(43 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 (including silicone hydrogel lenses) as recommended by your eye care practitioner.
The 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. The solution is indicated for use in simultaneous cleaning and disinfecting, daily protein removal, and storing of soft (hvdrophilic) contact lenses as recommended by your eve care practitioner.
The provided text does not contain detailed acceptance criteria or a comprehensive study report in the format typically used for medical device performance. Instead, it is a 510(k) summary for a contact lens care solution, which refers to previously submitted studies and guidelines for demonstrating substantial equivalence.
However, based on the information provided, I can infer some aspects related to acceptance criteria and the nature of the studies.
1. Table of Acceptance Criteria and Reported Device Performance
The document implicitly refers to FDA guidance documents as the source of acceptance criteria. The specific performance metrics are mentioned in relation to meeting these guidelines.
| Category | Acceptance Criteria (Inferred from FDA Guidance) | Reported Device Performance |
|---|---|---|
| Silicone Hydrogel Lens Compatibility | Lenses should not show significant optical or physical changes when treated with the solution compared to a control (e.g., saline). (Based on FDA's May 1, 1997 Guidance for Industry) | "The study showed there was no significant difference between AOSEPT Clear Care Cleaning and Disinfecting Solution and the saline control solution, with respect to optical and physical changes in the measured properties of the lenses." |
| In Vitro Cleaning Efficacy (Daily Protein Removal) | The solution should demonstrate cleaning efficacy (specifically protein removal) that is substantially equivalent to a legally marketed predicate device. | "Results of the study showed that AOSEPT Clear Care is substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal." |
| Cytotoxicity | The solution must be non-cytotoxic and a non-irritant. | "Results of the testing demonstrated that AOSEPT Clear Care is non-cytotoxic and is a non-irritant." |
| Microbiological Efficacy | The solution must meet 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." | "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." |
| Clinical Safety/Equivalence | The solution should demonstrate substantial equivalence in clinical performance and safety compared to other currently marketed solutions. (Clinical studies support substantial equivalence). | "Data from the clinical studies supported the substantial equivalence of AOSEPT Clear Care." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the test sets in any of the mentioned studies (silicone hydrogel compatibility, cleaning efficacy, cytotoxicity, microbiology, clinical studies).
The data provenance is implied to be from studies conducted to support FDA submissions in the US, given the sender is a US company and referring to FDA guidance. Whether the data is retrospective or prospective is not explicitly stated, but clinical and compatibility studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies mentioned are primarily laboratory (in vitro) or clinical performance studies, not studies relying on expert consensus for "ground truth" in the way an AI diagnostic device would. For clinical studies, the "ground truth" would be established by clinical outcomes and observations, potentially by eye care practitioners, but their specific number and qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies where multiple human readers are interpreting data (e.g., medical images) and their discrepancies need to be resolved to establish an agreed-upon ground truth. The studies cited are for a contact lens cleaning solution and do not involve such a process.
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
This information is not applicable/provided. The product is a contact lens care solution, not an AI-powered diagnostic device. Therefore, MRMC studies evaluating human readers with and without AI assistance are not relevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A form of standalone testing was done for the microbiological efficacy. The summary states: "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." This "stand-alone criteria" implies an in vitro test of the solution's ability to kill microorganisms without human intervention.
For other tests (cleaning, cytotoxicity, compatibility), these are inherently "standalone" in the sense that they evaluate the properties and effects of the solution directly, not in conjunction with human interpretation in a diagnostic loop.
7. The Type of Ground Truth Used
- Silicone Hydrogel Lens Compatibility: Measured properties of the lenses (optical, physical changes) against a control (saline).
- In Vitro Cleaning Efficacy: Quantitative measurement of protein removal, compared to a predicate device.
- Cytotoxicity: In vitro assays to determine toxicity and irritant potential.
- Microbiology: Quantitative reduction of specific microorganisms in a controlled laboratory setting as per FDA guidance.
- Clinical Testing: Clinical observations and outcomes related to contact lens wear, comfort, and ocular health. The ground truth would be based on clinical assessments rather than a single "expert consensus" pathology or outcome data in the context of an AI device.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of a chemical solution. "Training set" is a term used for machine learning models, which this product is not. The studies conducted are traditional laboratory and clinical studies.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of device.
§ 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.”