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REFRESH® RELIEVA™ FOR CONTACTS is indicated to lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

REFRESH® RELIEVA™ FOR CONTACTS is a sterile, buffered, isotonic, preserved solution. This aqueous formulation includes carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%). The solution may also contain hydrochloric acid and/or sodium hydroxide to adjust pH. All ingredients except for Purite are compendial grade (USP/NF/Ph Eur). The product is supplied in a teal colored, low density polyethylene (LDPE) multi-dose bottle and tip with a teal colored high impact polystyrene (HIPS) cap. The bottles are further packaged in paper cartons with a patient information insert.

This document is a 510(k) Summary for the REFRESH® RELIEVA™ FOR CONTACTS device. It describes the device, compares it to predicate devices, and summarizes testing performed to support its substantial equivalence. The document is a regulatory submission for a medical device and does not inherently describe a study that uses AI, nor does it provide detailed acceptance criteria related to AI performance.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable as this document pertains to a medical device (contact lens solution), not an AI/ML powered device.

However, I can extract the information relevant to the performance of the device as described in this document.

Device Name: REFRESH® RELIEVA™ FOR CONTACTS

Device Description: A sterile, buffered, isotonic, preserved solution containing carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%).

Indications for Use: To lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

Predicate Devices:

• REFRESH® Contacts Lubricating and Rewetting Drops (K992028)
• REFRESH OPTIVE CONTACTS Lubricating and Rewetting Drops (K083812)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance in the typical sense of numerical thresholds for sensitivity, specificity, or similar metrics for an AI/ML device. Instead, the "acceptance criteria" are implied by the requirement for "substantial equivalence" to predicate devices, which the studies aimed to demonstrate. The performance is reported in terms of safety and efficacy.

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

• Sample Size for Test Set:

  • Clinical Study: The document states "A 3-month clinical study was conducted... in contact lens wearers." However, the exact number of participants (sample size) in this clinical study is not provided in the available text.
  • Biocompatibility/Stability: Not applicable as these are bench/lab tests, not human test sets.

• Data Provenance: Not explicitly stated (e.g., country of origin). The clinical study was conducted to evaluate the device against a marketed predicate, implying a controlled clinical trial setting. The studies are prospective as they were specifically performed to support the 510(k) submission.

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

This section is not applicable as the described studies are for a contact lens solution, not an AI/ML powered device where expert readers typically establish ground truth. Clinical endpoints in this context would likely be based on participant reporting of symptoms and potentially objective ophthalmological assessments, not "expert ground truth" for image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. Clinical study endpoints would be collected and analyzed, but "adjudication" in the sense of resolving discrepancies between expert interpretations of data (as typically seen in AI/ML performance studies) is not relevant 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

This section is not applicable. This document describes the safety and effectiveness testing for a contact lens comfort solution, not an AI/ML diagnostic or assistive device. There are no "human readers" interpreting images with or without AI assistance in this context.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. The device is a physical product (contact lens solution), not an algorithm.

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

For the clinical study, the "ground truth" or primary endpoints would likely be based on:

• Patient-reported outcomes (PROs): Subjective relief of dryness, discomfort, and irritation; comfort upon lens insertion.
• Clinical assessments: Potentially objective measures of ocular surface health or lens-eye interaction, as assessed by an optometrist or ophthalmologist, though specific measures are not detailed in this summary.
• The study aimed to demonstrate substantial equivalence in safety and efficacy compared to a predicate device, meaning its performance was judged against the established acceptable performance of the predicate.

For biocompatibility, the ground truth involves adherence to and successful completion of established test methods (e.g., cytotoxicity, irritation, sensitization) as per FDA guidance.

For stability, the ground truth involves chemical, physical, and microbiological specifications being met over time.

8. The sample size for the training set

This section is not applicable. The device is a contact lens solution, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the reasons stated above.

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