(89 days)
Bausch & Lomb Sensitive Eyes Multi-Purpose Solution is indicated for use in the daily cleaning, dissolving of Sensitive Eyes Enzymatic Cleaner, ReNu 1-Step or the ually cleaning, and ens Cleaning Tablets, rinsing Tablets, rinsing and storage of daily and extended wear soft (hydrophilic) contact lenses and chemical (not heat) disinfection, as recommended by your eye care practitioner.
Bausch & Lomb Sensitive Eyes Multi-Purpose Solution is indicated for use in the daily cleaning, dissolving of enzymatic cleaning tablets, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care provider.
BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution is a multi-purpose solution used in the care of soft (hydrophilic) contact lenses and is indicated for the cleaning, rinsing, disinfection and storage of soft (hydrophilic) contact lenses. It may also be used as a diluent for all BAUSCH & LOMB enzymatic cleaning tablets. The solution is contained in a plastic bottle and consists of a sterile isotonic solution that contains boric acid, edetate disodium, poloxamine, sodium borate and sodium chloride; it is preserved with [Trademark] (alexidine dihydrochloride 4 ppm).
Each plastic bottle is supplied sterile and is labeled with a lot number and expiration date.
This product will be sold in plastic bottles as a sterile solution; each bottle will be marked STERILE and will be identified with a Lot Number and Expiration Date.
This is some information about the device BAUSCH & LOMB" SENSITIVE EYES" MULTI-PURPOSE SOLUTION. I will do my best to extract the requested information.
1. Acceptance Criteria and Reported Device Performance
The submission states that the device is "substantially equivalent" to the predicate device, BAUSCH & LOMB ReNu Multi-Purpose Solution. This implies that the acceptance criteria for the new device were that its performance should be comparable or demonstrate no clinically significant differences from the predicate device across various parameters.
| Acceptance Criteria (Implied: Equivalence to Predicate) | Reported Device Performance (Summary of Findings) |
|---|---|
| Preclinical: Physical, chemical, and microbiological properties equivalent to predicate. | "The results of these studies indicate that the physical, chemical and microbiological properties of the BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution are equivalent to BAUSCH & LOMB ReNu Multi-Purpose Solution." |
| Preclinical: Non-toxic | "The solution is not toxic and extracts of lenses treated with the solution are not toxic when tested in laboratory animals." |
| Clinical: No clinically significant differences in: clinical findings, visual acuity, lens replacement, lens deposits, subject discontinuations, and lens wearing times. | "Analysis of all data from this study showed no clinically significant differences between the Test and Control Groups for clinical findings, visual acuity, lens replacement, lens deposits, discontinued subjects and lens wearing times for the Test and Control groups." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: A total of 154 subjects were enrolled in the clinical study. Of these, 102 were in the Test (BAUSCH & LOMB Sensitive Eyes Multi-Purpose Solution) group and 52 were in the Control (BAUSCH & LOMB ReNu Multi-Purpose Solution) group. There were 98 completed subjects in the Test group and 51 completed subjects in the Control group.
- Data Provenance: The document does not explicitly state the country of origin of the data. The study was a "three (3) month randomized, parallel, double-masked, controlled clinical study," indicating it was a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on specific "experts" used to establish ground truth in the traditional sense (e.g., radiologists reviewing images). The clinical study involved "seven (7) Investigators." It is assumed these investigators, who would be eye care practitioners, collected and evaluated the clinical findings that served as the basis for comparison between the two solutions. Their specific qualifications beyond being "Investigators" are not detailed.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the test set data. The study was a "double-masked" clinical study, which helps mitigate bias in assessment, but it doesn't specify a method for resolving discrepancies if they arose between investigators' observations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focused on comparing the performance of two contact lens solutions in a clinical setting with human subjects, rather than comparing human readers' diagnostic performance with and without AI assistance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable to this document.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone (algorithm only) performance study was not done. The device is a contact lens solution, not an AI algorithm. The studies performed were a combination of preclinical (in-vitro and in-vivo lab tests) and clinical trials involving human subjects using the solution.
7. Type of Ground Truth Used
For the preclinical studies, the ground truth was established through:
- Laboratory test results: Measuring physical, chemical, and microbiological properties.
- Toxicology studies: In-vitro and in-vivo tests in laboratory animals to assess toxicity.
For the clinical study, the ground truth was established through:
- Clinical findings: Observations made by "Investigators" (eye care practitioners) regarding various parameters like visual acuity, lens replacement, lens deposits, and subject health. Subject discontinuations and lens wearing times were also monitored. This can be considered expert clinical assessment/observation.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is not an AI/machine learning device. The preclinical tests and the clinical study are designed to evaluate the safety and effectiveness of the contact lens solution.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no "training set" in the context of an AI algorithm. The methods for establishing the "ground truth" for the overall device evaluation (preclinical and clinical) are described in point 7.
§ 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.”