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TRADE NAME Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:

• Chemically (NOT HEAT) Disinfect
• Clean
• Rinse
• Store
• Remove Protein

TRADE NAME Multipurpose Solution is a sterile, isotonic, buffered, aqueous solution containing sodium chloride, potassium chloride, phosphate buffer, edetate disodium, and Poloxamer 237 with polyhexamethylene biguanide 0.0001% as a preservative. As with COMPLETE® brand Multi-Purpose Solution, this product is a clear, coloriess solution, packaged in the same plastic bottles with controlled dropper tips.

Acceptance Criteria and Study for Allergan TRADE NAME Multipurpose Solution

The provided document describes the acceptance criteria and supporting studies for Allergan's "TRADE NAME Multipurpose Solution," which is a soft (hydrophilic) contact lens care product. The submission is a 510(k) premarket notification, seeking substantial equivalence to predicate devices (COMPLETE® brand Multi-Purpose Solution, K003252 and K013479). The key change in the new product is the removal of the lubricant HPMC, leading to the deletion of the "conditioning" claim. Therefore, the studies primarily focus on demonstrating that removing HPMC does not negatively impact the remaining indicated uses and that the new formulation is comparable to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a non-clinical device (not an AI/ML medical device as would typically have performance metrics like sensitivity/specificity), the "acceptance criteria" are based on demonstrating equivalence to the predicate device. The performance is assessed through various nonclinical studies.

2. Sample Size and Data Provenance

The document does not specify exact sample sizes for each study, but provides the following details:

• Solution Compatibility: Used FDA Group I and IV soft contact lenses for 30 cycles.
• Cleaning Studies: Used Group I and IV lenses over a 30-day/30-cycle period.
• Toxicological Studies (In-vivo): A 21-day rabbit study was performed.
• Data Provenance: The studies were conducted by Allergan, presumably in the USA. Given the submission date (2002), these are retrospective studies on the newly formulated product.

3. Number of Experts and Qualifications for Ground Truth

This type of product (contact lens solution) does not typically involve human expert adjudication for ground truth in the way a diagnostic AI/ML device would. The "ground truth" for the non-clinical studies is based on objective measurements and established laboratory protocols.

• Solution Compatibility/Cleaning: Assessment of lens parameters (diameter, power, basecurve), integrity, visual appearance, and presence of deposits would be performed by lab technicians or scientists following standardized procedures.
• Microbiological Studies: Efficacy against microorganisms assessed via standardized microbiological assays.
• Toxicological Studies: In-vitro cytotoxicity assessed by laboratory techniques. In-vivo rabbit study would involve veterinarians or toxicologists assessing ocular effects, but the document doesn't specify a "number of experts" or their specific qualifications beyond what implied for such studies.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this submission concerns non-clinical performance of a contact lens solution, not an AI/ML diagnostic system requiring human adjudication of results. The results are based on objective laboratory measurements and observations.

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

Not applicable. This is not an AI/ML device, and no human reader performance is being evaluated or compared with or without AI assistance. The studies assess the intrinsic properties and performance of the contact lens solution itself.

6. Standalone (Algorithm Only) Performance

Not applicable. This is not an algorithm based device. The "device" is a chemical solution. The studies describe the standalone performance of the solution as a product.

7. Type of Ground Truth Used

The ground truth for these studies is based on:

• Objective measurements: E.g., lens diameter, power, basecurve changes, protein removal percentages, cytotoxicity levels.
• Standardized protocols and assays: E.g., for microbiological efficacy, cleaning effectiveness.
• Veterinary/Toxicological observations: For the in-vivo rabbit study regarding ocular effects.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "formulation" is the "design" of the product, which is then tested.

9. How Ground Truth for the Training Set Was Established

Not applicable, for the same reason as point 8.

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COMPLETE® brand Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:

• Chemically (NOT HEAT) Disinfect
• Clean
• Rinse
• Store
• Remove Protein
• Condition

There are no formulation or other changes in the device description.

The provided document describes the 510(k) summary for Allergan's COMPLETE® brand Multi-Purpose Solution. It details a clinical study conducted to demonstrate the substantial equivalence of a modified cleaning regimen with the existing standard regimen.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The device (COMPLETE® brand Multi-Purpose Solution with modified cleaning regimen) was evaluated for its non-inferiority compared to the standard regimen. The primary acceptability criterion was the mean change from baseline in lens comfort score.

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

• Sample Size (Clinical Study): 157 subjects were enrolled. 151 subjects completed the study.
• Data Provenance: The document does not explicitly state the country of origin. However, Allergan is based in Irvine, California, USA, and the submission is to the US FDA, which implies the study was likely conducted within the USA or aligned with US regulatory standards. The study was prospective, as it involved enrolling subjects and randomizing them to different regimens over a three-month period.

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

The document does not specify the number of experts or their qualifications for establishing ground truth within the clinical study. However, it mentions that nine investigators enrolled the subjects. It's implied that these investigators, likely eye care professionals, were responsible for evaluating lens comfort, symptoms of discomfort, and performing slit lamp examinations which contributed to the clinical ground truth. Their specific qualifications (e.g., ophthalmologist, optometrist, years of experience) are not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (such as 2+1 or 3+1 for resolving discrepancies). The clinical data likely rely on the assessments made by the individual investigators at each study site, potentially with standardized protocols for evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described in the provided text. This study was a clinical trial comparing two active treatment regimens (standard vs. modified) of the same product, rather than comparing human readers' performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This study relates to a contact lens care solution, a physical product used by humans, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this submission. The effectiveness of the solution is inherently tied to human use. The microbiological and cleaning effectiveness studies could be considered "standalone" in that they evaluate the product's intrinsic properties without human physiological interaction, but this is distinct from AI/algorithm standalone performance.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on a combination of:

• Expert Clinical Assessment: Mean change from baseline in lens comfort score, symptoms of discomfort, slit lamp examination findings (e.g., edema, neovascularization, hyperemia), visual acuity, and other ocular parameters assessed by the investigators.
• Subjective Patient Reporting: Subject ratings of comfort, vision quality, and self-reported symptoms.
• Laboratory Analysis: For cleaning effectiveness (surface deposits and general condition of lenses returned to Allergan).
• Standardized Microbiological and Toxicological Testing: As per FDA and USP guidelines.

8. The Sample Size for the Training Set

The document describes a single clinical study of 157 subjects (151 completed) that serves as the basis for the 510(k) submission. It does not mention a separate "training set" in the context of device development or machine learning. This study is the primary evidence for the modified regimen.

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

As no separate "training set" is described in the context of machine learning, this question is not applicable to the provided information. The ground truth for the clinical study was established as described in point 7.

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