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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

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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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.

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.

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