(98 days)
AOSEPT Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses as recommonded by your eye care practitioner.
The AOSept Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant.
The provided text is a 510(k) summary for a contact lens care product, not a medical device that utilizes AI or algorithmic performance for diagnostics or treatment. Therefore, the information requested in your prompt regarding acceptance criteria, study design, expert involvement, and AI-specific metrics (like MRMC studies or standalone algorithm performance) is not applicable to this document.
The document discusses the substantial equivalence of AOSEPT Clear Care Cleaning and Disinfecting Solution to a predicate device based on pre-clinical and clinical studies submitted previously (K003345 and K013512). It confirms its intended use for cleaning, disinfecting, daily protein removal, and storing soft contact lenses.
Without details from the referenced prior submissions (K003345 and K013512), it's impossible to extract specific acceptance criteria, reported performance, or study methodologies that traditionally apply to AI-driven medical devices.
Summary of inapplicable questions:
- 1. A table of acceptance criteria and the reported device performance: Not provided. This document describes a chemical solution, not a performance-based diagnostic device.
- 2. Sample sized used for the test set and the data provenance: Not provided. The studies mentioned (K003345, K013512) are for the chemical solution's safety and effectiveness.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would relate to microbiological efficacy or clinical outcomes, not expert image interpretation.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted device.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated, but would likely involve microbiological challenge tests and clinical trial outcomes for safety/efficacy in contact lens care.
- 8. The sample size for the training set: Not applicable. There is no "training set" for this type of product.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.”