OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens or rigid gas permeable (silicone acrylate and fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in OPTI-FREE® EXPRESS Multi-Purpose Solution, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE® Bolution, Or ITT FRD - Icansing, Diomisoning and Stering Colution or conditioned in OPTI-SOAK® Conditioning Solution. Use as recommended by your eye care practitioner.

Device Description

OPTI-FREE® SUPRACLENS® Daily Protein Remover is a preservative-free solution which contains propylene glycol, sodium borate, and highly purified porcine pancreatin enzymes as the active cleaning ingredient.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria, formatted as requested:

Device: OPTI-FREE® SUPRACLENS® Daily Protein Remover
Context: 510(k) Premarket Notification (K990480)

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several aspects of performance and safety, but it does not present explicit, quantitative acceptance criteria with corresponding performance metrics in a clear, tabulated format. Instead, it describes studies and concludes that the device "meets FDA criteria," "is not cytotoxic," "ocular effects... were of no clinical significance," and "provides clinically equivalent cleaning."

Below is an attempt to synthesize the information into a table, inferring "acceptance criteria" from the described outcomes.

Aspect Evaluated	Implied Acceptance Criteria (from FDA Guidelines/Clinical Significance)	Reported Device Performance
Non-Clinical Data
Disinfection Efficacy	Meets FDA guidelines for contact lens solutions disinfection efficacy	Meets FDA criteria for disinfection of contact lenses
Cytotoxicity	Not cytotoxic in agar overlay assay	Not cytotoxic in the agar overlay assay
Ocular Irritation (14-day study)	Ocular effects should be minimal and of no clinical significance	Ocular effects were generally confined to the conjunctiva, minimal in nature, and judged to be of no clinical significance
Cleaning Efficacy	Satisfactorily cleans laboratory deposited lens	Satisfactorily cleans deposits commonly found on hydrophilic contact lenses
Product Compatibility	Compatible with hydrophilic soft contact lenses (Groups I-IV)	Compatibility demonstrated with hydrophilic soft contact lenses (Groups I-IV)
Clinical Data
Clinical Cleaning Efficacy	Clinically equivalent cleaning compared to historical control	Provides clinically equivalent cleaning compared to historical control regimen in maintaining visibly clean lenses
Overall Clinical Acceptability	Clinically acceptable for all efficacy variables	Clinically acceptable as measured by: lens replacements, patient convenience and comfort, corrected visual acuity, and lens wearing time
Serious Adverse Events	No serious adverse events related or unrelated to the regimen	No serious adverse events related or unrelated to the regimen were reported
Intolerance Incidence	Clinically equivalent to historical control regimen	Incidence of intolerance (3.2%) was clinically equivalent to historical control (2.0%)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Study): 62 patients / 124 eyes
Data Provenance: The document does not explicitly state the country of origin. The submission is to the US FDA, so it's reasonable to infer the study was conducted in the US or under US regulatory standards, but this is not explicitly stated.
Retrospective or Prospective: Prospective. The clinical study was "a three-month, open-label, multi-site study with a descriptive control," indicating a planned, forward-looking design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study. It mentions the study evaluated "clinically clean" lenses and "efficacy variables," which would typically involve expert assessment, but the specifics are not given. For the non-clinical studies (microbiological, cytotoxicity, ocular irritation), the "ground truth" is based on standard scientific assay results and interpretations rather than expert consensus in the same way a clinical image might be.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the clinical study. It mentions a "descriptive control" and evaluation of "efficacy variables," suggesting direct assessment by investigators rather than an independent adjudication panel for potentially ambiguous cases.

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

There is no mention of a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The clinical study compares the new regimen to a "historical control regimen" (OPTI-FREE® SUPRACLENS® Daily Protein Remover/ OPTI-FREE® Rinsing. Disinfection and Storage Solution/OPTI-FREE® Daily Cleaner), but it's not structured as an MRMC study designed to assess reader improvement with or without AI assistance. The device is a cleaning solution, not an AI diagnostic tool.

6. Standalone Performance Study

The reported studies (non-clinical and clinical) evaluate the performance of the product (OPTI-FREE® SUPRACLENS® Daily Protein Remover in combination with Bausch & Lomb ReNu® Multi-Purpose Solution). Since this is a contact lens care product, not an algorithm or AI, the concept of "standalone (i.e., algorithm only without human-in-the-loop performance)" is not applicable. The product's performance is its standalone performance within the context of its indicated use.

7. Type of Ground Truth Used

Non-Clinical Studies:
- Microbiological: Standard FDA guidelines for disinfection efficacy (laboratory-based measurements).
- Cytotoxicity: Agar overlay assay results (laboratory-based measurements).
- Ocular Irritation: Observational findings in rabbits by qualified personnel (pre-clinical animal model).
- Cleaning Efficacy: Laboratory-deposited lens cleaning assessment (objective laboratory-based assessment).
Clinical Study:
- Clinical assessment of "visibly clean" lenses, lens replacements, patient convenience and comfort, corrected visual acuity, lens wearing time, and incidence of intolerance. This combines objective measures with subjective patient reports and clinical observations by investigators.

8. Sample Size for the Training Set

The document describes studies for a marketed product (cleaning solution), not an AI algorithm. Therefore, there is no concept of a "training set" as understood in machine learning. The studies conducted are for performance validation rather than model training.

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

As explained in point 8, the concept of a "training set" is not applicable here as this is not an AI/algorithm-based device.

Summary

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MAY 1 0 1999

K990480

May 3, 1999

Image /page/0/Picture/3 description: The image shows the logo for Alcon Laboratories. The word "Alcon" is written in large, bold, black letters. Below the word "Alcon" is the word "LABORATORIES" written in smaller, black letters. The logo is simple and easy to read.

510(K) SUMMARY

Submitted by:

Ralph H. Larsen Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 551-4702 (Phone) (817) 551-4630 (Fax)

Device Name:

Contact Lens Cleaning Solution Common Name:

OPTI-FREE® SUPRACLENS® Daily Protein Remover Proprietary Name:

Indications for Use:

Description:

Substantial Equivalence:

This product is substantially equivalent, in terms of its actions and indications for use, to Alcon OPTI-FREE® SUPRACLENS® Daily Protein Remover (PMA 820001/S18, K974625). OPTI-FREE® SUPRACLENS® Daily Protein Remover 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.

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Safety and Effectiveness:

A. Non-Clinical Data

Microbiological Studies

The combination OPTI-FREE® SUPRACLENS® Daily Protein Remover in Bausch & Lomb ReNu Multi-Purpose Solution was evaluated for disinfection efficacy using the FDA guidelines for contact lens solutions. The OPTI-FREE® SUPRACLENS® Daily Protein Remover in Bausch & Lomb ReNu® Multi-Purpose Solution regimen meets the FDA criteria for disinfection of contact lenses.

Preclinical

Since both OPTI-FREE® SUPRACLENS® Daily Protein Remover and Bausch & Lomb ReNu Multi-Purpose Solution have been shown to be safe in FDAaccepted toxicology studies, the preclinical safety evaluation in this submission focused on the cytotoxicity and ocular safety of the products when used together in a soft contact lens care regimen. The cytotoxicity evaluation demonstrated that OPTI-FREE® SUPRACLENS® Daily Protein Remover used with ReNu® Multi-Purpose Solution is not cytotoxic in the agar overlay assay. The fourteen-day ocular irritation evaluation in rabbits of OPTI-FREE® SUPRACLENS® Daily Protein Remover when used with ReNu® Multi-Purpose Solution for the daily simultaneous cleaning and disinfection of soft contact lenses demonstrated that the ocular effects produced were generally confined to the conjunctiva, minimal in nature and were judged to be of no clinical significance.

Based on the result of these studies, OPTI-FREE® SUPRACLENS® Daily Protein Remover is safe for its intended use with Bausch & Lomb ReNu® Multi-Purpose Solution in the simultaneous cleaning and disinfection of soft (hydrophilic) contact lenses (Groups I-IV) and should not present an ocular hazard to the consumer under the recommended lens treatment regimen.

Compatibility/Cleaning Efficacy

Product compatibility with soft contact lenses and the product's ability to clean laboratory deposited lens were evaluated. The cleaning study demonstrated the ability of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/ Bausch & Lomb ReNu Multi-Purpose Solution regimen to satisfactorily clean deposits commonly found on hydrophilic contact lenses. Also, compatibility of the regimen was demonstrated with hydrophilic soft contact lenses (Groups ) through IV) when used daily to concurrently clean and disinfect lenses.

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B. Clinical

A clinical study was conducted and demonstrated that the OPTI-FREE® SUPRACLENS® Daily Protein Remover/ Bausch & Lomb ReNu® Multi-Purpose Solution regimen is safe and effective for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses. The study was a three-month, open-label, multi-site study with a descriptive control. The descriptive control was OPTI-FREE® SUPRACLENS® Daily Protein Remover/ OPTI-FREE® Rinsing. Disinfection and Storage Solution/OPTI-FREE® Daily Cleaner. Patients wearing soft (hydrophilic) contact lenses from lens polymer groups I and IV were enrolled on a daily wearing schedule. There were 62 patients/124 eyes. The OPTI-FREE® SUPRACLENS® Daily Protein Remover/ Bausch & Lomb ReNu Multi-Purpose Solution regimen provides clinically equivalent cleaning compared to the historical control regimen in maintaining clinically clean (i.e., visibly clean) lenses. The OPTI-FREE® SUPRACLENS® Daily Protein Remover/ Bausch & Lomb ReNu® Multi-Purpose Solution regimen is clinically acceptable as measured by all efficacy variables including: lens replacements, patient convenience and comfort, corrected visual acuity and lens wearing time. No serious adverse events related or unrelated to the regimen were reported. The incidence of intolerance to the regimen (3.2%) was clinically equivalent to the incidence of intolerance associated with the historical control regimen (2.0%).

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 1999

Mr. Ralph H. Larsen Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099

Re: K990480

Trade Name: OPTI-FREE® SURPRACLENS® Daily Protein Remover (For use of Bausch & Lomb ReNu® Multi-Purpose Solution as a diluent, indicated for simultaneous enzymatic cleaning and disinfection) Regulatory Class: II Product Code: 86 LPN Dated: February 12, 1999 Received: February 16, 1999

Dear Mr. Larsen:

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 vour 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. Ralph H. Larsen

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 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): _________

Device Name: OPTI-FREE® SUPRACLENS® Daily Protein Remover

Indications for Use:

OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens or rigid gas permeable (silicone acrylate and fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® EXPRESS® Multi-Purpose Solution, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE® Multi-Purpose Solution, Bausch & Lomb ReNu® Multi-Purpose Solution or conditioned in OPTI-SOAK® Conditioning Solution.. Use as recommended by your eye care practitioner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Inn Sion-Off sion of Ophthalmic Devices 1990480 (k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

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.”