(78 days)
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
OPTI-ONE® Multi-Purpose Solution (modified directions for use) can also be as a d:luent for OPTI-ZYME® Enzymatic Cleaner.
OPTI-ONE® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution, containing borates, citrate, mannitol, and sodium chloride with Pationic® and Tetronic® surfactants and edetate disodium 0.05% and POLYQUAD® (polyquaternium-1) 0.0011% preservatives.
The provided 510(k) summary for K031193, OPTI-ONE® Multi-Purpose Solution, focuses on demonstrating substantial equivalence to a predicate device and adherence to FDA guidelines for contact lens care products. While some study details are mentioned, it primarily summarizes the findings rather than providing in-depth study protocols and results with specific acceptance criteria and performance metrics in a structured format often seen in clinical trial reports.
Here's an analysis based on the provided text, addressing the requested information to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format for its clinical study. Instead, it makes a general statement about clinical acceptability and similarity to the control. For the microbiology study, it references FDA guidelines and ISO 14729:2001 requirements as the acceptance criteria.
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cleaning Studies | (Implicit) Ability to effectively clean laboratory deposited lenses using a no-rub regimen. | Demonstrated ability to clean laboratory deposited lenses. |
| Microbiology Studies | Meets FDA guidelines for Regimen Test. Meets ISO 14729:2001 Regimen Test Requirements. | OPTI-ONE® Multi-Purpose Disinfecting Solution evaluated by the test regimen meets FDA guidelines and ISO 14729:2001 Regimen Test Requirements. |
| Clinical Study | Clinically acceptable performance for safety and efficacy. Similar to Bausch & Lomb ReNu MultiPlus® Multi-Purpose Solution (control). | The efficacy of OPTI-ONE® Multi-Purpose Solution (modified directions for use) is clinically acceptable and similar to Bausch & Lomb ReNu MultiPlus® Multi-Purpose Solution used according to its approved label. |
2. Sample Size Used for the Test Set and Data Provenance
- Cleaning Studies: The sample size for the cleaning study is not specified. The data provenance is implied to be a "laboratory study," suggesting it was conducted in a controlled environment, likely in the US, but this is not explicitly stated. It's retrospective in the sense that the lenses were "laboratory deposited."
- Microbiology Studies: The sample size for the microbiology study is not specified. The data provenance is implied to be a "study" conducted in a laboratory, likely in the US.
- Clinical Study: The sample size for the clinical study is not specified, only that it was a "90-day clinical study." The data provenance is a "clinical study," implying prospective human subject data, likely from the US, but the country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. For studies involving contact lens care products, "ground truth" might refer to:
- Cleaning Studies: The standard or method for assessing the level of laboratory-deposited debris removal. This would typically be assessed by laboratory technicians or validated instrumental methods, not clinical experts.
- Microbiology Studies: The standard microbiological methods for quantifying microbial reduction. Experts would be microbiologists or laboratory personnel.
- Clinical Study: Clinical outcomes (e.g., adverse events, comfort, visual acuity, lens condition). These would be assessed by eye care practitioners, such as optometrists or ophthalmologists. However, the exact number and qualifications are not mentioned.
4. Adjudication Method for the Test Set
This information is not provided in the summary. Clinical studies often employ adjudication for subjective endpoints or adverse events.
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 section is not applicable. The device is a contact lens care solution, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to readers improving with AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device is a chemical solution, not an algorithm. Its performance is inherent to the solution itself when used with contact lenses.
7. The Type of Ground Truth Used
- Cleaning Studies: Laboratory-deposited lenses (simulated dirt/debris) and likely an objective assessment of cleanliness.
- Microbiology Studies: Reduction of specified microorganisms as per FDA and ISO standards (laboratory-based microbiological assays).
- Clinical Study: Safety and efficacy outcomes, likely including clinical examinations, patient surveys/feedback on comfort, and documented adverse events. The control used was Bausch & Lomb ReNu MultiPlus®.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. A "training set" typically refers to data used to train machine learning models. This device is a chemical solution assessed through laboratory and clinical studies, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and not applicable for the same reasons as point 8.
Summary of Limitations:
The provided 510(k) summary is typical for a medical device product like a contact lens solution, which focuses on demonstrating safety and efficacy through laboratory and clinical studies. It highlights substantial equivalence to a predicate device and compliance with relevant guidelines. However, it lacks the detailed methodological and quantitative information (e.g., precise sample sizes, specific quantitative acceptance criteria values, expert qualifications, and adjudication methods) that would be expected in a full clinical study report, especially for AI/ML-driven devices. The nature of the device (a chemical solution) means many of the requested points related to AI/ML performance (MRMC, standalone algorithm, training sets) are not relevant.
§ 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.”