(136 days)
AOSept Clear Care Cleaning and Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.
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.
Here's a breakdown of the acceptance criteria and study information for the AOSEPT Clear Care Cleaning and Disinfecting Solution, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Device Performance (AOSept Clear Care) |
|---|---|---|
| Compatibility | Optical Parameters (Paraperm EW RGP Lenses - Power, Base Curve, Diameter) | Maintained within specifications after 30 cycles |
| Physical Parameters (Paraperm EW RGP Lenses - Visual appearance, % transmittance, microscope) | Maintained within specifications after 30 cycles | |
| Optical Parameters (Fluoroperm 30 RGP Lenses - Power, Base Curve, Diameter) | Maintained within specifications after 30 cycles | |
| Physical Parameters (Fluoroperm 30 RGP Lenses - Visual appearance, % transmittance, microscope) | Maintained within specifications after 30 cycles | |
| Compatibility with Focus Lens Drops (lubricating/rewetting) | Successfully demonstrated compatibility | |
| Compatibility with Aquify Lens Drops (lubricating/rewetting) | Successfully demonstrated compatibility | |
| Microbiology | ISO 14729 (FDA 510(k)) Stand Alone Test | Provides effective disinfection based on criteria |
| ISO 14729 (FDA 510(k)) Regimen Test | Provides effective disinfection based on criteria | |
| Biocompatibility | FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance for Contact Lens Care Products | Meets guidelines; non-toxic and biocompatible (from previous studies) |
| Clinical Effectiveness (RGP Lenses) | Lenses "clean" after 1-month wear | 91% reported none or slightly deposited |
| Subject reporting lens needs cleaning at follow-up 2 | 7% reported lenses needed cleaning | |
| Usage of lubricating drops prior to insertion every day | 29% of AOSept Clear Care users | |
| Comfort grading (0-10 scale) at Follow-up 2 | Reported high ( > 8.5) | |
| (Comparative with Aquify vs. Focus Clerz) | Aquify users showed higher comfort, fewer lens deposits, better wettability |
2. Sample Sizes and Data Provenance
- Test Set (Clinical Study for RGP Lenses): The text states, "Two thirds of subjects used the AOSept Clear Care, while and one-third used the control solution." The total number of subjects is not specified, only the ratio.
- Data Provenance: The RGP lens clinical study was a "one-month prospective randomized trial." The country of origin of the data is not explicitly stated, but the submission is from CIBA Vision Corporation in Duluth, Georgia, USA, suggesting the study was likely conducted in the USA.
- Other Studies (Compatibility, Microbiology, Biocompatibility): Sample sizes for these preclinical studies are not provided in this summary. The summary mentions these were "previously conducted" and "reviewed by FDA under two 510(k), K013512 and K003345."
3. Number of Experts and Qualifications for Ground Truth
This submission does not detail the use of experts to establish ground truth in the typical sense of a diagnostic medical device's performance claims.
- For the clinical study, a "one-month prospective randomized, trial" was conducted. The "ground truth" for clinical effectiveness (e.g., lens cleanliness, comfort) would be based on subject reporting and potentially investigator observations. The qualifications of the clinical investigators are not specified.
- For pre-clinical tests (Microbiology, Compatibility, Biocompatibility), the "ground truth" is defined by standardized test methods (e.g., ISO 14729) and regulatory guidelines (e.g., FDA guidance documents, GLP regulations). Performance against these standards serves as the benchmark, rather than expert consensus on individual cases.
4. Adjudication Method
- No specific adjudication method (like 2+1 or 3+1) is mentioned or appears applicable given the nature of the device (contact lens solution) and the types of studies performed (compatibility, microbiology, clinical trial for lens care). Clinical endpoints like "lens cleanliness" and "comfort" are typically assessed by the subject or clinical investigator, not through a multi-expert adjudication of a diagnostic finding.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance. This device is a contact lens care solution, and its evaluation methodologies do not involve MRMC studies.
6. Standalone (Algorithm Only) Performance Study
- Not applicable/done in the context of an algorithm. This product is a chemical solution. The "standalone performance" is demonstrated by the various in vitro and in vivo tests, such as the ISO 14729 Stand Alone Test and Regimen Test for antimicrobial activity, which evaluate the solution's properties independent of human interaction during the test itself, but these tests are not for an AI algorithm.
7. Type of Ground Truth Used
- Compatibility: Ground truth is established by objective measurements against pre-defined specifications (e.g., optical power, diameter, visual appearance, % transmittance) and compliance with regulatory guidelines.
- Microbiology: Ground truth is established by adherence to in vitro antimicrobial efficacy standards as defined by ISO 14729 and FDA 510(k) performance criteria for contact lens disinfecting solutions, measured by reductions in microbial populations.
- Biocompatibility: Ground truth is established by meeting the guidelines set forth in FDA guidance documents and demonstrating non-toxicity and biocompatibility through standard tests.
- Clinical: Ground truth for effectiveness with RGP lenses is based on observed clinical outcomes and subject-reported data (e.g., lens cleanliness scores, comfort ratings, need for rewetting drops).
8. Sample Size for the Training Set
- Not applicable. This product is a chemical solution, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI/ML algorithm, there is no training set or associated ground truth establishment process.
§ 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.”