(133 days)
SOLO-Care™ Plus Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic), rigid gas permeable (fluoro silicon acrylate and silicon acrylate) contact lenses as recommended by your eye care practitioner.
SOLO-Care Plus Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, SOLO-Gare Plus Mulli Purpood Solution and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%.
Here's a breakdown of the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of SOLO-Care Plus Multipurpose Solution, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define numerical "acceptance criteria" in the way one might see for diagnostic accuracy. Instead, the acceptance criteria are implicitly framed as "substantial equivalence" to predicate devices, meaning the new device performs at least as well or doesn't show significant negative differences across various safety and efficacy measures.
| Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Lens Compatibility | No significant difference in physical/optical properties compared to predicate devices. | "No significant difference between SOLO-Care™ Plus Multi-Purpose Solution and the predicate device... no significant optical and physical changes in the measured properties of the lenses." |
| Safe, biocompatible, and comparable to other marketed solutions. | "Results was conduction in accordance with and in conformance to applicable device regulations. Results demonstrated that SOLO-Care Plus is safe and biocompatible, and is comparable to other currently marketed soft contact lens solutions." | |
| Cleaning Efficacy | Substantially equivalent protein cleaning efficacy to predicate device. | "SOLOCare Plus is substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal." |
| Cytotoxicity | Non-cytotoxic and non-irritant. | "SOLO-Care Multipurpose Solution is non-cytotoxic and is a non-irritant." |
| Microbiological | Meet regiment test criteria for microbial efficacy under rub/rinse and pre-rinse regimens. | "Both regimen demonstrated that SOLO-Care Multipurpose [sic] no rub regimen. The no [sic] also disinfection. Additionally, the regiment test criteria was also meet for both regimen for SOLO-Care Plus." (Suggests criteria were met for both rub/rinse and pre-rinse protocols based on substantial equivalence.) |
| Clinical Safety/Comfort (Study #1) | Acceptable for proceeding to validation study; low safety variables; high comfort; low acceptable subjective complaints; substantially equivalent to predicate. | "SOLO-Care Plus was found to be an effective multipurpose solution... safety variables were low with little difference between the test solution and the control. Comfort levels were high at all times, and the subjective complaints were low in number and acceptable... substantially equivalent to SOLO-Care Multipurpose Solution." |
| Clinical Safety/Effectiveness (Study #2) | Safe and effective; substantially equivalent to predicate. | "SOLO-Care Plus was found safe and effective multipurpose solution for soft contact lenses and was found to be substantially equivalent to SOLOCare Multipurpose Solution." |
| Clinical Non-inferiority (Study #3) | Non-inferior to predicate using a no-rub regimen. | "The data in this clinical trial was consistent in showing substantial equivalence between SOLO-Care Plus without a rub and rinse versus Comfortplus Multipurpose Solution with a pre and post rinse with overnight soaking." |
2. Sample Sizes and Data Provenance
In-Vitro/Preclinical Studies:
- Lens Compatibility Data: Not specified.
- In Vitro Cleaning Efficacy: Not specified.
- Cytotoxicity: Not specified.
- Microbiological Studies: Not specified.
- Data Provenance: Implied to be from CIBA Vision Corporation's internal testing facilities (likely US-based) and conducted to applicable device regulations. Retrospective or prospective nature not explicitly stated, but typically these in-vitro tests are prospective.
Clinical Studies:
- Study #1: 15 subjects. Prospective, randomized, investigator masked, contralateral study. Likely conducted in the US based on the submitting company's location and FDA submission.
- Study #2: 95 subjects. Prospective, investigator masked, contralateral study. Likely conducted in the US.
- Study #3: 73 subjects. Prospective, randomized, investigator masked, contralateral study. Conducted in the UK ("BTP Crème versus Complete U.K. Clinical Trial").
3. Number and Qualifications of Experts for Ground Truth
For preclinical (in-vitro) studies, the "ground truth" is typically established through laboratory methodologies and internal quality control, not external expert consensus as would be seen for imaging diagnostics. The report doesn't specify an "expert" panel for these.
For clinical studies, the "ground truth" is generally patient-reported outcomes (comfort, subjective complaints) and investigator-assessed safety variables (e.g., ocular health parameters).
- Number of experts: Not explicitly stated as a separate ground-truth panel. However, the studies involved "investigators" who performed assessments.
- Qualifications of experts: Not specified beyond being "investigator masked." Given the nature of contact lens studies, these would typically be ophthalmologists, optometrists, or trained clinical researchers. Study #2 mentions "five investigator," implying five clinical sites or primary investigators.
4. Adjudication Method for the Test Set
- Preclinical (in-vitro) studies: Not applicable in the sense of expert adjudication. Results are based on direct measurement and established laboratory protocols.
- Clinical studies: The studies were "investigator masked" and "contralateral," meaning subjects used both the test and control solutions, and the investigator was unaware which eye received which solution until unmasking. This design intrinsically reduces bias. There is no mention of an independent adjudication committee for clinical endpoints beyond the assessing investigators themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where multiple readers interpret cases to assess accuracy in comparison to a gold standard. The device here is a contact lens solution, and the studies focused on safety, comfort, and efficacy (cleaning, disinfection) rather than diagnostic interpretation. Therefore, measurements like "effect size of how much human readers improve with AI vs without AI assistance" are not relevant to this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a contact lens solution, not an AI algorithm. The performance of the solution is assessed directly, sometimes with human "in-the-loop" performance in terms of patient use and investigator assessment (clinical studies), but not in the context of an algorithm's standalone performance.
7. Type of Ground Truth Used
- Preclinical (in-vitro) ground truth:
- Lens Compatibility: Laboratory measurements of physical and optical lens properties.
- In Vitro Cleaning Efficacy: Quantification of protein removal (laboratory assay).
- Cytotoxicity: Standardized cell culture assays for toxicity and irritation.
- Microbiological: Standardized microbiological challenge tests and culture methods to assess disinfection efficacy.
- Clinical (in-vivo) ground truth:
- Patient-reported outcomes: Subjective complaints, comfort levels.
- Investigator assessments: Ocular safety variables, clinical observations related to eye health and contact lens wear.
- Comparison to predicate device: The ground truth for proving substantial equivalence often relies on demonstrating non-inferiority or similar performance to an already accepted predicate device.
8. Sample Size for the Training Set
Not applicable. This device is a chemical solution, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The term "training set" is not relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical 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.”