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Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, disinfection, removal of proteins, storage and conditioning of soft (hydrophilic) contact lenses including silicone hydrogel 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.

In the provided text, the device in question is "Sauflon Multipurpose Solution". The purpose of the 510(k) submission is to add the indication for use with Silicone Hydrogel Lenses, with the predicate device being Aquify Multi-Purpose Disinfecting Solution.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Clinical Trial: Circa 250 subjects.
   • Data Provenance: Not explicitly stated, but the submission is from a UK company, making it plausible the study was conducted there or internationally. The text does not specify if it was retrospective or prospective, but clinical trials are generally prospective.
   • Silicone Hydrogel Lens Compatibility: Tested with "4 representative marketed silicone hydrogel lenses."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • The document does not mention the use of experts to establish a "ground truth" in the traditional sense. The clinical study compares the new solution to a predicate device, focusing on safety and acceptability based on subject outcomes and observations, rather than expert interpretation of data points.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not specified. The clinical trial focused on safety and acceptability, which typically involves collection of adverse events, comfort scores, and other objective measures, rather than subjective adjudication by multiple experts.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiology AI), which is not applicable to a contact lens solution.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This device is a contact lens solution, not an algorithm. The "standalone" performance would refer to the chemical properties and biological effects of the solution, which were tested in pre-clinical (toxicology, microbiology) and clinical studies.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For pre-clinical studies (toxicology, microbiology, lens compatibility): The "ground truth" was established by objective laboratory test results against predefined standards (e.g., cytotoxicity assays, microbial kill rates, material compatibility assessments).
   • For clinical studies: The "ground truth" for safety and acceptability was established through clinical observations, reported adverse events, comfort questionnaires, and other objective measures from the 250 subjects, compared against the predicate device. This falls under outcomes data or clinical endpoints.

7. The sample size for the training set:

   • Not applicable. This is a contact lens solution, not an AI/machine learning algorithm that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as no training set was used.

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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

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.

• 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.

• 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."

• 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.

• 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.

• 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).

• 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).

• 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."

• 9. How the Ground Truth for the Training Set Was Established:

  • Not applicable. As above, no training set for an AI model.

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