(84 days)
Liquid Enzyme ID 90133 is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, or OPTI-FREE® EXPRESS® Multi-Purpose Solution. Use as recommended by your eye care practitioner.
OPTI-FREE® EXPRESS® Multi-Purpose Solution is for use in chemical (not heat) disinfection and for cleaning, rinsing, disinfecting and storing of clear and tinted, daily and extended wear soft (hydrophilic) contact lenses.
OPTI-FREE® EXPRESS® Multi-Purpose Solution can also be used as a diluent for Liquid Enzyme ID 90133.
OPTI-FREE® Rinsing, Disinfecting and Storage Solution is for use in chemical (not heat) disinfection and for rinsing, disinfecting and storing of clear and tinted, daily and extended wear soft (hydrorophilic) contact lenses.
OPTI-FREE® Rinsing, Disinfecting and Storage Solution can also be used as a diluent for Liquid Enzyme ID 90133.
Liquid Enzyme ID 90133 is a sterile, trypsin-based enzymatic cleaner buffered with sodium borate. The liquid enzymatic cleaner is formulated for one drop to be diluted in 5 mL of OPTI-FREE® or OPTI-FREE® EXPRESS® Multi-Purpose Solution. Also, this submission provides for labeling changes for OPTI-FREE® EXPRESS® Multi-Purpose Solution and OPTI-FREE® Rinsing, Disinfecting and Storage Solution to be used as diluents for Liquid Enzyme ID 90133.
The provided text describes the safety and effectiveness studies for Alcon Laboratories' Liquid Enzyme ID 90133 contact lens cleaning solution in conjunction with OPTI-FREE® Rinsing, Disinfecting and Storage Solution or OPTI-FREE® EXPRESS® Multi-Purpose Solution. However, it does not explicitly define acceptance criteria in a quantitative table format or report device performance against such criteria. The document focuses on demonstrating substantial equivalence to previously approved devices and broadly states that the product is "safe and effective".
Based on the information provided, here's what can be extracted and inferred regarding the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria are not stated, this table will reflect the types of studies conducted and their reported qualitative outcomes.
| Acceptance Criteria Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Microbiological Disinfection Efficacy | Antimicrobial activity of the disinfectant solution should not be reduced by the enzyme. | "The results demonstrate that the antimicrobial activity of OPTI-FREE® Rinsing, Disinfecting and Storage Solution is not reduced by the addition of Liquid Enzyme ID 90133 against bacteria or fungi." |
| Preclinical Toxicology & Ocular Safety | Safe for intended use; no significant acute toxicity, ocular toxicity, or irritation. | "Based on the result of these studies, Liquid Enzyme ID 90133 is safe for its intended use... and should not present an ocular hazard to the consumer..." |
| Compatibility/Cleaning Efficacy (Lab) | Device is compatible with soft contact lenses and effectively cleans laboratory-deposited lenses. | "The studies demonstrated the compatibility and cleaning efficacy of the Liquid Enzyme ID 90133/OPTI-FREE® EXPRESS® Multi-Purpose Solution regimen." |
| Clinical Safety & Efficacy | Safe and effective for daily simultaneous enzymatic cleaning and disinfection of soft contact lenses in a clinical setting. | "This clinical study demonstrated the Liquid Enzyme ID 90133/OPTI-FREE® EXPRESS® Multi-Purpose Solution regimen is safe and effective for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses." |
2. Sample Size Used for the Test Set and Data Provenance
- Microbiological Studies: Not explicitly stated, but implies sufficient samples were used to meet FDA guidelines for contact lens solutions. Data provenance is implied to be laboratory-based testing following FDA guidelines.
- Preclinical Toxicology: Not explicitly stated for each test, but "Comprehensive preclinical toxicology tests have been conducted." Data provenance is laboratory-based.
- Compatibility/Cleaning Efficacy: Not explicitly stated, but implies sufficient samples of "laboratory deposited lenses" were used. Data provenance is laboratory-based.
- Clinical Study: 100 patients/200 eyes for a 3-month duration. Data provenance is clinical (human subjects). The country of origin is not specified but is likely the US given the FDA submission. This was a prospective study.
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 document. The studies described are primarily laboratory and clinical performance assessments, not expert consensus tasks for establishing ground truth in the sense of classification or diagnosis.
4. Adjudication Method (for the test set)
- This information is not provided as the studies are not based on subjective assessment by multiple experts requiring adjudication. For the clinical study, the assessment of safety and effectiveness would have been based on objective measures and clinical observations.
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
- No, an MRMC comparative effectiveness study was not done. This document pertains to a chemical solution for contact lenses, not an AI or imaging device involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a chemical product, not an algorithm.
7. The Type of Ground Truth Used
- Microbiological Studies: Ground truth would be defined by standard microbiological culture techniques and quantitative measurements of microbial reduction/survival, as per FDA guidelines. This is objective laboratory data.
- Preclinical Toxicology: Ground truth would be based on established toxicology protocols, histopathological examination, and clinical observations in animal models (e.g., irritation, acute toxicity). This is objective laboratory data.
- Compatibility/Cleaning Efficacy: Ground truth would be based on objective measures of lens integrity, protein/lipid removal, and physical characteristics of the lenses after treatment. This is objective laboratory data.
- Clinical Study: Ground truth for safety would be adverse event reporting, slit-lamp examination findings, and other clinical observations. Ground truth for efficacy would be based on objective measures of lens cleanliness and patient-reported outcomes over the 3-month period. This is clinical observation and patient outcomes data.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This document does not describe a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this document does not describe a machine learning or AI model.
§ 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.”