(156 days)
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (active ingredient, sodium hypochlorite) and Progent B (active ingredient, potassium bromide). Progent A and B are mixed in a Menicon SP Vial. Allow lenses to soak in the Progent solution mixture for 30 minutes. Soaking for longer than 30 minutes is not recommended. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eye care professional's directions (to a maximum of every 5 days).
The provided 510(k) summary for K122273 describes the Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses. This submission focuses on the equivalence of an alternative rinsing solution (sterile normal saline) to a previously cleared one (sterile purified water) and an alternative manufacturing site. Therefore, the study described is a non-clinical equivalence study rather than a study typically seen for novel diagnostic devices.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Rinsing effectiveness of sterile normal saline (based on active chlorine concentrations and pH values) is equivalent to sterile purified water. | "A comparison of the two sets of data was completed and based on active chlorine concentrations and pH values it was confirmed that the rinsing efficacy of sterile normal saline was equal to the rinsing efficacy of the sterile purified water." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of lenses or test runs) used for the "Residual Progent Testing." It only mentions that the test was "repeated with sterile normal saline."
- Data Provenance: The study was conducted by Menicon Co., Ltd. (Japan) as part of their 510(k) application. It is a non-clinical, bench-top study rather than a study involving human subjects or real-world data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve human experts establishing ground truth in the traditional sense of medical image analysis or diagnostic studies. The "ground truth" here is objective chemical measurement in vitro.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical, objective measurement study, not one requiring adjudication by human observers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This was a non-clinical bench study comparing rinsing efficacy of two solutions, not a study involving human readers or comparative effectiveness in a clinical setting.
6. If a Standalone Performance Study Was Done
Yes, in a sense. The "Residual Progent Testing" was done to evaluate the performance of the rinsing solutions in a controlled environment, independently measuring residual active chlorine concentration and pH. However, it's not a "standalone algorithm performance" in the context of AI/diagnostic devices, but rather a standalone test of a specific device function. The purpose was to show equivalence to a previously cleared product, so the performance was evaluated relative to the predicate.
7. The Type of Ground Truth Used
The ground truth was established by objective chemical measurements of active chlorine concentration and pH values in the rinsing solutions. This is an in vitro measurement, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is a non-clinical, bench-top study comparing two rinsing solutions. There is no machine learning component and therefore no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied.
§ 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.”