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Use AQuify Lens Comfort Drops to moisten, cushion, refresh, and provide temporary relief from dryness and irritation associated with contact lens wearing.

AQuify Lens Comfort Drops is a sterile solution containing sodium hyaluronate, sodium chloride, sodium phosphate and sodium perborate stabilized with phosphoric acid as a preservative.

The provided text is a 510(k) summary for AQuify Lens Comfort Drops. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. MRMC comparative effectiveness study results
6. Standalone performance details
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document explicitly states:

• "Non-clinical: No new studies performed. Non-clinical data from K013204 should be referenced."
• "Discussion of Clinical Data: Clinical data ." (This line is incomplete in the original document, suggesting no new clinical data is presented here).
• "The purpose of this application is to provide a more descriptive "action to the package insert for AQuify Lens Comfort Drops. There were no changes to the product formulation. Application, K013204 has already established the substantial equivalence of the product. The clinical data provide in the application supports that AQuify Lens Comfort Drops is substantially equivalent to Complete Blink-N-Clean."

This indicates that K042176 is primarily focusing on a labeling change and relies on previously submitted data (K013204) for establishing substantial equivalence. The detailed study information you're asking for would likely be found in the K013204 submission, not in this document.

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Use AQuify Lens Comfort Drops to moisten, cushion, refresh, and provide temporary relief from dryness and irritation associated with contact lens wearing.

AQuify Lens Comfort Drops is a sterile solution containing sodium hyalvronate, sodium chloride, sodium phosphate and sodium perborate stabilized with phosphoric acid as a preservative.

The provided text describes the safety and effectiveness studies for "AQuify Lens Comfort Drops" to demonstrate its substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and providing device performance metrics in a table. The document focuses on showing the product is non-toxic, non-irritant, microbiologically safe, and lens-compatible, aligning with existing FDA-approved products. There is no mention of AI or machine learning in the provided document, so queries related to those topics cannot be answered.

Here's a breakdown of the information that can be extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a table format with corresponding device performance values. Instead, it describes general findings and statements of equivalence. For example:

• Lens Compatibility: "no significant difference between AQuify Lens Comfort Drops and the control solution... The results further showed that the changes observed in lens power and diameter were within ANSI specifications."
• Cytotoxicity: "demonstrated that AQuify Lens Comfort Drops is non-cytotoxic and is a non-irritant."
• Microbiological: "The solution met the acceptance criteria for the ISO/FDA Preservative Effectiveness Test."
• Clinical Testing: "demonstrated no differences in biomicroscopy findings, symptoms, or vision safety ... In addition, there were no adverse differences for shown in the test cell for lens surface addition, there were no advertive ratings."

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

• Test Set Sample Size:
  • Clinical Testing: A "one month clinical study" was conducted. The exact number of subjects or lenses in this study is not specified.
  • Lens Compatibility, Cytotoxicity, Microbiological: Sample sizes for these tests are not provided.
• Data Provenance: Not explicitly stated, but clinical and preclinical studies were conducted by CIBA Vision Corporation. No specific country of origin for data is mentioned. The studies appear to be prospective studies designed to support the 510(k) submission.

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

This information is not provided in the document. The studies mentioned are primarily laboratory-based (cytotoxicity, microbiological, lens compatibility) and a clinical study assessing equivalence based on patient symptoms, biomicroscopy, and vision safety. There is no mention of "experts" establish a ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable/not mentioned. The studies described are not of a nature that would typically involve an adjudication method (such as review of complex diagnostic images).

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document does not describe AI assistance or human-in-the-loop performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, this is not applicable. The device is a lens comfort drop, not an algorithm.

7. Type of Ground Truth Used

• Lens Compatibility: Measured optical and physical properties of lenses against control solution and ANSI specifications.
• Cytotoxicity: Laboratory assays demonstrating non-cytotoxicity and non-irritancy.
• Microbiological: Adherence to "ISO/FDA Preservative Effectiveness Test" criteria.
• Clinical Testing: Biomicroscopy findings, reported symptoms, and vision safety assessments in comparison to a predicate device.

8. Sample Size for the Training Set

Not applicable. The document describes safety and equivalence studies for a medical device (comfort drops), not an AI/ML algorithm that requires a "training set."

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

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

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