(184 days)
The Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection, removal of proteins and storage of soft (hydrophilic) contact lenses, as recommended by the eye care practitioner
Sauflon Multipurpose Solution is a sterile, isotonic solution that contains poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorohexidine or thimerosal. Sauflon Multipurpose Solution remains unchanged from the previously approved product in K974485, except for the revised directions for use.
Here's a breakdown of the acceptance criteria and study information for the Sauflon Multipurpose Solution, based on the provided text:
Important Note: The provided document is a 510(k) summary for a multipurpose solution, which is a chemical product, not a medical device in the typical sense of AI-powered diagnostic or therapeutic tools. Therefore, many of the requested categories (like "Number of experts," "MRMC study," "AI assistance," "Standalone performance," "Training set sample size," etc.) are not applicable to this type of submission. The information provided focuses on the safety and efficacy of the solution itself and its comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance (Summary from Text) |
|---|---|---|
| Solution Compatibility | Compatibility with contact lenses. | "Details... contained in K974485." (Not explicitly stated in K030278, but referenced as already met). |
| Toxicology | Non-toxic for ophthalmic use. | "Toxicological testing... contained in K974485." (Not explicitly stated in K030278, but referenced as already met). |
| Container Material | Meet USP for ophthalmic containers. | "Sauflon Multipurpose solution container components meet the requirements of the USP... confirmed by... cytotoxicity, occular irritancy, and systemic toxicity tests." |
| Sterility | Sterile. | "Meets the requirements of sterility testing as per K974485." (Not explicitly stated in K030278, but referenced as already met). |
| Preservative Efficacy | Effective at preserving the solution. | "Meets the requirements of the preservative efficacy test with rechallenge at 14 days as per K974485."(Not explicitly stated in K030278, but referenced as already met). |
| Disinfection Efficacy | Effective at disinfecting contact lenses. | "Meets the requirements of both the stand-alone with organic load disinfection test and the regimen test." |
| Clinical Safety & Acceptability | Safe and acceptable for use by contact lens wearers; equivalent to predicate. | "A clinical trial of 3 months usage... by 50 subjects... showed the safety, acceptability and substantial equivalence of the Sauflon Multipurpose Solution to the predicate device." |
Study Details for Clinical Safety & Acceptability (as applicable for this product)
Since this is a solution, not a device with AI, the "test set" and "ground truth" concepts are interpreted differently. For the clinical study, the "test set" refers to the subjects using the product, and "ground truth" is established through clinical observations of safety and acceptability.
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2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Clinical Study): 50 subjects using Sauflon Multipurpose Solution.
- Control Group: 21 control subjects using AMO Complete Brand Multi-Purpose Solution - No Rub.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data beyond the submission being from "Twickenham, Middlesex TW1 3LP United Kingdom". The study is prospective, as it describes a 3-month usage period.
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3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not explicitly stated. The "ground truth" for a contact lens solution clinical study would typically involve clinical assessments by eye care practitioners or other medical professionals monitoring the subjects for adverse events, comfort, and other relevant outcomes. The document indicates the product is for use "as recommended by the eye care practitioner," implying expert involvement in monitoring but doesn't specify how many or their qualifications for establishing study "ground truth."
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4. Adjudication Method for the Test Set:
- Not described in the provided text. For a clinical study of this nature, adjudication of adverse events or safety concerns would typically be part of the protocol, but the method is not detailed here.
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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, this was not done. This type of study is relevant for diagnostic imaging AI devices, not for contact lens care solutions.
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6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, this was not done. This concept is only applicable to AI/algorithm-based devices. The "standalone" tests for this product were laboratory tests for sterility, preservative efficacy, and disinfection efficacy (as listed in section 7 of the 510(k) summary).
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7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):
- For the clinical study, the ground truth was based on clinical observations and subjective feedback from subjects regarding safety and acceptability over a 3-month period, likely assessed against outcomes data such as adverse event rates, comfort scores, and overall satisfaction, compared to the predicate device.
- For the pre-clinical (laboratory) tests (sterility, efficacy, etc.), the "ground truth" was established by defined laboratory standards and measurement protocols (e.g., USP requirements, specific disinfection test standards).
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8. The Sample Size for the Training Set:
- Not applicable. This product is a chemical solution, not an AI model that requires a "training set."
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9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set for an AI model.
§ 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.”