Search Results

AQuify Multipurpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting and storing soft (hydrophilic)lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. AQuify Multipurpose Solution is also indicated for daily protein removal when used with the no rub directions for use.

AQuify Multi-Purpose Solution is a sterile aqueous solution containing dexpanthenol, preserved with polyhexanide 0.0001%. pluronic F127, edetate disodium dehydrate, sorbitol, tromethamine, sodium phosphate dihydrogren, and purified water.

The provided text describes the safety and effectiveness studies for AQuify Multipurpose Solution, comparing it to predicate devices, particularly ReNu Multipurpose Solution. Here's an analysis of the acceptance criteria and study details based on the input:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with pass/fail thresholds. Instead, it describes studies and their findings, concluding that AQuify Multipurpose Solution is "substantially equivalent" to the predicate device. The performance is reported in terms of statistical significance and preference compared to the control.

Here's a table summarizing the findings as they relate to implied acceptance:

Study Details

The primary study mentioned for clinical evaluation is a "three-month prospective, randomized, single masked trial."

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a number. The text mentions "over 50% of the subjects expressing a preference" by the final visit, suggesting a sizable cohort was involved, but the exact N is not provided.
   • Data Provenance: Prospective. The study was a "three-month prospective, randomized, single masked trial." Country of origin is not specified but implicitly in the USA as it's a 510(k) submission to the FDA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document describes a clinical trial where subjects reported symptoms and efficacy scores, and an "investigator appraisal" for lens deposits and wetting.
   • Number of Experts: Not specified.
   • Qualifications of Experts: The "investigator" who performed appraisals would likely be an eye care professional (e.g., optometrist or ophthalmologist), but specific qualifications (e.g., years of experience) are not provided. The subjects themselves provided "ground truth" for subjective measures like comfort and dryness.

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

   • Adjudication methods like 2+1 or 3+1 are typically for reconciling discrepancies in expert interpretations of images or findings. This study primarily relies on direct subject reporting of subjective measures and investigator appraisal for objective measures.
   • Adjudication Method: Not applicable/Not mentioned. The study design ("single masked trial," "contra-lateral basis") means subjects compared the products on their own eyes, minimizing the need for adjudication of differing subjective experiences. Objective appraisals (e.g., dark field image analysis) would have predefined criteria.

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:

   • MRMC Study: No, this was not an MRMC study. This study evaluated the performance of a contact lens solution, not an AI-assisted diagnostic tool.

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

   • Standalone Performance: Not applicable. This device is a contact lens solution, not an algorithm. Its performance is evaluated through direct use (cleaning, disinfection, clinical comfort/dryness) or laboratory testing (microbiology, water content).

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

   • For Clinical Efficacy/Safety: Subjective self-reported data from study participants (e.g., comfort scores, dryness scores, preferences) and objective investigator appraisal (lens deposits, front surface wetting, dark-field image analysis).
   • For Microbiology/Cleaning/Dehydration: Laboratory standard tests, likely with pre-defined pass/fail criteria from regulatory guidance (e.g., FDA guidance, USP standards).

7. The sample size for the training set:

   • Not applicable. This is a medical device (contact lens solution), not a machine learning model, so there is no "training set."

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

   • Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Karats Multi-Purpose Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, protein removal and storing soft (hydrophilic) lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.

Karats Multi-Purpose Solution is a sterile aqueous solution containing sorbitol, tromethamine, pluronic F127, sodium phosphate dihydrogren, dexpanthnol, edetate disodium dihydrate and preserved with polyhexanide 0.0001

The provided text describes the 510(k) summary for KARATS Multi-purpose Solution, a contact lens care product. It details various studies conducted to demonstrate its safety and substantial equivalence to other marketed solutions. However, the document does not present specific acceptance criteria in a table format alongside device performance data for each claim. Instead, it generally states that the product meets guidelines or demonstrates substantial equivalence.

Here's an attempt to extract and infer the information based on the provided text, acknowledging that specific acceptance values are not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document frequently refers to "substantial equivalence" and meeting "guidelines" without providing the specific numerical or qualitative targets for these criteria. The "reported device performance" directly quotes or paraphrases the document's findings.

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

• Sample Size:
  • Silicone Hydrogel Lens Compatibility: Not explicitly stated, but implies multiple lenses were tested for "measured properties."
  • Surface Analysis (XPS): Not explicitly stated, but mentions "lens samples were processed and analyzed."
  • In Vitro Cleaning Efficacy: Not explicitly stated.
  • Cytotoxicity: Not explicitly stated.
  • Microbiology: Not explicitly stated.
  • Clinical Testing: Not explicitly stated.
• Data Provenance: The document does not specify the country of origin of the data. The studies were pre-clinical and clinical, indicating both laboratory and human subject studies. No information is given about whether the studies were retrospective or prospective, though clinical studies are generally prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The document does not mention using experts to establish ground truth for any of the studies described. The assessments appear to be based on laboratory measurements (e.g., optical/physical changes, XPS, in vitro efficacy, cytotoxicity, microbiological testing) and clinical observations, not expert consensus on an annotated dataset.

4. Adjudication Method for the Test Set

• None stated or implied. As ground truth was not established by human experts, there would be no need for an adjudication method.

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

• No. The document describes studies for a contact lens solution, not an AI-assisted diagnostic device. A MRMC study with human readers and AI assistance is not applicable here.

6. Standalone Performance Study

• Yes, for microbiological efficacy. The document explicitly states: "These studies demonstrate that KARATS meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products." This indicates the solution's performance was assessed independently against established criteria. Other pre-clinical studies (e.g., cytotoxicity, in vitro cleaning) also represent standalone assessments of the product's properties.

7. Type of Ground Truth Used

The "ground truth" for KARATS Multi-purpose Solution appears to be:

• Laboratory Measurements/Analytical Standards: For silicone hydrogel compatibility (optical/physical changes), XPS (surface changes), in vitro cleaning efficacy (protein removal), cytotoxicity (cell viability/irritation), and microbiology (disinfection efficacy against specific organisms). These are typically quantitative or qualitative outcomes measured in a controlled lab setting against predefined success criteria (e.g., "no significant difference," "non-cytotoxic," "meets stand-alone criteria").
• Clinical Observations/Outcomes: For clinical testing, data likely involved patient reported outcomes, adverse event rates, and physician assessments to demonstrate "substantial equivalence."

8. Sample Size for the Training Set

• Not applicable / Not stated. This is a pre-AI era medical device submission (2003) for a chemical solution, not an AI/ML algorithm. Therefore, there is no concept of a "training set" in the context of machine learning. The studies involved testing the solution directly.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided document.

Ask a specific question about this device