(83 days)
OPTI-FREE® SUPRACLENS® Daily Protein Remover 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 Alcon Multi-Purpose Disinfecting Solution ID 90746, OPTI-FREE Rinsing, Disinfection and Storage Solution, OPTI-FREE EXPRESS Multi-Purpose Solution or OPTI-ONE Multi-Purpose Solution. Use as recommended by your eye care practitioner.
OPTI-FREE® SUPRACLENS® Daily Protein Remover is a sterile, preservative-free aqueous suspension, containing pancreatin as the active cleaning agent.
This document describes the acceptance criteria and supporting studies for the OPTI-FREE® SUPRACLENS® Daily Protein Remover.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Microbiological Safety & Effectiveness | Meet FDA Stand-Alone criteria for disinfection against bacteria, yeast, and mold during simultaneous enzymatic cleaning and disinfection. | "The formulation meets the Stand-Alone criteria for disinfection of contact lens against bacteria, yeast and mold." | Non-Clinical: Microbiological Studies |
| Preclinical Toxicology | Demonstrate safety for use in cleaning all soft (hydrophilic) contact lenses (Group I, II, III, and IV). | "Preclinical toxicology tests have been conducted to substantiate the safety of the product for use in cleaning, of all soft (hydrophilic) contact lens (Group I, II, III, and IV)." Specific tests included cytotoxicity (agar overlay) and ocular safety (irritation) evaluations. | Non-Clinical: Preclinical Toxicology Tests |
| Compatibility/Cleaning Efficacy | Demonstrate product compatibility with soft contact lenses. | "The studies demonstrated the compatibility... of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen." | Non-Clinical: Compatibility Studies |
| Compatibility/Cleaning Efficacy | Demonstrate cleaning efficacy for laboratory deposited lenses. | "The studies demonstrated... cleaning efficacy of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen." | Non-Clinical: Cleaning Efficacy Studies |
| Clinical Safety & Efficacy | Clinically evaluate safety and efficacy of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen for cleaning, rinsing, and disinfection of all soft (hydrophilic) contact lenses. | "This clinical study demonstrated the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen is safe and effective for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses." | Clinical Study |
2. Sample Size Used for the Test Set and Data Provenance
-
Clinical Study Test Set:
- Sample Size: 65 patients / 130 eyes
- Data Provenance: Not explicitly stated, but clinical studies for FDA submissions typically involve prospective data collection within a controlled clinical trial setting, likely within the US given the submission to the FDA. The document does not specify if it was retrospective or prospective, but clinical trials are generally prospective.
-
Non-Clinical Studies (Microbiological, Preclinical, Compatibility/Cleaning Efficacy):
- Sample Size: Not specified in the provided text for these studies.
- Data Provenance: Not specified. These are laboratory-based studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the document. The clinical study evaluated safety and efficacy, which generally involves clinicians assessing outcomes, but the number and qualifications of experts for establishing 'ground truth' in the context of diagnostic performance are not applicable or detailed for this type of product (a contact lens cleaning solution).
4. Adjudication Method for the Test Set
- Not applicable/Not specified. For a contact lens cleaning solution, outcomes are typically measured through objective and subjective clinical assessments (e.g., irritation, protein removal, microbial counts) rather than a diagnostic 'ground truth' established by multiple expert readers requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for diagnostic devices where human readers interpret medical images or data. The OPTI-FREE® SUPRACLENS® is a contact lens cleaning solution, not a diagnostic device.
6. Standalone Performance Study
- Yes, a standalone study was performed in the context of microbiological effectiveness.
- The "Microbiological Studies" section states, "The formulation meets the Stand-Alone criteria for disinfection of contact lens against bacteria, yeast and mold." This refers to established regulatory guidelines for testing the disinfectant properties of contact lens solutions acting alone without human intervention in the disinfection process itself.
7. Type of Ground Truth Used
- Microbiological Studies: Ground truth was based on established FDA Guidelines for contact lens solutions, which define the "Stand-Alone criteria" for microbial reduction (bacteria, yeast, mold). This is a quantitative, laboratory-based standard.
- Preclinical Toxicology: Ground truth was based on scientific standards for cytotoxicity and ocular irritation, measured through laboratory tests (agar overlay, ocular irritation evaluations).
- Compatibility/Cleaning Efficacy: Ground truth was based on objective measures of compatibility with contact lens materials and the ability to remove laboratory-deposited substances.
- Clinical Study: Ground truth for safety and efficacy was established through clinical observation and assessment by eye care practitioners, likely involving a combination of objective clinical findings and potentially patient-reported outcomes (e.g., comfort).
8. Sample Size for the Training Set
- Not applicable/Not specified. This device is a cleaning solution, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning model development. The product development would involve formulations and testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is not an AI/machine learning device, so there is no training set or associated ground truth establishment in that context.
§ 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.”