(87 days)
The BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
The BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidinone, and is 59% water by weight when immersed in a sterile saline solution. This lens is tinted blue with Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl) phenylamino] anthraquinone). The color additive conforms with 21 CFR Part 73.3106. The lens may also be supplied clear (no tint).
The physical / optical properties of the lens are:
Specific Gravity: 1.119
Refractive Index: 1.4036
Light Transmittance: C.I.E. Y value - at least 97%
Water Content: 59%
Oxygen Permeability (Dk): 22 x 10-11 [cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C (Polarographic Method)
The BAUSCH & LOMB 2-Week (hilafilcon B) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
• Diameter: 13.5mm to 15.0mm
• Center Thickness: 0.05mm to 0.75mm
• Base Curve: 7.8mm to 9.5mm
• Powers (Spherical): +20.00D to -20.00D
• Toric (Cylinder): 0 to 10 diopters
• Toric Axis: 0° to 180°
Each BAUSCH & LOMB 2-Week (hilafilcon B) Visibility Tinted Contact Lens is supplied in a plastic blister container with a saline solution. The container is marked with the manufacturing lot number of the lens, the base curve, sphere power, diameter and expiration date.
The BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens was evaluated through a one-month, randomized clinical study to demonstrate its safety and efficacy compared to a predicate device, the Bausch & Lomb SofLens one day™ Contact Lens. The study aimed to establish statistical equivalence between the two lenses for both safety and efficacy endpoints.
1. Table of Acceptance Criteria and Reported Device Performance
| Endpoint/Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety: Proportion of total grade 2 or greater positive slit lamp findings (Any Finding) | Statistical equivalence between Test and Control lenses. (Comparison of proportion of findings.) | "There were no significant differences in the proportion of total grade 2 or greater slit lamp findings, for the category of Any Finding, between the Test and Control lenses (all p-values > 0.05). Therefore, the safety end-point defined in the protocol was achieved." |
| Efficacy: Proportion of lens visual acuities at the level of 20/40 or better | Statistical equivalence between Test and Control lenses. (Comparison of proportion of visual acuities.) | "There were no significant differences in the proportion of lens visual acuities at the level of 20/40 or better between the Test and Control lenses (all p-values > 0.05). Therefore, the efficacy end-point defined in the protocol was achieved." |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not explicitly state the exact number of participants in the clinical study. It refers to a "one month, randomized clinical study" comparing the Test and Control lenses.
- Data Provenance: The document does not explicitly state the country of origin. It is a submission to the FDA, suggesting the study was conducted to meet US regulatory requirements, which often involve data from within the US or studies designed to be acceptable for US submissions. The study was prospective in nature, as it was a "one month, randomized clinical study" designed to evaluate the safety and efficacy of the device.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study. Slit lamp findings and visual acuity measurements are typically obtained by trained ophthalmic professionals (e.g., optometrists, ophthalmologists, or certified technicians).
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The "safety end-point" was based on "the proportion of total grade 2 or greater positive slit lamp findings," and the "efficacy end-point" was based on "the proportion of lens visual acuities at the level of 20/40 or better." This suggests direct measurement and analysis, rather than a consensus-based adjudication process for individual cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This study compares the new device to a predicate device in a single-reader (patient wear) context, not the performance of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was done. This device is a contact lens, meaning its performance is directly related to wear by human subjects. There is no "algorithm only" component to evaluate.
7. Type of Ground Truth Used
The ground truth for the clinical study was based on:
- Clinical Observations/Measurements: Slit lamp findings for safety (clinical signs of ocular irritation or adverse events).
- Objective Clinical Measurements: Visual acuity measurements for efficacy.
8. Sample Size for the Training Set
This product is a physical medical device (contact lens), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical study served as the primary evaluation of the device's performance.
9. How Ground Truth for the Training Set Was Established
As this is not an AI/algorithm-based device, the concept of a "training set" and establishing ground truth for it does not apply. The safety and efficacy of the contact lens were established through the clinical study described, where outcomes were measured directly from patient wear.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.