(202 days)
COMPLETE® BLINK-N-CLEAN® Lens Drops is indicated to lubricate and rewet soft (hydrophilic) contact lenses, disposable lenses and extended wear lenses, as well as rigid gas permeable lenses before application and during wear.
COMPLETE® BLINK-N-CLEAN® Lens Drops is a sterile, isotonic, buffered, solution containing lubricants, preservatives, buffers, surfactants, ancillary ingredients, and purified water. The product is a clear, colorless solution packaged in plastic bottles with controlled dropper tips.
The provided text describes a 510(k) summary for COMPLETE® BLINK-N-CLEAN® Lens Drops, which is a medical device. However, the information available in the document is primarily related to its regulatory submission and non-clinical testing for compatibility and protein removal, not advanced AI/ML device studies as implied by the detailed questions about acceptance criteria, ground truth, expert adjudication, and MRMC studies.
Therefore, many of the requested details cannot be extracted or are not applicable to the type of device and study described.
Here's an attempt to answer based on the provided text, highlighting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compatibility with Lenses: | |
| Average changes in diameter (silicone acrylate and fluorosilicone acrylate RGP) | Within established acceptance criteria, comparable to controls. |
| Average changes in power (silicone acrylate and fluorosilicone acrylate RGP) | Within established acceptance criteria, comparable to controls. |
| Average changes in base curve (silicone acrylate and fluorosilicone acrylate RGP) | Within established acceptance criteria, comparable to controls. |
| Absence of surface deposits, discoloration, and/or deformities. | No evidence observed. |
| Protein Removal: | |
| Significant protein removal compared to predicate devices. | Significant amount of protein removed compared to predicate devices. |
| Preclinical Safety and Efficacy: | Established in P910075/S7. |
| Clinical Safety and Acceptability: | Established in 910075/S7. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Compatibility Test: Thirty (30) regimen cycles of silicone acrylate and fluorosilicone acrylate rigid gas permeable (RGP) lenses.
- Data Provenance: Not specified in terms of country of origin or whether it was retrospective/prospective for the compatibility and protein removal studies. It appears to be non-clinical laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the reported studies are non-clinical (compatibility and protein removal) and do not involve expert interpretation or ground truth establishment in the context of clinical expert consensus. The "ground truth" here is objective physical measurements and chemical analysis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable to the non-clinical studies described.
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 device is a lens care solution, not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a lens care solution, not an algorithm. The reported studies evaluate the physical and chemical performance of the solution itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Compatibility: Objective physical measurements (diameter, power, base curve) and visual observations (surface deposits, discoloration, deformities) of contact lenses after exposure to the product.
- For Protein Removal: Quantitative analytical methods measuring protein accumulation and removal from human-worn contact lenses in a simulated in-eye use.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”