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510(k) Data Aggregation
(43 days)
SOLO-CARE PLUS Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat)disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.
SOLO-Care Plus Multi-Purpose Solution is a sterile aqueous solution containing sodium chloride, bis-tris propane, pluronic F127. cremephor and preserved with edetate disodium dihydrate 0.025% and polyhexanide 0.0001%.
Here's a summary of the acceptance criteria and study information for the SOLO-Care Plus Multipurpose Solution, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Study/Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Silicone Hydrogel Lens Compatibility | Meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry, Premarket Notification 510(k) Guidance Document for Contact Lens Care products (specifically, no significant difference from saline control in optical and physical changes). | The study showed no significant difference between SOLO-Care™ Plus Multi-Purpose Solution and the saline control solution with respect to optical and physical changes in the measured properties of Lotrafilcon A (silicone hydrogel) lenses. The device meets the specified FDA guidelines. |
| In Vitro Cleaning Efficacy (Protein Removal) | Substantially equivalent to currently marketed SOLO-Care Multipurpose Solution. | SOLO-Care Plus was found to be substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal. |
| Cytotoxicity | Non-cytotoxic and non-irritant. | Testing demonstrated that SOLO-Care Multipurpose Solution (which SOLO-Care Plus is based on) is non-cytotoxic and a non-irritant. |
| Microbiological Efficacy (Disinfection) | Meets "stand-alone criteria with organic load for disinfection" for both rub/rinse and pre-rinse/no rub regimens. Regimen test criteria also met for both regimens. | Both the rub/rinse and pre-rinse/no rub regimens demonstrated that SOLO-Care Multipurpose Solution met the stand-alone criteria with organic load for disinfection. The regimen test criteria were also met for both regimens for SOLO-Care Plus. |
| Clinical Testing | To support substantial equivalency to a predicate device. | A series of clinical studies were conducted, submitted, and reviewed in the original 510(k) submission (K012731) to support the substantial equivalency of SOLO-Care Plus. The current submission concludes substantial equivalence based on this data. |
2. Sample Sizes Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample sizes used for the test sets in the various studies (Silicone Hydrogel Lens Compatibility, In Vitro Cleaning Efficacy, Cytotoxicity, Microbiological, Clinical Testing).
The data provenance is retrospective for most tests. The document repeatedly states, "This data was previously submitted and reviewed in original 510(k) submission - K012731," indicating that the results from previous studies on the predicate device (SOLO-Care Multipurpose Solution) or an earlier version of SOLO-Care Plus were used to support the current submission. The Silicone Hydrogel Lens Compatibility study, however, appears to be a new study specific to the current submission ("A study was conducted to verify that Lotrafilcon A (silicone hydrogel) lenses are compatible with SOLO-Care Plus.").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For an in vitro device like a contact lens solution, "ground truth" often refers to objective laboratory measurements (e.g., optical properties, protein levels, CFU counts, cell viability) rather than subjective expert assessment. Clinical "ground truth" would likely involve patient outcomes or assessments by eye care practitioners, but the specific details (number of experts, qualifications) are not given for the clinical studies mentioned.
4. Adjudication Method for the Test Set
This information is not provided in the document. As noted above, for laboratory-based tests, adjudication methods typical for image-based or diagnostic studies (like 2+1) are not usually applicable. For clinical studies, the document does not elaborate on how outcomes were assessed or discrepancies resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not mentioned or applicable in this context. The document pertains to a medical device (contact lens solution) and its performance through in vitro and clinical studies, not an AI diagnostic algorithm requiring human reader comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
No, a standalone algorithm study is not applicable here. This device is a chemical solution, not an algorithm. The performance described (compatibility, cleaning, cytotoxicity, disinfection) is the standalone performance of the solution itself.
7. The Type of Ground Truth Used
Based on the descriptions:
- Silicone Hydrogel Lens Compatibility: Objective physical and optical measurements of the lenses (e.g., as compared to a saline control).
- In Vitro Cleaning Efficacy: Measured protein removal levels.
- Cytotoxicity: Laboratory assays (e.g., cell viability, irritation scores) to determine non-cytotoxicity and non-irritancy.
- Microbiological Efficacy: Quantitative microbial counts (e.g., Colony Forming Units - CFU) to demonstrate disinfection efficacy against specific microorganisms, compared to established "stand-alone criteria."
- Clinical Testing: Not explicitly detailed, but would likely involve clinical endpoints related to lens wear comfort, ocular health, and adverse events as assessed by eye care practitioners or reported by patients, used to establish substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable or provided. This device is a chemical solution, not an AI algorithm that requires a "training set." The studies described involve testing the solution's properties, not training a model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as #8.
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