(84 days)
OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with clear and tinted, daily wear and extended wear soft (hydrophilic) contact lenses or rigid gas permeable (silicone acrylate fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE® Multi-Purpose Solution, or OPTI-FREE® EXPRESS Multi-Purpose Solution or conditioned in OPTI-SOAK" Conditioning Solution or Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392. Use as recommended by your eye care practitioner.
Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 is for the disinfection and conditioning after cleaning and rinsing of clear and tinted, daily and extended wear fluorosilicone acrylate and silicone acrylate rigid gas permeable lenses.
Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.
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.
Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 is a sterile, aqueous solution buffered to approximate the pH and tonicity of the eye. It contains METHOCEL", a wetting and cushioning agent, boric acid, sodium borate, sodium chloride and mannitol, and is preserved with POLYQUAD® (polyguaternium-1) 0.0011%, and edetate disodium 0.10%.
The provided text describes the regulatory filing for a contact lens cleaning and disinfecting solution, detailing its components, intended use, and substantial equivalence to existing products. It also mentions safety and effectiveness studies. However, the document does not contain the specific kind of performance metrics, acceptance criteria, study details, and ground truth information that would typically be found in a study proving a device meets acceptance criteria in the context of a medical device evaluation for diagnostic or AI-based devices.
The information provided pertains to contact lens solutions, which are regulated differently and typically require demonstration of antimicrobial efficacy, cleaning efficacy, and lens compatibility rather than diagnostic performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot extract the requested information using the provided text.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance in terms of diagnostic metrics.
- Sample sizes used for a "test set" or information about data provenance for such a test set.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance results.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set or how ground truth for a training set was established.
The "studies" mentioned are largely microbiological studies, preclinical cytotoxic evaluations, compatibility/cleaning efficacy evaluations, and a general clinical study stating safety and effectiveness for a contact lens solution regimen. These are not equivalent to a performance study for a diagnostic AI device.
If you can provide a document related to a diagnostic or AI-based device, I would be happy to help extract the information you are seeking.
§ 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.”