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For use in the daily cleaning, reconditioning, rinsing, removing protein deposits, and reducing lipid deposition, 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 (MPDS) is a sterile, buffered, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, aminomethylpropanol, disodium EDTA, two wetting agents (TETRONIC® 1304) and HydraGlyde™ Moisture Matrix) with POLYQUAD® (polyquaternium-1) 0.001% and ALDOX® (myristamidopropyl dimethylamine) 0.0006% preservatives. HydraGlyde™ Moisture Matrix is a proprietary synthetic block copolymer that is primarily designed for wetting and lubricating silicone hydrogel lenses.

The provided text describes the Alcon Multi-Purpose Disinfecting Solution (MPDS) and its clearance through a 510(k) premarket notification. It outlines the safety and effectiveness studies conducted, but does not present acceptance criteria in a table format with numerical performance metrics for the device. The term "acceptance criteria" is used in a general sense, referring to compliance with guidelines.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

Acceptance Criteria and Device Performance Study for Alcon Multi-Purpose Disinfecting Solution (MPDS)

The Alcon Multi-Purpose Disinfecting Solution (MPDS) was evaluated against guidelines set forth in the FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products, as well as relevant ANSI and EN ISO standards for microbiological requirements (EN ISO 14729:2001) and antimicrobial preservative efficacy (EN ISO 14730:2000).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table. Instead, it refers to meeting established guidelines and demonstrating clinical equivalence or superiority. The reported performance is qualitative.

2. Sample Size and Data Provenance (for test set/clinical study)

• Sample Size: Not explicitly stated for the clinical study. The text only mentions "a clinical study was conducted" with "silicone hydrogel and soft (hydrophilic) contact lens wearers."
• Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "clinical study" and is prospective in nature, as it evaluates the safety and efficacy of the new Alcon MPDS in lens wearers.

3. Number of Experts and Qualifications (for ground truth)

• This information is not provided in the given text. For a medical device like a contact lens solution, ground truth regarding safety and efficacy in a clinical setting would typically be established by ophthalmologists or optometrists, but the number and qualifications of such experts are not detailed.

4. Adjudication Method (for test set)

• This information is not provided in the given text. While a clinical study was performed, the method of adjudicating outcomes (e.g., adverse events, comfort scores) is not described.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically relevant for diagnostic imaging AI devices, not for a contact lens care solution. Therefore, there is no effect size of human readers improving with or without AI assistance.

6. Standalone Performance (Algorithm only)

• No, a standalone (algorithm only) performance study was not conducted. This device is a chemical solution, not an AI algorithm. Its performance is inherent to its chemical formulation and interaction with biological and material components.

7. Type of Ground Truth Used (for test set)

• The ground truth for the clinical study would be based on clinical assessments and patient reports of outcomes (e.g., safety events, comfort levels, visual acuity where relevant) in comparison to the control product. For microbiological studies, ground truth is established by standard laboratory culture methods. For cleaning and compatibility, it's based on laboratory analytical methods.

8. Sample Size for the Training Set

• This concept is not applicable as the device is a chemical solution, not an AI algorithm that requires a training set. The development of the solution involved chemical formulation and in-vitro testing.

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

• This concept is not applicable for a chemical solution. The "ground truth" during development would be based on scientific principles, chemical analysis, and iterative testing in vitro to optimize the formulation for its intended functions (cleaning, disinfection, compatibility).

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ReNu MultiPlus Multi-Purpose Solution is indicated for use in daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

Bausch & Lomb ReNu Multi-Purpose Solution is a sterile, isotonic solution that contains HYDRANATE® (hydroxyalkyl phosphonate) as a protein deposit remover, poloxamine as a surface active agent and salts as tonicity and buffering agents; preserved with DYMED® (polvaminopropyl biguanide) 0.0001%. The product is indicated for use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.

The provided text describes a 510(k) Premarket Notification for the Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution. It details the device, its indications for use, and a clinical study conducted to demonstrate its safety and efficacy. However, the document does not contain a table of acceptance criteria or specific performance metrics (like sensitivity, specificity, accuracy, etc.) typically found when evaluating the performance of a device against numerical acceptance criteria.

The study described is a clinical study for a contact lens care solution, which focuses on safety and efficacy in terms of lens cleanliness and eye health, rather than a diagnostic or AI-driven device with quantifiable performance criteria like those for image analysis or disease detection.

Here's an attempt to answer the questions based on the available information, noting the limitations of the provided text:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide specific quantifiable performance metrics in terms of sensitivity, specificity, or similar measures typically associated with diagnostic or AI devices. The study's conclusion is qualitative: "Both regimens demonstrated clinically acceptable lens cleanliness. Safety and efficacy were demonstrated."

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

• Sample Size: Not explicitly stated in the provided text for the new clinical study. The text only mentions "A multi-site randomized, controlled clinical study."
• Data Provenance: The study was a "multi-site randomized, controlled clinical study," implying prospective data collection across various clinical sites. The country of origin is not specified, but the submission is to the U.S. FDA by a Rochester, New York-based company, suggesting the study likely involved U.S. sites.

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

This information is not provided in the document. For a contact lens solution, ground truth would likely involve clinical assessments by ophthalmologists or optometrists, but the number and qualifications are not specified.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study, as typically understood for diagnostic imaging or decision support AI, was not performed. The study mentioned compares ReNu MultiPlus solution with Alcon OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution (Control solution) in terms of "clinically acceptable lens cleanliness, safety and efficacy." This is a comparative study of two products, but not in the context of human readers improving with or without AI assistance.

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

This question is not applicable. The device is a contact lens care solution, not an algorithm or AI system. Its performance is evaluated through clinical use by human subjects, not as a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth was established through clinical assessment of lens cleanliness, safety (e.g., adverse events), and efficacy in human subjects. This would involve observations and evaluations by eye care practitioners.

8. The Sample Size for the Training Set

This question is not applicable. The device is a chemical solution, not an AI model that requires a training set. The clinical study described evaluates the product's performance directly.

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

This question is not applicable as there is no "training set" for this type of device.

Summary of Limitations:

The provided document is a 510(k) summary for a medical device (contact lens solution) and describes a clinical study to demonstrate its safety and efficacy for its intended use. The questions posed, however, are typically asked when evaluating diagnostic devices, particularly those involving Artificial Intelligence (AI) algorithms, which require specific metrics like sensitivity, specificity, sample sizes for training/test sets, expert adjudication, and ground truth methodologies (e.g., pathology, outcomes data). The information required to fully answer these questions in the context of an AI device is largely absent because the device being described is not an AI diagnostic tool.

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ReNu Multi-Purpose Solution is indicated for use in daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) lenses as recommended by your eye care practitioner.

Bausch & Lomb ReNu Multi-Purpose Solution is a sterile, isotonic solution that contains HYDRANATES (hydroxyalkyl phosphonate) as a protein deposit remover, poloxamine as a surface active agent and salts as tonicity and buffering agents; preserved with DYMED" (polyaminopropyl biguanide) 0.0001%. The product is indicated for use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. The sterile solution is contained in a plastic bottle and is labeled with a lot number and expiration date.

Here's an analysis of the provided text, focusing on the acceptance criteria and the studies that demonstrate the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Protein Cleaning Study: "Groups 1 and 4 lenses artificially soiled with lysozyme." The exact number of lenses or replicates is not specified.
  • Provenance: Not explicitly stated, but assumed to be laboratory-based (in-vitro).
• Microbiology Studies: Not explicitly stated for the "additional microbiological testing." Reference is made to previous submissions (K974723, K-002823, P860023/S12) for earlier studies.
  • Provenance: In-vitro laboratory studies.
• Clinical Studies: "A multi-site randomized, controlled clinical study." The exact number of subjects or lenses is not specified.
  • Provenance: Prospective clinical study. Country of origin not specified, but likely US-based given the FDA submission.

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

This information is not provided in the document for any of the studies. No mention of expert review or reconciliation for ground truth is made.

4. Adjudication Method (for the test set)

This information is not provided in the document. The studies described are either in-vitro technical tests or a clinical trial where clinical outcomes would likely be assessed by investigators and measured against pre-defined criteria, rather than using an adjudication panel in the sense often applied to AI model evaluations.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This device is a contact lens solution, not an AI or imaging diagnostic tool that would typically involve human "readers" or AI assistance in that context. The "clinical study" evaluates the solution's performance on its own, not in conjunction with human interpretation of results.

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

• Protein Cleaning Study: Yes, this was an in-vitro standalone test comparing the solution's cleaning efficacy against a control solution. There is no human interpretation component beyond observing the results.
• Microbiology Studies: Yes, these were standalone in-vitro tests (Stand-alone Procedure for Disinfecting Products) evaluating the solution's antimicrobial efficacy. There is no human user involvement in the performance evaluation itself.
• Clinical Studies: No, the clinical study involved human subjects using the product. While the performance of the solution itself is standalone (it disinfects/cleans on its own), the evaluation of its safety and efficacy is within a human-in-the-loop setting (patients using the product and being monitored). However, it's not a "standalone algorithm" in the typical sense of AI evaluation.

7. The Type of Ground Truth Used

• Protein Cleaning Study: The "ground truth" was established by artificially soiling lenses with lysozyme and then quantitatively or qualitatively assessing protein removal.
• Microbiology Studies: The "ground truth" was established by using standardized microbial challenges (specific types and concentrations of microorganisms) and measuring log reductions or kill rates according to established FDA-recognized test procedures.
• Clinical Studies: The "ground truth" for clinical safety and efficacy would have been based on clinical endpoints and observations (e.g., visual acuity, comfort, adverse events, lens deposition levels as assessed by ophthalmologists/optometrists) and objective measures of lens cleanliness.

8. The Sample Size for the Training Set

This information is not applicable as this is a contact lens solution and not an AI/machine learning device that requires a "training set." The studies performed are traditional chemistry, microbiology, and clinical performance evaluations.

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

This information is not applicable for the same reason as above.

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