(151 days)
SOLO-Care ™ Brand Multi-Purpose Solution is indicated for use In dally cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
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, daily 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.
Here's a breakdown of the acceptance criteria and the study details for the SOLO-CARE™ Brand MULTI-PURPOSE SOLUTION, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Goal | SOLO-CARE™ Device Performance/Outcome |
|---|---|---|
| Safety | Non-toxic | Results demonstrated non-toxicity |
| Biocompatible | Results demonstrated biocompatibility | |
| No safety issues with use without rinse prior to insertion | No safety issues raised with SOLO-Care™ Multi-Purpose Solution used without a rinse prior to insertion. | |
| Effectiveness (General) | Safe and effective as a multi-purpose soft (hydrophilic) contact lens solution | Results demonstrated the solution is safe and effective as a multi-purpose soft (hydrophilic) contact lens solution. |
| Effectiveness (Specific - Protein Removal) | Substantially equivalent to predicate device (ReNu® Multi-Purpose Solution / ReNu® 1 Step™ Enzymatic Cleaner) for removal of visible protein | Clinical results provide valid scientific evidence that SOLO-care™ Multi-Purpose Solution is substantially equivalent to ReNu® Multi-Purpose Solution / ReNu® 1 Step™ Enzymatic Cleaner for the removal of visible protein. |
| Substantial Equivalence | Comparable to other currently marketed soft contact lens solutions | Results demonstrate the solution is comparable to other currently marketed soft contact lens solutions. |
| Substantially equivalent to predicate device across all indicated uses (daily cleaning, protein removal, rinsing, disinfecting, storing) | SOLO-Care Brand Multi-Purpose Solution is substantially equivalent to Bausch & Lomb ReNu Multi-Purpose Solution used with Bausch & Lomb ReNu 1 Step Enzymatic Cleaner in that both are indicated for use in daily cleaning, daily protein removal, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document describes "A one month clinical evaluation" and "a series of preclinical tests." However, it does not specify the exact number of participants or samples used in either the preclinical or clinical studies.
- Data Provenance: The document does not explicitly state the country of origin for the data. The submitter is located in Duluth, Georgia, USA, and the FDA review is from the USA, suggesting the studies likely occurred in the USA. The studies were conducted adhering to "current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812)" for clinical studies and "GLP regulation (21 CFR Part 58)" for preclinical studies, which are US regulations. The studies appear to be prospective as they were conducted to assess the product's safety and effectiveness.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish a ground truth for the test set. For a clinical evaluation of a contact lens solution, ground truth would typically be established through patient self-assessment, clinical examinations by ophthalmologists or optometrists, and potentially laboratory analysis of lens deposits. However, these details are not provided in the given text.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
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 study was done. This is a medical device (contact lens solution), not an AI-powered diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance was done. This device is a solution, not an algorithm. Performance tests focused on the solution's properties and its effect on contact lenses and users.
7. The Type of Ground Truth Used
Based on the description:
- For safety, ground truth would be based on clinical observation of adverse events and preclinical toxicology/biocompatibility testing standards.
- For effectiveness (protein removal), ground truth was implicitly established by comparing the SOLO-Care™ solution's performance for "removal of visible protein" against the performance of the predicate device (ReNu® Multi-Purpose Solution / ReNu® 1 Step™ Enzymatic Cleaner). This suggests a comparative clinical outcome, likely visual assessment of protein deposits on lenses or other relevant clinical endpoints that demonstrate "removal of visible protein." The specific methodology for assessing "visible protein" is not detailed.
8. The Sample Size for the Training Set
The document does not refer to a training set in the context of an algorithm or AI. The term "training set" is not applicable to the development and testing of this type of medical device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the context of this device, this question is not applicable.
§ 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.”