(59 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 recommended by your eye care practitioner.
The AOSept Clear Care Cleanir, 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 solution is indicated for use in simultaneous cleaning and disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses as recommended by your eve care practitioner.
Here's an analysis of the provided text regarding the AOSEPT Clear Care Cleaning and Disinfecting Solution, focusing on acceptance criteria and supporting studies:
This document primarily describes the substantial equivalence of a contact lens cleaning solution to existing products, rather than a medical device employing AI or complex algorithms. Therefore, many of the standard questions regarding AI device evaluation (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not directly applicable.
However, I can extract the relevant information from the provided text in the requested format where possible, and indicate when information is not applicable or not provided for this type of product.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Measurement | Predicate Device (Control) Performance | AOSEPT Clear Care Performance (Results) | Met Criteria? |
|---|---|---|---|---|
| Microbiology | Stand-alone disinfection efficacy | Not specified (implied by predicate) | Meets FDA 5/1/1997 Guidance criteria | Yes |
| Cleaning (Protein Removal) | Daily protein removal | ReNu Multiplus, OptiFree Express | Substantially equivalent | Yes |
| Clinical Performance (Subjective) | Insertion comfort (preference) | Bausch & Lomb ReNu Multi-Plus | Statistically significant improvement | Yes |
| Overall dryness (preference) | Bausch & Lomb ReNu Multi-Plus | Statistically significant improvement | Yes | |
| Lens cleanliness (preference) | Bausch & Lomb ReNu Multi-Plus | Statistically significant improvement | Yes | |
| All subjective ratings | Bausch & Lomb ReNu Multi-Plus | Statistically significant improvement | Yes | |
| All subjective preference rankings | Bausch & Lomb ReNu Multi-Plus | Statistically significant improvement | Yes | |
| Clinical Performance (Objective) | Front surface wetting (investigator observation) | Bausch & Lomb ReNu Multi-Plus | Similar | Yes |
| Lens deposits (investigator appraisal) | Bausch & Lomb ReNu Multi-Plus | No statistically significant difference | Yes | |
| Objective dark-field image analysis (90 days) | Bausch & Lomb ReNu Multi-Plus | No statistically significant difference; clinically acceptable cleanliness | Yes | |
| Safety | Clinical acceptability (no-rub regimen for >1 month worn lenses) | Bausch & Lomb ReNu Multi-Plus (rub regimen) | Clinically acceptable and similar | Yes |
2. Sample size used for the test set and the data provenance:
- Sample Size (Clinical Evaluation): Not explicitly stated as a number of participants. It mentions "Study participants were all randomized."
- Data Provenance: Prospective, randomized, single masked, contralateral trial. No country of origin is explicitly stated, but the submitter information is from Duluth, Georgia, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device (contact lens solution). The "ground truth" for clinical efficacy and safety was established through participant feedback, investigator observations, and objective measurements (dark-field image analysis). "Investigators" observed front surface wetting and appraised lens deposits, but their number and specific qualifications (e.g., ophthalmologist, optometrist) are not detailed.
4. Adjudication method for the test set:
- Not applicable as this is not an image-based or diagnostic device requiring expert adjudication. The study used a "single masked" design, where participants were masked to which eye received the test vs. control product.
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 diagnostic device. The study compared two contact lens care solutions.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device. The "standalone" term is used in the context of microbiology testing, referring to the solution's ability to disinfect by itself, without a separate cleaning step. The text notes: "These studies demonstrate that AOSEPT Clear Care meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products."
7. The type of ground truth used:
- Performance (Microbiology): Compliance with FDA guidance for disinfection efficacy.
- Performance (Cleaning): Objectively measured protein removal, and dark-field image analysis of lenses for cleanliness.
- Clinical Efficacy/Safety: Subjective feedback (insertion comfort, dryness, cleanliness, overall preference) from study participants and objective observations/appraisals by investigators.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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.”