The MONARCH IOL Delivery System consists of two parts: an autoclavable, reusable titanium handbiece and a sterile, single-use cartridge. It is a device used for folding and delivering ACRYSOF intraocular lenses into the eye for replacement of the human crystalline lens. The system provides a controlled means to reliably place the ACRYSOF intraocular lens into the capsular bag.

AI/ML Overview

This document is a 510(k) premarket notification for the Alcon MONARCH IOL Delivery System, submitted in 1998. It describes a medical device and its intended use, rather than a study on an AI/Machine Learning device. Therefore, much of the requested information regarding acceptance criteria, study design for AI evaluation, ground truth, and expert involvement is not applicable.

However, I can extract the available information and explain why other sections are not present in this type of submission.

Applicable Information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Maintain overall diameter of the IOL	The performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the overall diameter.
Maintain haptic angle of the IOL	The performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the haptic angle.
Maintain power of the IOL	The performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the power.
Maintain resolution of the IOL	The performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the resolution.
Maintain cosmetic attributes of the IOL	The performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the cosmetic attributes.
Smooth delivery of the IOL	The test lenses were delivered smoothly.
Complete unfolding of the IOL in a controlled fashion	The test lenses unfolded completely in a controlled fashion.

Reasoning for Other Missing Information (Specific to AI/ML devices):

The provided document is a 510(k) submission for a physical medical device (an intraocular lens delivery system), not an AI/Machine Learning diagnostic or assistive tool. Therefore, the concepts of "test set," "training set," "ground truth established by experts," "MRMC studies," "standalone performance," and "data provenance" in the context of AI evaluation are not relevant to this document.

The "performance data" mentioned in the document refers to physical testing of the device's ability to handle and deliver an IOL without damage, not the performance of an algorithm.

Summary of Device and its "Study" (from the document's perspective):

Device Name: MONARCH IOL Delivery System
Intended Use: To fold and deliver Alcon ACRYSOF® intraocular lenses into the eye for replacement of the human crystalline lens.
"Study" (Performance Test): The document refers to a "performance test" that demonstrated the device's ability to deliver ACRYSOF IOLs without causing damage or affecting their critical characteristics. This is a functional and integrity test of the physical device.
Ground Truth: For this type of physical device, the "ground truth" is the established specifications and integrity of the IOLs themselves. The device is expected to deliver them without altering these pre-established qualities.
Sample Size for Test Set: Not explicitly stated, but implied to be a sufficient number of ACRYSOF IOLs to conduct the performance test.
Data Provenance: Not applicable in the context of AI/ML. The "data" here refers to the outcomes of physical testing.
Number/Qualifications of Experts: Not applicable in the context of AI/ML. The evaluation would have been conducted by engineers and quality control personnel.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not applicable (this is not an AI assistive device).
Standalone Performance: Not applicable (this is a physical delivery system, not an algorithm).
Type of Ground Truth: Physical integrity and functional performance of the IOLs post-delivery.
Sample Size for Training Set: Not applicable (no "training" in the ML sense).
How Ground Truth for Training Set was established: Not applicable.

Summary

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K 98/57/

JUL - 9 1998

LABORATORIES

ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY FORT WORTH, TEXAS 76134 -2099 (817)293-0450

May 1, 1998

510(K) SUMMARY

Submitted by:

Martin A. Kaufman Manager, Regulatory Affairs, Surgical Devices Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76132 (817) 551-8388 (Phone) (817) 551-4630 (Fax)

MONARCH IOL Delivery System Trade Name: IOL Delivery System Common Name: Classification Name: Intraocular lens Guide, 21 CFR 886.4300

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K981571

1. Predicate Device

The predicate device(s) to which we are claiming equivalence to are:

MONARCH IOL Delivery System, (Alcon Laboratories, Inc.) a.
ChiroFlex Lens Microsert, (Chiron Ophthalmics Inc.) b.
Softrans Injector, (STAAR Surgical Company) C.

2. Device Description

3. Intended Use of the Device

The intended use of this device is to fold and deliver Alcon ACRYSOF intraocular lenses into the eye for replacement of the human crystalline lens.

4. Summary of the Technological Characteristics of the Device

The MONARCH IOL Delivery System utilizes a sterile, single use cartridge and a reusable handpiece to deliver ACRYSOF lenses. The cartridge is designed for easy loading and reliable folding of ACRYSOF lenses. The handpiece accepts the cartridge and delivers the lens by using a plunger to express the lens. The plunger head is contoured to provide a good contact to the lens as well as an adequate clearance for the trailing haptic. The plunger is advanced by a screw mechanism to ensure a smooth and well controlled lens delivery.

5. Summary of the Performance Data

The performance test demonstrated that the MONARCH IOL Delivery System can be used to deliver ACRYSOF IOLs without affecting the overall diameter, haptic angle, power, resolution, or cosmetic attributes of the lenses. The test lenses were delivered smoothly and unfolded completely in a controlled fashion.

6. Conclusions

The MONARCH IOL Delivery System is easy to use, properly delivers the Alcon ACRYSOF intraocular lens, and is substantially equivalent to devices such as the Alcon MONARCH IOL Delivery System, the Softrans Injector (Model ET), or the ChiroFlex Lens Microsert system.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 1998

Mr. Martin A. Kaufman Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099

Re: K981571

Trade Name: MONARCH™ IOL Delivery System Regulatory Class: I Product Code: 86 KYB Dated: May 1, 1998 Received: May 4, 1998

Dear Mr. Kaufman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes.compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Martin A. Kaufman

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph L. Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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3. Indication for Use

510(k) Number (if known):

Device Name: MONARCH™ IOL Delivery System

Indications For Use:

The intended use of this device is to fold and deliver Alcon ACRYSOF® intraocular lenses into the eye for replacement of the human crystalline lens

(PLEASE DO NOT WRITE BELQWITHIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) . .

Lawrence Romrell
DRL

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K981571

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _

(Optional Format 1-2-96).

Regulation Number and Section

§ 886.4300 Intraocular lens guide.

(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.