(65 days)
SOLO-Care ™ Brand Multi-Purpose Solution Is Indicated for use in daily cleaning, ninsing, chemical (not haat) disinfecting, protein removal and storing of soft (hydrophilic) or rigld gas permeable (fluoro sillcone acrylate and sillcone acrylate) lenses as recommended by your eye care precitioner.
SOLO-Care™ Brand Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, polyoxyethylene polyoxypropylene block copolymer, sodium phosphate dibasic, sodium phosphate monobasic, and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%. SOLO-Care™ Brand Multi-Purpose Solution contains multiple active ingredients in sufficient concentration to perform the function of daily cleaning, protein removal, rinsing, disinfecting, and storing soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.
This document is a 510(k) Summary for the SOLO-Care™ Brand Multi-Purpose Solution, which is a contact lens solution. It describes the device's indications for use, its substantial equivalence to a predicate device, and outlines the studies conducted to demonstrate its safety and effectiveness.
Here's the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative or tabular format for specific performance metrics (e.g., microbial kill rates, protein removal percentages with thresholds). Instead, it states that various studies were conducted to confirm safety and effectiveness, and that the product is shown to be "substantially equivalent" to a predicate device.
However, we can infer the intent of the acceptance criteria based on the described functions and comparative claims. The performance is reported in terms of its ability to perform these functions effectively and its compatibility.
| Acceptance Criteria (Inferred from described functions and claims) | Reported Device Performance |
|---|---|
| Cleaning of soft (hydrophilic) and rigid gas permeable (RGP) contact lenses | SOLO-Care™ Brand Multi-Purpose Solution successfully performs daily cleaning. |
| Protein Removal for soft (hydrophilic) and RGP contact lenses | SOLO-Care™ Brand Multi-Purpose Solution successfully performs protein removal. (Also noted previous approval for daily protein removal for soft lenses under K982168). |
| Rinsing of soft (hydrophilic) and RGP contact lenses | SOLO-Care™ Brand Multi-Purpose Solution successfully performs rinsing. |
| Chemical Disinfection (not heat) of soft (hydrophilic) and RGP contact lenses | SOLO-Care™ Brand Multi-Purpose Solution successfully performs chemical disinfection. |
| Storing of soft (hydrophilic) and RGP contact lenses | SOLO-Care™ Brand Multi-Purpose Solution successfully performs storing. |
| Compatibility with rigid gas permeable (fluoro silicone acrylate and silicone acrylate) lenses under recommended care regimen | Lens solution compatibility tests indicated that SOLO-Care™ Brand Multi-Purpose Solution is compatible with RGP lenses, demonstrating equivalence to the predicate device (Boston Simplicity). |
| Compatibility with Focus Lens Drops | An additional compatibility study was successfully conducted to determine compatibility with Focus Lens Drops. |
| Safety and Effectiveness | A series of preclinical and clinical studies were conducted to assess and demonstrate the safety and effectiveness of SOLO-Care™ Brand Multi-Purpose Solution. |
| Substantial Equivalence to BOSTON Simplicity Multi-Action Solution | SOLO-Care™ Brand Multi-Purpose Solution is substantially equivalent for daily cleaning, rinsing, disinfecting RGP lenses. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "A series of preclinical and clinical studies have been conducted to assess and demonstrate the safety and effectiveness..." However, no specific sample sizes for clinical or preclinical test sets are provided within this document.
The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given it's an FDA submission, the studies would typically be prospective for clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The evaluation of contact lens solutions typically involves laboratory testing for microbial reduction, cytotoxicity, and clinical trials for safety and comfort, which are assessed by various medical professionals and technicians, but "experts" establishing ground truth in the sense of image interpretation is not directly applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation where there's subjectivity and disagreement among readers. This is not directly relevant to the testing of a contact lens solution.
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
No MRMC comparative effectiveness study was done, as this device is a contact lens solution, not an AI-powered diagnostic tool. Therefore, there is no effect size related to human readers improving with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done, as this device is a chemical solution, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a contact lens solution, "ground truth" generally refers to:
- Laboratory-based measurements: e.g., microbial kill rates using standardized organisms, protein removal efficacy, cleaning efficacy using simulated soiling, lens compatibility assessments.
- Clinical outcomes data: e.g., slit lamp examinations for ocular health, patient reported comfort, adverse event rates, visual acuity.
- Comparison to predicate device performance benchmarks.
The document generically states "preclinical and clinical studies have been conducted to assess and demonstrate the safety and effectiveness." It implies that standard test methods applicable to contact lens solutions were used to establish the "ground truth" for these various performance parameters.
8. The sample size for the training set
This information is not provided and is not applicable in the context of a chemical contact lens solution. "Training set" refers to data used to train machine learning models, which are not involved in this device's development or evaluation.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons stated in point 8.
§ 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.”