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For use in the daily cleaning, conditioning, rinsing, removing protein deposits, chemical (not heat) disinfection, and storage of silicone hydrogel and soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

ALCON® Multi-Purpose Disinfecting Solution can also be used with OPTI-FREE® SUPRACLENS® Daily Protein Remover.

ALCON® Multi-Purpose Disinfecting Solution is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, sodium borate, propylene glycol, a proprietary dual action conditioning system (Tetronic® 1304t, nonanoyl ethylenediaminetriacetic acid) with POLYQUAD® (polyquaternium-1) 0.001% and ALDOX® (myristamidopropyl dimethylamine) 0.0005% as preservatives.

The provided text describes the Alcon Multi-Purpose Disinfecting Solution, a contact lens care product, and its submission for 510(k) premarket notification. The document details safety and effectiveness studies conducted to demonstrate its substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information, specifically focusing on what can be extracted from the provided text for a device performance evaluation:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in a quantitative, pass/fail format with specific performance metrics defined beforehand. Instead, it refers to meeting "guidelines" and "standards" and then reports study results. However, we can infer acceptance criteria based on the standards cited and the reported outcomes.

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

The document provides information on clinical studies but does not explicitly define a "test set" in the context of an algorithm's performance evaluation as might be expected for an AI device. Instead, it describes clinical trials.

• Clinical Studies (Safety and Efficacy):
  • One three-month clinical study with asymptomatic soft (hydrophilic) lens wearers.
  • One one-month study with silicone hydrogel lens wearers.
  • One one-month study with symptomatic soft (hydrophilic) lens wearers.
  • An additional clinical study for wettability evaluation (also cited in wettability studies section).
• Sample Size: The exact number of subjects in each clinical study is not provided.
• Data Provenance: The document does not specify the country of origin for the clinical study data or explicitly state whether they were retrospective or prospective. Given they are described as "clinical studies" and compare "regimens," they are inherently prospective.

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

This information is not provided in the document. The studies described are clinical trials evaluating the product's performance in human subjects, not a diagnostic algorithm where expert consensus might establish a "ground truth" for a specific condition. Evaluations would likely be conducted by optometrists or ophthalmologists, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. As detailed above, the context is not an algorithm performance evaluation where expert adjudication of results would be typical. Clinical trial outcomes would be assessed based on established clinical endpoints and measurements.

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

• No Multi-Reader Multi-Case (MRMC) Study was done. The device is a contact lens care solution, not an AI-powered diagnostic tool.
• No AI assistance is involved. Therefore, there is no effect size related to human reader improvement with or without AI.

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

• No standalone algorithm performance was done. The device is a physical product (contact lens solution), not an algorithm.

7. The Type of Ground Truth Used

For this type of device (contact lens solution):

• Clinical Ground Truth: Clinical studies assessed various parameters like comfort levels, lens deposits, corneal staining, and wettability. These are direct measurements of physiological responses or visual assessments made by clinicians.
• Microbiological Ground Truth: For efficacy, laboratory standards (e.g., FDA Guidance, EN ISO 14729) define target log reductions for specific microorganisms, which serve as the "ground truth" for antimicrobial activity.
• Chemical/Physical Ground Truth: Cleaning efficacy (CMC), compatibility, and wettability studies use scientific measurements and established physical/chemical principles.

8. The Sample Size for the Training Set

• Not applicable. The device is a contact lens solution, not an AI model. Therefore, there is no "training set." The product's formulation and associated laboratory testing could be considered its developmental "training," but not in the context of machine learning.

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

• Not applicable. As there is no training set for an AI model, this question does not apply. The "ground truth" for the product's development and pre-clinical testing would be established through established scientific methods, chemical analysis, in vitro microbiological assays, and compatibility testing with known lens materials.

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For the daily cleaning, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. For use in chemical (not heat) disinfection.

Alcon Multi-Purpose Disinfecting Solution ID 90746 can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Alcon Multi-Purpose Disinfecting Solution ID 90746 is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, tetronic 1304, with edetate disodium 0.05%, Polyquaternium-1) 0.001% and AL-6289 0.0005% as preservatives.

The provided text describes the regulatory submission for a contact lens care product, "Alcon Multi-Purpose Disinfecting Solution ID 90746," and its approval based on substantial equivalence to existing devices. The document outlines microbiological studies, preclinical toxicology tests, and a clinical study to demonstrate safety and efficacy.

Here's an analysis of the acceptance criteria and study information, extracting what is available and noting what is not explicitly stated in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Clinical Study Test Set: "65 patients/130 eyes - 3 months".
• Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "clinical," implying prospective data collection for the purpose of the submission.

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

• This information is not provided in the text. The clinical study evaluated safety and efficacy; however, it doesn't describe an "expert ground truth" for a classification task in the way a diagnostic device might. The outcome measures would be related to clinical observations by medical professionals involved in the study, but their specific roles or number for establishing a ground truth are not detailed.

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

• This information is not provided in the text.

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 is not applicable. The device is a contact lens care solution, not an AI-assisted diagnostic or imaging tool involving human readers.

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

• This is not applicable. The device is a contact lens care solution and does not involve an algorithm with standalone performance. Its effectiveness is based on chemical and physical properties and their interaction with lenses and biological systems.

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

• For the Microbiological Studies: The ground truth was based on the "FDA Guidelines for contact lens solutions" and "Stand-Alone criteria for disinfection." These are established regulatory and industry standards for germicidal efficacy.
• For Preclinical Toxicology: Ground truth for safety was established through standardized toxicology tests like "cytotoxicity (agar overlay)" and "ocular safety (irritation) evaluations."
• For Compatibility/Cleaning Efficacy: Ground truth for compatibility and cleaning efficacy was established through laboratory studies evaluating interaction with lenses and removal of deposited materials.
• For the Clinical Study: The ground truth for safety and efficacy would have been based on clinical observations and assessments by ophthalmologists or optometrists involved in the study, measuring parameters related to lens comfort, ocular health, and cleaning performance over the 3-month period. The text does not specify exact outcome measures beyond "safe and effective."

8. The sample size for the training set

• This is not applicable as the device is not an AI/ML algorithm that requires a "training set." The development of the solution would involve formulation and laboratory testing, but not in the context of a machine learning training set.

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

• This is not applicable for the reasons stated in point 8.

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For the daily cleaning, rinsing, disinfecting and storing of soft (hydrophilic) contact lenses. For use in chemical (not heat) disinfection. Alcon Multi-Purpose Solution ID 90746 can also be used as a diluent for OPTI-ZYME® Enzymatic Cleaner.

Alcon Multi-Purpose Disinfecting Solution ID 90746 is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, tetronic 1304, with edetate disodium 0.05%, Polyquad (polyquaternium-1) 0.0001% and AL-6289 0.0005% as preservatives.

The provided text describes the regulatory submission for the Alcon Multi-Purpose Disinfecting Solution ID 90746, a contact lens care product. As such, the "device" in question is a chemical solution, not a medical imaging or AI-driven diagnostic device. Therefore, many of the typical acceptance criteria and study components related to software-as-a-medical-device (SaMD) or AI product evaluations (like sample size for test sets, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context.

However, I can extract the relevant information regarding acceptance criteria and the studies performed for this specific product as provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

• Finished product is effectively preserved by FDA standards.
• Finished product conforms to USP sterility requirements. |
  | Preclinical Toxicology (Safety) | Substantiation of safety for cleaning, rinsing, chemical disinfection, and overnight storage of all soft (hydrophilic) contact lenses (Group I, II, III, and IV). | - Acute oral toxicity studies conducted.
• Cytotoxicity (agar overlay) studies conducted.
• Mutagenicity (Ames test) studies conducted.
• Sensitization/allergic potential (guinea pig maximization test) studies conducted.
• Ophthalmic container safety studies conducted.
• Ocular safety (irritation) evaluations conducted.
• Conclusion: Should not present an ocular hazard to the consumer when used under recommended regimens. |
  | Compatibility/Cleaning Efficacy | Determine product compatibility with soft contact lenses and its ability to clean laboratory-deposited lenses. | - Demonstrated compatibility with soft contact lenses.
• Demonstrated cleaning efficacy for laboratory-deposited lenses. |
  | Clinical Safety & Efficacy | Evaluate safety and efficacy for cleaning, rinsing, disinfection, and storage of all soft (hydrophilic) contact lenses. | - Demonstrated safety and efficacy in a clinical study. |

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

• Microbiological Studies: Not specified, but generally refers to standard in-vitro laboratory testing as per FDA guidelines.
• Preclinical Toxicology: Not specified for each test, but standard toxicology models (e.g., guinea pigs for sensitization, Ames test for mutagenicity) would have accepted sample sizes for each.
• Compatibility/Cleaning Efficacy: Not specified, generally laboratory-based testing using various lens types with deposited materials.
• Clinical Study:
  • Sample Size: 249 patients (498 eyes) for 3 months; 121 patients (242 eyes) extending to 6 months.
  • Data Provenance: Not explicitly stated, but clinical trials for FDA submissions are typically conducted in the US or under internationally recognized good clinical practice (GCP) guidelines. It's a prospective study given it's a clinical trial for a new product.

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

• This is not applicable as the product is a contact lens solution, not an AI or imaging device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" would be the direct measurement of microbiological kill, absence of toxicity, and clinical outcomes based on patient health.

4. Adjudication Method for the Test Set

• Not applicable as this is not an interpretive diagnostic device. Clinical outcomes would be assessed by clinical investigators, and lab results by trained technicians.

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

• Not applicable. This is not an AI diagnostic device.

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

• Not applicable as this is a chemical solution, not an algorithm. The microbiological and preclinical tests can be considered "standalone" in the sense that they evaluate the product's inherent properties without user interaction beyond recommended usage.

7. The Type of Ground Truth Used

• Microbiological Studies: Direct measurements of microbial reduction/kill (e.g., colony-forming units), and adherence to USP sterility standards.
• Preclinical Toxicology: Histopathological examination, physiological measurements, and observation of adverse effects in animal models or cell cultures as per standard toxicology protocols.
• Compatibility/Cleaning Efficacy: Direct measurement of material effects on lenses and quantification of removed deposits.
• Clinical Study: Patient ocular health assessments (e.g., slit lamp examination, visual acuity), comfort ratings, and incidence of adverse events, assessed by ophthalmologists or optometrists.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

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