For use in the daily cleaning, removing protein deposits, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye practitioner.

For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

OPTI-ONE® Multi-Purpose Solution can be used to dissolve OPTI-ZYME® Enzymatic Cleaning Tablets.

Device Description

OPTI-ONE® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution containing borates, citrates, mannitol, and sodium chloride with PATONIC® and TETRONIC® surfactants, and edetate disodium 0.05% and POLYQUAD® (polyquaternium-1) 0.001% preservatives.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a contact lens care solution, focusing on protein removal. However, it does not detail acceptance criteria in a quantitative manner, nor does it provide the specifics of a study in the format requested (e.g., sample sizes, expert qualifications, adjudication methods for ground truth, MRMC studies, or standalone algorithm performance).

The information provided largely focuses on demonstrating substantial equivalence to a predicate device and a new claim for protein removal, rather than a detailed technical performance evaluation against specific quantitative acceptance criteria.

Therefore, much of the requested information cannot be extracted from the given document.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Protein Removal (General, implicit)	"significantly more protein was removed from both human-worn and laboratory deposited Group IV lenses by OPTI-ONE Multi-Purpose Solution than by ReNu MultiPlus Multi-Purpose Solution."
Substantial Equivalence to Predicate Device (Bausch & Lomb ReNu MultiPlus™ Multi-Purpose Solution) for existing indications and actions	Claimed and accepted by FDA for existing actions and indications.
Compliance with FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products	Stated as meeting these guidelines.
Sterility, pH, isotonicity, chemical composition as described	Implicitly met to support safety and effectiveness. (No specific values provided)
Cleaning capabilities (general)	Implicitly met for daily cleaning claim.
Chemical disinfection capabilities (general)	Implicitly met for chemical disinfection claim.
Storage capabilities (general)	Implicitly met for storage claim.
Diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover	Claimed and accepted for this use.
Dissolution of OPTI-FREE® and OPTI-ZYME® Enzymatic Cleaning Tablets	Claimed and accepted for this use.

Missing from the document regarding acceptance criteria:

Specific quantitative thresholds for "significantly more protein removed."
Any other specific, quantitative acceptance criteria for cleaning, disinfection, storage, or safety beyond the general claim of superiority in protein removal for certain lens types and substantial equivalence.

2. Sample sizes used for the test set and the data provenance:

Sample Size (Test Set): Not specified. The document only mentions "Group I and IV human-worn and laboratory deposited lenses." It does not provide the number of lenses or subjects used in these tests.
Data Provenance: The document implies laboratory studies and human-worn lens studies, but does not specify the country of origin of the data. It is a prospective study as tests were conducted to support a new claim.

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

Not applicable. This device is a contact lens solution, and the "ground truth" here relates to objective biochemical measurements (protein removal) rather than expert interpretation of images or patient data. No experts for ground truth establishment were mentioned or would typically be used in this context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. As above, the evaluation is based on objective laboratory measurements for protein removal, not subjective interpretations requiring adjudication.

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:

Not applicable. This is a chemical solution, not an AI-powered diagnostic device. An MRMC study is irrelevant to this product.

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

Not applicable. This is a chemical solution, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the protein removal claim was based on objective laboratory measurements of protein removed from lenses (both human-worn and laboratory-deposited). This would involve analytical chemistry techniques to quantify protein levels.

8. The sample size for the training set:

Not applicable. This product is a chemical solution, not a machine learning model, so there is no concept of a "training set."

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

Not applicable. As there is no training set for a chemical solution, this information is not relevant.

Summary

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DEC 1 8 1998

DRAFT 510(K) SUMMARY

Submitted by:

Michael Pfleger Director, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 551-4877 (Phone) (817) 551-4630 (Fax)

Device Name:

Contact Lens Care Multi-Purpose Solution Common Name: OPTI-ONE® Multi-Purpose Solution Proprietary Name:

Indications for Use:

For use in the daily cleaning, removing protein deposits, chemical (not heat) disinfection and storage of chemical (not heat) disinfection soft (hydrophilic) contact lenses as recommended by your eye practitioner.

For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

OPTI-ONE® Multi-Purpose Solution can be used to dissolve OPTI-FREE® and OPTI-ZYME® Enzymatic Cleaning Tablets.

Description:

Substantial Equivalence:

OPTI-ONE® Multi-Purpose Solution is substantially equivalent, in terms of its actions and indications for use, to Bausch & Lomb ReNu MultiPlus™ Multi-Purpose Solution, cleared for marketing under PMA P860023/S12 and 510(k) K974723. OPTI-ONE Multi-

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Purpose Solution meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.

Safety and Effectiveness:

Group I and IV human-worn and laboratory deposited lenses were soaked in OPTI-ONE Multi-Purpose Solution or ReNu MultiPlus™ Multi-Purpose Solution and were compared for protein removal. Statistical analysis of the data showed that significantly more protein was removed from both human-worn and laboratory deposited Group IV lenses by OPTI-ONE Multi-Purpose Solution than by ReNu MultiPlus Multi-Purpose Solution. These studies demonstrate that OPTI-ONE Multi-Purpose Solution continues to remove protein while lenses are stored.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its head, representing the department's mission to promote health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 1998

Mr. Michael E. Pfleger Director, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099

Re: K983973 Trade Name: OPTI- ONE ® Multi-Purpose Solution (adding a protein removal claim) Regulatory Class: II Product Code: 86 LPN Dated: November 6, 1998 Received: November 9, 1998

Dear Mr. Pfleger:

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 (OS) 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. Michael E. Pfleger

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 Roerl 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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510(k) Number (if known):_K983973

Device Name: OPTI-ONE® Multi-Purpose Solution

Indications for Use:

For use in the daily cleaning, removing protein deposits, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye practitioner.

For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

OPTI-ONE® Multi-Purpose Solution can be used to dissolve OPTI-ZYME® Enzymatic Cleaning Tablets.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

Eis G

(Division Sign-Off)

on of Ophthalmic Devices K983973 5100k) Number

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”