pressure, seal).
The Sample Size for the Training Set:
- Not applicable. This submission is not for an AI/ML algorithm that requires a "training set" in the conventional machine learning sense. The device's operation is based on pre-programmed designs and physical principles, not on learned patterns from a dataset.
How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set was used.

In summary, the provided document details the verification and validation of minor design changes to a surgical laser system's physical components through bench and cadaver testing, rather than the clinical evaluation of an AI/ML algorithm for diagnostic purposes.

Summary

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

May 19, 2017

Abbott Medical Optics Inc. Audrev Munnerlyn Senior Director, Regulatory Affairs 510 Cottonwood Drive Milpitas, CA 95035

Re: K170322

Trade/Device Name: Catalys Precision Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: April 7, 2017 Received: April 10, 2017

Dear Audrey Munnerlyn:

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.

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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 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:	K170322
Device Name:	Catalys Precision Laser System
Indications for Use:	The OptiMedica Catalys Precision Laser System is indicatedfor use in patients undergoing cataract surgery for removalof the crystalline lens. Intended uses in cataract surgeryinclude anterior capsulotomy, phacofragmentation, and thecreation of single plane and multi-plane arc cuts/incisions inthe cornea, each of which may be performed eitherindividually or consecutively during the same procedure.

Prescription Use X (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)

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510(k) Summary - K170322

The following 510(k) summary for K170322 is submitted in accordance with the requirements of 21 CFR 807.92:

Applicant

OptiMedica Corporation (A subsidiary of Abbott Medical Optics Inc.) 510 Cottonwood Drive Milpitas, CA 95035 Phone: 408.733.2020

Contact Person

Audrey Munnerlyn Senior Director, Regulatory Affairs Abbott Medical Optics Inc., 510 Cottonwood Drive Milpitas, CA 95035 Phone: +1 408.273.4106 Fax: +1 408.273.5966 Email: audrey.munnerlyn@abbott.com

Date Prepared

30 Jan 2017

Classification

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

Trade Name

Catalys 2 Precision Laser System

Predicate Devices

Catalys Precision Laser System; K161455, cleared 20 Sep 2016

Intended Use

The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in

1 CATALYS, OPTIMEDICA and LIQUID OPTICS are trademarks owned by or licensed to Abbott Medical Optics Inc., its subsidiaries or affiliates.

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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

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 4 lasers per ANSI Z136.1-2007.

Substantial Equivalence

The Catalys Precision Laser System is substantially equivalent to the predicate device (as cleared via K161455) in terms of indications for use, technological characteristics and fundamental scientific technology. The mechanism of laser cutting is the same for both 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.

As compared to the predicate device, the subject device has an updated version of the Liquid Optics Interface (LOI). The subject device now consists of an additional vacuum line specifically reserved for the purpose of vacuum sensing, thereby providing a faster means of detecting suction loss between the patient's eye and the System. Additionally, the profile of the Suction ring component of the suction ring has been slimmed. Finally, the volume of the fluid reservoir component of the subject device has been increased.

2 CATALYS, OPTIMEDICA and LIQUID OPTICS are trademarks owned by or licensed to Abbott Medical Optics Inc., its subsidiaries or affiliates.

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Summary of Bench and Animal Performance Testing

Bench testing related to the patient interface component (LOI) of the Catalys Laser System was conducted to demonstrate the LOI and the System's ability to meet all intended design specifications related to the subject device design changes. The following testing was performed to verify the requirements related to the subject device design changes:

. Functional Verification bench testing was performed by installing the LOI onto a Catalys system to verify the functional requirements for the subject device as a complete assembly with the system
Sub-assembly testing was performed to verify that the subject device functional requirements were successfully met on a sub-assembly level which included the disposable lens, suction ring and the fluid reservoir subassemblies
Design validation was performed to validate the subject device requirements and it's functionality with the Catalys System with cOS 3.90 software
Subject device functionality testing was also performed with a cadaver eye model to demonstrate that the product continues to perform as intended with regards to the eye fit, intraocular pressure rise at the eye and the suction ring's ability to maintain vacuum and seal when attached to the eye

In addition, packaging validation was conducted to verify the integrity and product functionality of the subject device packaging configuration. Testing demonstrated that the packaging meets the requirements for maintaining sterile barrier integrity, product functionality and labeling. Also, shelf-life testing was successfully performed to verify and validate the shelf life of the subject device and its associated packaging system. Overall, bench testing demonstrated that subject device with the Catalys system continues to deliver incisions as intended. Bench testing of the predicate device (resident in K161455) with regards to the ability to deliver a variety of laser patterns intended for capsulotomy, phacofragmentation and corneal incisions with corresponding accuracy and precision is directly applicable to the subject device as there are no significant changes to the subject device other than the design changes made to the LOI.

The bench testing provided in K161455, when coupled with the bench and cadaver testing presented for the subject device provided in this submission, provide reasonable assurance that the system is safe and effective for its intended use and furthermore, that it is substantially equivalent to the identified 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.