(80 days)
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.
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”