(106 days)
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses, including silicone hydrogel as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lenses during wear. The product may be used with daily or extended wear, and disposable lenses.
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is a sterile, preservative free, buffered, isotonic, aqueous solution that contains boric acid, sodium borate, potassium chloride, erythritol, poloxamine, glycerol and hyaluronan for lubricating and rewetting soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and rigid gas permeable contact lenses during wear.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The document describes the device, Bausch + Lomb Preservative Free Lubricating and Rewetting Drops, as being substantially equivalent to the predicate device, OPTI-FREE Replenish Rewetting Drops. The "acceptance criteria" are implicitly defined by demonstrating non-inferiority to the predicate device in terms of safety and effectiveness.
Here's a table summarizing the implicit acceptance criteria (non-inferiority to the predicate) and the reported device performance, as evidenced by the clinical study:
| Acceptance Criteria (Implicit: Non-inferiority to Predicate Device) | Reported Device Performance (Bausch + Lomb Preservative Free Lubricating and Rewetting Drops) |
|---|---|
| Safety: | |
| Non-inferiority to predicate for slit lamp findings > Grade 2 | Achieved. The Bausch + Lomb Preservative Free Lubricating and Rewetting Drops group demonstrated non-inferiority to the OPTI-FREE Replenish Rewetting Drops group Over All Follow-up Visits for slit lamp findings greater than Grade 2. |
| Acceptable adverse event profile | Minimal. Five ocular treatment-emergent adverse events (TEAEs) in three eyes of two subjects (eye irritation (2), eye pruritus (2), eye complication associated with ocular discomfort with device (contact lens) (1)). All resolved with no action required. No discontinuations due to AEs. No corneal infiltrates or changes to pre-existing corneal scars. No notable differences in lens wear/performance parameters or visual acuities compared to control. |
| Effectiveness: | |
| Non-inferiority to predicate for overall comfort | Achieved. Treatment differences indicated that the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is non-inferior to the OPTI-FREE Replenish Rewetting Drops solution for overall comfort averaged over all follow-up visits. |
| Non-inferiority to predicate for dryness | Achieved. Treatment differences indicated that the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is non-inferior to the OPTI-FREE Replenish Rewetting Drops solution for dryness averaged over all follow-up visits. |
| Non-inferiority to predicate for optimal (none/light) lens deposits | Achieved. Treatment differences indicated that the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops is non-inferior to the OPTI-FREE Replenish Rewetting Drops solution for optimal (none or light) lens deposits at all follow-up visits. |
| Acceptable performance for additional effectiveness assessments | Achieved. No notable differences between the two treatment groups with regard to additional effectiveness assessments of symptoms/complaints, worn lens characteristics, and dispensed lens characteristics. |
| Compatibility with various lens types | Demonstrated. Compatible with soft contact lenses (including silicone hydrogel), rigid gas permeable, silicone acrylate (SA), and fluorosilicone acrylate (FSA) lenses, as evidenced by lens compatibility studies and inclusion of these lens types in the clinical study. |
Study Details:
2. Sample size used for the test set and the data provenance:
- Sample Size (Clinical Study):
- Enrolled: 369 subjects
- Completed: 365 subjects
- Test Group (Bausch + Lomb Preservative Free): 188 subjects
- Control Group (OPTI-FREE Replenish): 181 subjects
- Data Provenance: The study was a "multicenter, randomized, masked, parallel, bilateral study conducted in the USA." This indicates prospective data collection from multiple sites within the contiguous United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not specify the number of experts used or their qualifications for establishing ground truth for the clinical study's endpoints. The "ground truth" for safety and effectiveness endpoints (e.g., slit lamp findings, comfort, dryness, lens deposits) would typically be assessed by the clinicians (e.g., optometrists or ophthalmologists) participating in the multicenter study.
4. Adjudication method for the test set:
The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). Since it was a "masked" study, assessors were likely blinded to the treatment assignment. The primary endpoints were compared statistically between the two groups. It's implied that the findings from the clinicians at each site contributed to the data for analysis.
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, an MRMC comparative effectiveness study was not done. This study is for contact lens rewetting drops, not an AI-powered diagnostic device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a medical product (rewetting drops) and not an algorithm or AI system.
7. The type of ground truth used:
For the clinical study, the ground truth was based on clinical assessments and subjective patient reporting.
- Clinical Assessments: E.g., slit lamp findings (graded by clinicians).
- Subjective Patient Reporting: E.g., overall comfort and dryness (self-reported by subjects).
- Objective Observations: E.g., lens deposits (likely observed and graded by clinicians).
8. The sample size for the training set:
Not applicable. This is a medical product (rewetting drops), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set for this type of device.
§ 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.”