(127 days)
Bausch & Lomb ReNu MultiPlus™ Lubricating & Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses during wear. The product may be used with daily wear or extended wear lenses and with disposable lenses or lenses prescribed for frequent replacement.
Bausch & Lomb ReNu MultiPlus Lubricating & Rewetting Drops is a sterile, buffered, isotonic solution containing the demulcent povidone. The solution is preserved with edetate disodium and sorbic acid, both at a concentration of 0.1%. Boric acid, potassium chloride, sodium borate and sodium chloride act as buffering and tonicity agents. The solution is supplied sterile in a low density polyethylene bottle labeled with a lot number and expiration date.
The provided document describes the safety and effectiveness of Bausch & Lomb ReNu MultiPlus™ Lubricating & Rewetting Drops, an in-eye soft contact lens solution. Since this is a medical device (a lubricating/rewetting drop for contact lenses) and not an AI/ML device, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone AI performance, sample size for training set, and how ground truth for training set was established) are not applicable.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from FDA Guidance and Predicate Equivalence) | Reported Device Performance |
|---|---|
| Safety: Non-toxic to ocular tissue, no significant adverse events, no significant differences in slit lamp evaluations or physiological response compared to predicate. | Demonstrated as non-toxic to ocular tissue in in-vivo preclinical testing. No adverse events reported in clinical study. No significant differences between Test and Control regimens for slit lamp evaluations or physiological response. |
| Effectiveness (Lubricating & Rewetting): Efficacy in lubricating and rewetting soft (hydrophilic) contact lenses during wear, comparable to predicate. | Demonstrated efficacy for lubricating and rewetting soft (hydrophilic) contact lenses during wear. No significant differences between Test and Control Groups with respect to patient symptoms, visual acuity, and average daily wear times. |
| Substantial Equivalence: Physical, chemical, and microbiological properties, indications for use, safety, and effectiveness substantially equivalent to predicate devices. | Physical, chemical, and microbiological properties substantially equivalent to predicate devices (ReNu Lubricating & Rewetting Drops and Sterile Lens Lubricant). Indications for use, safety, and effectiveness also found substantially equivalent. |
| Compatibility with Contact Lenses: Demonstrated compatibility with soft (hydrophilic) contact lenses. | In-vitro lens compatibility testing conducted, establishing product compatibility with soft (hydrophilic) contact lenses. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 87 subjects (174 eyes) successfully completed the clinical study. 59 subjects (93.7%) were in the Test Group (ReNu MultiPlus™) and 28 subjects (90.3%) were in the Control Group (predicate device, ReNu Lubricating & Rewetting Drops).
- Data Provenance: The document does not explicitly state the country of origin, but it is a submission to the US FDA for a product by Bausch & Lomb Incorporated in Rochester, New York. The study was likely conducted in the USA or under US clinical trial guidelines. The study was prospective as it was a clinical evaluation conducted to demonstrate safety and efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the study involves a medical device (contact lens solution) and not an AI/ML diagnostic system requiring expert interpretation for ground truth. The "ground truth" here is derived from clinical observations, patient-reported symptoms, and physiological measurements assessed by clinical investigators. The document does not specify the number or qualifications of the clinical investigators, beyond stating a "one (1) month study was conducted to clinically evaluate the safety and efficacy."
4. Adjudication method for the test set
- This is not applicable for this type of medical device study. Data was collected via slit lamp evaluations, patient symptom reports, physiological responses, visual acuity checks, and wear times. Adverse events were also monitored. A formal adjudication method in the context of expert review for AI/ML ground truth 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 is not applicable as the study is for a contact lens care product, not an AI/ML diagnostic device, and does not involve "human readers" or "AI assistance."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a contact lens solution, not an algorithm.
7. The type of ground truth used
- The "ground truth" in this context was established through:
- Clinical Observations: Slit lamp evaluations (physiological response of the eye).
- Patient-Reported Outcomes: Patient symptoms (e.g., comfort, dryness).
- Physiological Measurements: Visual acuity, average daily wear times.
- Adverse Event Monitoring.
8. The sample size for the training set
- This is not applicable as the device is a contact lens solution and does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- This is not applicable.
§ 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.”