Search Results

The ProGuard™ Lens Case is indicated for storage of soft (hydrophilic) contact lenses with AQuify® Multipurpose Solution.

Data indicate that lens cases are a significant source of microbial contamination. The ProGuard Lens Case is a contact lens storage case that is infused with silver to help minimize contamination on the lens case surface. Laboratory testing showed that the silver ions reduce bacterial growth of Pseudomonas aeruginosa and Citrobacter amalonaticus on the case surface after 24 hours. No significant reduction was observed in the ProGuard lens case with S.epidermidis, S. aureus, P. mirabilis and S. marcescens (2 isolates).

The provided text describes the "ProGuard Lens Case" and its performance in various studies. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" isn't explicitly defined with numerical thresholds in the document. Instead, the studies aim to demonstrate "substantial equivalence" to a predicate device and "significant reduction" in bacterial contamination. Based on the reported findings, here's a table summarizing the performance:

2. Sample Size Used for the Test Set and Data Provenance

• Direct Microbial Challenge Studies:

  • Sample Size:
    • 8 bacteria isolates were tested.
    • ProGuard lens cases and "regular lens cases" were exposed, but the exact number of cases per group isn't specified (e.g., how many ProGuard cases vs. how many regular cases were used for each isolate).
  • Data Provenance: Retrospective (laboratory testing). No country of origin is specified, but given the submitter's location (Georgia, USA), it's likely U.S. based.

• Clinical Study #1:

  • Sample Size: 39 subjects. Each subject used one ProGuard bowl and one control case bowl.
  • Data Provenance: Prospective (one-month clinical trial). No country of origin is specified, but again, likely U.S. based due to the submitter.

• Clinical Study #2:

  • Sample Size: 40 subjects. Each subject used one ProGuard bowl and one control lens case bowl.
  • Data Provenance: Prospective (one-month clinical trial). No country of origin is specified, but likely U.S. based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish ground truth for the test sets.

• For the microbiology studies, ground truth was established by laboratory methods (culturing and counting bacteria), not by human expert opinion.
• For the biocompatibility studies, ground truth was established by standardized tests (USP, ISO) with measurable endpoints (e.g., reactivity grade, ocular scores) which typically don't involve subjective expert consensus for "ground truth."
• For the clinical studies, the "ground truth" was the measured bacterial contamination level determined by laboratory analysis of the collected cases, not by expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method for the test set.

• The studies described rely on objective laboratory measurements (bacterial counts, silver concentration, reactivity grades, ocular scores) or statistical comparisons of these measurements. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of data (e.g., imaging studies where multiple readers interpret images and a tie-breaker is needed).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This type of study (MRMC for AI assistance) is not relevant to this device, which is a contact lens case, not an AI-powered diagnostic or interpretive tool. There is no AI component involved, nor are human readers interpreting data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device (ProGuard Lens Case) is a physical medical device, not an algorithm. Therefore, there is no "standalone algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The ground truth used in these studies varied by the type of non-clinical and clinical evaluation:

• Microbiology Studies (Direct Challenge & Clinical):
  • Bacterial Counts/Contamination Levels: Determined by laboratory methods (culturing, enumeration), which is a form of laboratory-confirmed outcome or direct measurement.
• Biocompatibility Studies (Cytotoxicity, Ocular Irritation, Systemic Toxicity):
  • Standardized Test Results: Based on established protocols like USP and ISO, yielding objective measurements like Reactivity Grade, Ocular Scores, and observations of systemic toxicity. This is a form of objective measurement against established standards.
• Silver Determination:
  • Concentration Measurement: Determined by Atomic Absorption (AA) spectroscopy, which is a direct analytical measurement.

8. The Sample Size for the Training Set

Not Applicable. The ProGuard Lens Case is a physical medical device. It is not an AI algorithm that requires a "training set" in the machine learning sense. The testing performed involved demonstrating safety and effectiveness directly through non-clinical and clinical studies, not by training a model.

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

Not Applicable (as explained in point 8).

Ask a specific question about this device