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

OPTI-FREE® EXPRESS® Multi-Purpose Disinfecting Solution can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Device Description

OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, TETRONIC® 1304, with edetate disodium 0.05%, POLYQUAD® (polyquaternium-1) 0.001% and ALDOX™ (myristamidopropyl dimethylamine) 0.0005% as preservatives.

AI/ML Overview

The provided text describes a 510(k) submission for a contact lens care solution, not a device that involves AI or human interpretation of images/data. Therefore, many of the requested categories (like sample size for test/training sets, experts, adjudication method, MRMC studies, standalone performance in the context of algorithms, and ground truth types related to medical images) are not applicable.

However, I can extract the acceptance criteria and study information relevant to the product's performance as a contact lens disinfecting solution.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Guidance	Reported Device Performance (OPTI-FREE EXPRESS MPS)
Microbiology (Disinfection)	FDA Guidelines / ISO 14729:2001 Regimen Test Requirements	Met both FDA guidelines and ISO 14729:2001 Regimen Test Requirements for various regimens.
	Stand Alone Test (ISO 14729 / FDA 510[k])	Met primary criteria; organic soil had no deleterious effect on antimicrobial activity. (K001214)
	Regimen Test (ISO 14729 / FDA 510[k])	Met criteria using previous approved labeling and a new investigational regimen (less rinsing). (K001214 & new study)
Cleaning (Protein Removal)	Demonstrated ability to clean lenses / remove protein	Demonstrated ability to clean lenses during soaking. Showed superiority over Bausch & Lomb's ReNu Multi-Plus® Multi-Purpose Solution in removing protein (lysozyme) from Group IV lenses.
Safety & Efficacy (Clinical)	Demonstrate safety and efficacy in a clinical setting.	Demonstrated safety and efficacy with a rinse/soak regimen in a 30-day clinical study.
Biocompatibility	FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products	Meets these guidelines. No new biocompatibility testing required for a labeling change as the product formulation remains unchanged.

2. Sample size used for the test set and the data provenance

Microbiology Studies: Not explicitly stated as a number of lenses or microbial samples, but the studies were conducted to meet FDA guidelines and ISO 14729:2001 standards, which typically involve specific sample sizes for microbial challenges.
Cleaning Studies: Not explicitly stated.
Clinical Study: No specific sample size provided, only described as a "30-day, randomized concurrently controlled, observer-masked... and patient-masked, parallel group, multi-site study."
Data Provenance: The studies were conducted by Alcon Research, Ltd. for internal verification and submission to the FDA. The nature of the studies implies prospective data collection for the specific purpose of regulatory submission. The country of origin of the data is not explicitly stated but implies US-based studies due to FDA submission.

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

This is not applicable to a contact lens care product. Ground truth in this context would be laboratory measurements of microbial count reduction, protein removal, and clinical observations of safety and efficacy. These are quantified metrics, not expert consensus on interpretations. One of the studies was "observer-masked (investigator and chemical analyst)," implying experts were involved in data collection and analysis, but not for establishing a subjective "ground truth."

4. Adjudication method for the test set

This is not applicable as the studies are focused on quantifiable measurements (e.g., microbial kill, protein levels) rather than 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

This is not applicable to a contact lens care product. There is no "human reader" or "AI assistance" involved in its intended use.

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

This is not applicable to a contact lens care product. There is no algorithm. However, the document does mention "Stand Alone Test" in the context of antimicrobial activity, referring to a specific laboratory test method (ISO 14729) for the product's disinfection ability without any additional steps. This is a "standalone" test of the product's inherent capacity, not an algorithm's.

7. The type of ground truth used

Microbiology Studies: Lab-based quantitative assays measuring microbial reduction (kill rates) for specific microorganisms.
Cleaning Studies: Lab-based quantitative assays measuring protein (lysozyme) levels on contact lenses.
Clinical Study: Objective measures of safety (e.g., adverse events, corneal health assessments) and efficacy (e.g., continued comfortable wear, absence of infection, potentially protein measurement as noted in cleaning).

8. The sample size for the training set

This is not applicable as there is no AI algorithm being trained for this product.

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

This is not applicable as there is no AI algorithm being trained for this product.

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K Number

K002589

Device Name

OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

Manufacturer

ALCON UNIVERSAL, LTD.