(311 days)
Use LENS PLUS® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use LENS PLUS® Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.
Lens Plus® Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution containing sodium chloride and boric acid. The product is packaged in a plastic sterile reclosable vial which allows remaining drops can be used throughout the day (12 hours).
The provided text describes a 510(k) summary for "Lens Plus® Rewetting Drops" and its substantial equivalence to a predicate device. This document focuses on the safety and performance of a medical device (rewetting drops) and not on the performance of an AI/ML algorithm.
Therefore, the requested information categories concerning AI/ML algorithm performance (such as sample sizes for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, and training set details) are not applicable to this document. The study described is a non-clinical bacteriostasis study.
Here's the relevant information that can be extracted from the provided text, structured to address the spirit of your request:
Acceptance Criteria and Device Performance Study for Lens Plus® Rewetting Drops (K042562)
The primary "acceptance criterion" for this device, as detailed in the 510(k) summary, revolves around demonstrating the ability of bacteria to not significantly grow and survive in the reclosable vials containing the rewetting drops over a designed period, specifically to support a 12-hour discard statement.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| No significant growth and survival of specified bacteria over time | Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger showed no significant growth and survive over the designed period. |
| Support for 12-hour discard statement | "The data support the desired discard statement on label of up to 12 hours." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not explicitly stated in terms of number of vials or bacterial cultures beyond the types of bacteria tested. The study mentions testing against five specific microorganisms.
- Data Provenance: The study was conducted "in accordance with Micro Appendix C of the Premarket Notification (510(K)) Guidance Document for contact Lens Care Products." This is a non-clinical, controlled laboratory study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a laboratory study evaluating bacteriostasis, not requiring human expert interpretation in the way AI/ML ground truth is established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a laboratory study.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" here is the objective microbial growth/survival data obtained from the bacteriostasis study, evaluated against established microbiological standards for such products.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and no training set was used.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.”