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The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution is indicated for use in chemical (not heat) disinfection, daily cleaning, rinsing and storage of daily and extended wear soft contact lenses as recommended by the eye care practitioner.

A sterile, isotonic solution that contains Poloxamer, sodium phosphate buffer, sodium chloride, and disodium edetate; preserved with polyhexanide 0.0001%. Contains no chlorhexidine or thimerosal. Cleans, loosens and removes accumulations of films, deposits and debris from soft contact lenses. Destroys harmful microorganisms on the surface of the lens. Rinses, stores and rewets lenses before the lenses are placed on the eye.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution are primarily based on demonstrating substantial equivalence to existing, legally marketed predicate devices (specifically, Bausch and Lomb ReNu Multipurpose Solution). This means the device must perform as safely and effectively as the predicate device. The summary doesn't explicitly state quantitative acceptance criteria for each test in a pass/fail format with specific numerical thresholds. Instead, it reports outcomes which, upon review, were deemed to meet the substantial equivalence standard.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Trial):

  • Test Group: 246 subjects
  • Control Group: 117 subjects (59 using a commercially available multipurpose solution, 58 using a commercially available two-step peroxide system).
  • Data Provenance: The document does not explicitly state the country of origin for the clinical trial data. However, the submitter's address is in the UK and the official agent is in the US, suggesting a potential international or multi-site study, but no definitive statement is made. The study is prospective as it involved tracking subjects using the product over a period of at least three months.

• Test Set (Toxicological & Microbiological):

  • Agar Overlay Cytotoxicity: Representative lenses from all four groups of soft (hydrophilic) lens types.
  • Systemic Toxicity: Healthy mice, 50ml/kg body weight. (Specific number of mice not given).
  • Acute Oral Toxicity: Healthy rats, 5ml/kg body weight. (Specific number of rats not given).
  • Acute Ocular Irritation: Three rabbits.
  • USP Class VI Testing: Not specified, but involved extracts from bottles.
  • Sterility, Preservative Efficacy, Disinfection Efficacy: Not specified, but likely involved laboratory samples and standardized media.

3. Number of Experts and Qualifications for Ground Truth

• Clinical Study: The clinical trial involved 12 investigators. Their specific qualifications (e.g., ophthalmologist, optometrist, years of experience) are not specified in the provided summary. They reported symptoms, problems, complaints, and performed slit lamp examinations.
• Toxicological/Microbiological Studies: Not applicable in the same sense as clinical ground truth. These are laboratory tests with objective endpoints.

4. Adjudication Method for the Test Set

• Clinical Study: The summary does not describe a formal adjudication method for the clinical observations (slit lamp findings, symptoms). The data appears to be collected directly by the 12 investigators. However, the "Analysis of the discontinuations among the various groups...showed that the differences in the incidence of discontinuations for cause...were not statistically significant," suggesting a statistical comparison was performed.
• Laboratory Tests: Not applicable, as these are objective laboratory measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described. The clinical study was a comparison of a single product (Sauflon Multipurpose Solution) against two control product types, as used by subjects under the supervision of investigators. It was not a study evaluating human readers' diagnostic accuracy with or without AI assistance.

6. Standalone Performance

• Yes, standalone (algorithm only without human-in-the-loop performance) was implicitly done for the toxicological and microbiological tests. The solution itself was tested for its inherent properties (cytotoxicity, systemic toxicity, ocular irritation, sterility, preservative efficacy, disinfection efficacy, stability) independent of human interpretation of its effects on patients in the clinical study.

7. Type of Ground Truth Used

• Clinical Study: The "ground truth" for the clinical study was based on clinical observations and reported symptoms by human subjects and medical personnel (the 12 investigators). This includes slit lamp findings, adverse reactions, and subjective reports of discomfort or issues. Comparison was made to control groups using established products, indicating a comparative clinical "truth."
• Toxicological & Microbiological Tests: The ground truth for these tests was based on standardized, objective laboratory assays with predefined endpoints and pass/fail criteria (e.g., absence of cell lysis, no difference from control animals, reduction in microbial count).

8. Sample Size for the Training Set

• Training Set (for the reported clinical trial) NA: There is no explicit mention of a separate "training set" for the clinical study or any AI/algorithmic development. The clinical trial described in the submission served as the primary validation study for human use. The toxicological and microbiological studies would have been performed on laboratory samples, not human "training sets." This product is a chemical solution, not an AI/ML-driven device, so the concept of a "training set" for an algorithm as typically understood in AI is not directly applicable here. The product's formulation and design may have been informed by prior R&D data, but that's distinct from an AI training set.

9. How Ground Truth for Training Set Was Established

• As the device is a contact lens solution and not an AI or algorithm, the concept of a "training set" with established ground truth in the AI context does not directly apply. The formulation of the solution would have been developed based on chemical principles, known antimicrobial agents, surfactants, and buffers, guided by an understanding of ocular compatibility and cleaning efficacy. The various laboratory tests (cytotoxicity, microbiology, etc.) serve more as validation steps for the R&D, rather than "ground truth establishment" for an AI model.

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