(15 days)
The BAUSCH & LOMB Phoenix (hilafilcon A) 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 eves, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The BAUSCH & LOMB Phoenix (hilaffilcon A) Visibility Tinted Contact Lens may be prescribed for Frequent/Planned Replacement Wear. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eve 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 Phoenix (hilafilcon A) 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 70% water by weight when immersed in a sterile saline solution. This lens is tinted blue with either D&C Green #6 or Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl)phenylaminolanthraquinone). The color additives conform with 21 CFR Part 74.3206 and 21 CFR Part 73.3106, respectively. The lens may also be supplied clear (no tint).
The physical / optical properties of the lens are:
Specific Gravity: 1.075
Refractive Index: 1.38
Light Transmittance: C.I.E. Y value - at least 97%
Water Content: 70%
Oxygen Permeability (Dk): 33 x10-11 [cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C(Polarographic Method)
The BAUSCH & LOMB Phoenix (hilafilcon) 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 Phoenix (hilafilcon A) 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.
This 510(k) premarket notification for the BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens does not contain information commonly found in studies used to establish acceptance criteria and prove device performance in the manner requested. This document is a summary of the device's characteristics and its substantial equivalence to a predicate device, rather than a detailed report of clinical trials or performance testing against specific acceptance criteria.
Therefore, much of the requested information cannot be extracted directly from the provided text. However, I can infer some aspects based on the nature of a 510(k) submission for a contact lens.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document speaks about "physicochemical properties" and "established safety profile" being equivalent to the predicate device, but does not explicitly list acceptance criteria in a quantitative sense for the new device, nor does it present detailed performance results from a study conducted on this specific device against those criteria. The physicochemical properties are described as part of the device's specifications, but not as performance measured against a specific acceptance criterion in the context of a clinical study.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety and Effectiveness | The established safety profile (toxicology, physicochemical properties, manufacturing/chemistry) is equivalent to the predicate device. |
| Compatibility with Care Systems | Not explicitly stated as a separate acceptance criterion for the Phoenix lens, but the predicate device was subjected to care system testing (compatibility testing of recommended lens care regimens and clinical performance testing). The Phoenix lens is deemed substantially equivalent based on this. |
| Vision Correction (Spherical Power) | Provides vision correction in powers ranging from +20.00D to -20.00D. (This is a claim and expected performance, not an acceptance criterion from a study). |
| Vision Correction (Astigmatism) | Provides vision correction of refractive astigmatism up to 10.00 diopters. (This is a claim and expected performance, not an acceptance criterion from a study). |
| Disinfection Compatibility | May be disinfected using a chemical disinfection system. (This is a claim, not an acceptance criterion from a study). |
| Physical/Optical Properties (Device Specifications) | Specific Gravity: 1.075 |
| Refractive Index: 1.38 | |
| Light Transmittance: C.I.E. Y value - at least 97% | |
| Water Content: 70% | |
| Oxygen Permeability (Dk): 33 x10-11 [cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C (Polarographic Method) | |
| Dimensions (Device Specifications) | 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° |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided for the BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens. The document states that the predicate device (SofLens™ one day disposable) "included test data from studies in which hilafilcon A visibility tinted contact lenses were subjected to care system testing, specifically 1) Compatibility testing of the lens care regimens recommended for use in the proposed labeling, and 2) Clinical performance testing." However, the details of these predicate device studies (sample size, provenance, retrospective/prospective nature) are not given here. For the Phoenix lens, the primary "proof" is substantial equivalence, not a new clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. This type of detail is typical for diagnostic AI devices, not contact lenses proving substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 type of study is not applicable to a contact lens. MRMC studies are used for diagnostic imaging AI, where human readers (e.g., radiologists) interpret images with and without AI assistance. This device is a contact lens for vision correction, not an AI diagnostic tool.
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 physical medical device (contact lens), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a contact lens seeking substantial equivalence, the "ground truth" for its safety and effectiveness is largely established through physicochemical property testing, toxicology, manufacturing/chemistry data, and clinical performance data from the predicate device. The new device is then shown to have identical technological characteristics and an equivalent safety profile. Outcomes data from clinical performance testing of the predicate device would have been part of its original clearance.
8. The sample size for the training set
This is not applicable. Contact lenses do not involve AI algorithms that require training sets in the computational sense.
9. How the ground truth for the training set was established
This is not applicable.
§ 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.