(44 days)
SOLO-Care ™ Hard Solution is indicated for use in daily cleaning, rinsing, chemical (not heat) disinfecting and conditioning of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses as recommended by your eye care practitioner.
SOLO-Care ™ HARD Solution is a sterile aqueous solution containing hydroxyethylicellulose, tris amino, sodium chloride, disodium edetate, poloxamer 407, polyoxyethylene polyoxpropylene block copolymer, and is preserved polyhexanide 0.0002%. SOLO-Care ™ HARD Solution contains multiple active ingredients in sufficient concentration to perform the function of daily cleaning, ninsing, disinfecting and conditioning rigid gas permeable and hard contact lenses as recommended by an eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.
The provided 510(k) summary for SOLO-Care™ HARD Solution outlines various acceptance criteria and the studies conducted to demonstrate substantial equivalence to predicate devices. However, the document primarily focuses on preclinical and clinical studies for safety and effectiveness rather than providing explicit numeric acceptance criteria for each test or detailed performance metrics. It also heavily relies on the concept of "substantial equivalence" rather than specific numerical performance targets.
Here's an attempt to extract the requested information based on the provided text, with notable limitations due to the nature of the document:
Acceptance Criteria and Study Findings for SOLO-Care™ HARD Solution
Overall Goal: To demonstrate substantial equivalence to predicate devices (BOSTON Advanced Conditioning Solution, BOSTON Classic, and Boston Simplicity Solution) in terms of usage, formulation similarities, and indications for use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Preclinical Testing | ||
| Cleaning Effectiveness | Sufficient surfactant concentration to maintain activity for cleaning and detergency. | "Results demonstrated that the surfactant concentration is formulated in SOLOCare Hard Solution at sufficiently high levels to maintain its activity for cleaning and detergency." |
| Contact Wetting Angle | Statistically equivalent surface wettability to predicate solution Boston Simplicity. | "Dynamic contact angle analysis indicated that the SOLO-care Hard Solution is statistically equivalent to predicate solution Boston Simplicity in terms of surface wettability of the lens." |
| Solution Compatibility | Lens parameters remain within ANSI/ISO reference range after 30 cycles; no change in cosmetic appearance. | "The study showed that after 30 cycles all parameters were still within the ANSI/ISO reference range for rigid gas permeable lenses for both solutions. In addition, there was no change in the cosmetic appearance of the lenses." |
| Stability (Chemical) | pH, osmolarity, viscosity, appearance, and active ingredients maintained for 24 months. | "Based on the data collected, the trends observed and the estimated calculations of the accelerated test samples the shelf life for SOLO-care HARD Solution is 24 months." |
| Stability (Microbiological) | Meet ISO/DIS 14730 Preservative Effectiveness Test requirements. | "The results demonstrate that SOLO-Care Hard meets the requirements of the ISO/DIS 14730 Preservative Effectiveness Test against the panel organisms tested." |
| Disinfection Efficacy | Meet ISO/CD 14729 requirements for antimicrobial effectiveness. | "The results demonstrated that the solution meets the requirements of the standard." |
| Toxicology | No toxic response or increase in ocular irritation. | "Results demonstrated that the solution and lenses treated with the solution did not cause a toxic response or increase ocular irritation." |
| Clinical Testing | ||
| Safety and Effectiveness | Non-inferiority/substantial equivalence to control solutions; no additional safety concerns. | "Analysis of all data from the studies showed no that the test and control solutions were substantially equivalent. In additional safety concerns were raised regarding the test solution." (Note: "no" likely a typo, intended as "no additional safety concerns were raised...") |
| Substantial Equivalence | Substantially equivalent in usage, formulation, and indications to predicate devices. | "SOLO-Care Hard Solution is substantially equivalent. to BOSTON Advanced Conditioning Solution, BOSTON Classic and Boston Simplicity Solution in terms of usage, formulation similarities, and indications for use..." |
Note on "Acceptance Criteria": The document uses terms like "sufficiently high levels," "statistically equivalent," "within the ANSI/ISO reference range," "meets the requirements of the standard," and "no toxic response." These are qualitative or referential criteria rather than specific numerical thresholds presented within the text itself. The specific numerical targets for ISO standards, ANSI/ISO ranges, or statistical equivalence thresholds are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Test Set Sample Size: "Overall 166 contact lens wearers were enrolled"
- Data Provenance: Not explicitly stated regarding country of origin. The studies were described as "preclinical and clinical studies." Given it's a 510(k) submission to the FDA, it's highly probable the clinical studies were conducted in the USA, but this is an inference. The studies appear to be prospective clinical trials involving contact lens wearers being exposed to the test and control solutions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The clinical studies simply state that "166 contact lens wearers were enrolled" and data was analyzed, but there's no mention of experts establishing a "ground truth" in the diagnostic sense (e.g., for a medical image or condition). The "ground truth" for a contact lens solution's safety and effectiveness would come from the observed clinical outcomes (comfort, ocular health, infection rates, etc.) of the enrolled subjects.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. Since this is a clinical trial assessing a contact lens solution, it typically involves clinical observations, subject questionnaires, and potentially eye care practitioner assessments, rather than a diagnostic adjudication process for a specific finding.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is typically relevant for diagnostic imaging devices where different readers interpret the same cases, often with and without AI assistance. This document describes preclinical and clinical studies for a contact lens solution, which does not fit the MRMC study design. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a contact lens solution, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this submission. The preclinical tests can be considered "standalone" in the sense that they assess the product's intrinsic physical, chemical, and microbiological properties.
7. The Type of Ground Truth Used
For the clinical studies, the "ground truth" was established by observed clinical outcomes and the absence of adverse events or additional safety concerns in human subjects using the solution over periods ranging from 1 to 6 months. This would include parameters like ocular health, comfort, clarity of vision, and any signs of infection or irritation, as assessed by eye care practitioners and reported by subjects. For preclinical studies, ground truth was based on established ISO standards, ANSI/ISO reference ranges, and laboratory test methodologies.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning algorithms. Since SOLO-Care™ HARD Solution is a physical product (a contact lens solution) and not an AI/ML diagnostic algorithm, there is no training set in that context. The "training" for the product development would involve chemical formulation and process optimization, not data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/ML device, this question is not applicable. The development process would have involved iterative formulation, testing against performance requirements (as outlined in the preclinical section), and refinement based on these results.
§ 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.”