(28 days)
The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.
The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity.
The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.
The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity.
The Ocu-Flex 55 Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.
The lens may be disinfected with chemical (not heat) disinfection system.
The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are fabricated from methafilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The ionic lens material (methafilcon A) is a hydrophilic co-polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate. When fully hydrated in a 0.9% sodium chloride solution, the lens is 55% water by weight. In that fully hydrated state the lens is soft and readily wet by saline and aqueous solution.
The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are available as a spherical, toric, aspheric and toric aspheric design.
The physical properties of the lens are:
Refractive Index 1.4153
Light Transmission greater than 95% T
Specific Gravity 1.090 g/cc
Water Content 55%
Color Pigment Name Phthalocyanine Blue
Oxygen Permeability Dk=18x10-11 @ 35°C
This 510(k) premarket notification is for contact lenses, which are regulated as medical devices. The submission focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics in the way an AI/ML device would. Therefore, many of the requested fields are not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For contact lenses seeking 510(k) clearance via substantial equivalence, the "acceptance criteria" are not reported as specific performance metrics derived from a clinical trial, but rather as demonstrating equivalence in critical characteristics to a predicate device. The "performance" is implicitly deemed acceptable if these characteristics are substantially equivalent.
| Characteristic | Acceptance Criteria (Predicate Device Value) | Reported Device Performance (Ocu-Flex 55) |
|---|---|---|
| Material | Hydrophilic (methafilcon A) | Hydrophilic (methafilcon A) |
| Water Content | 55% | 55% |
| Dk Value | $18 \times 10^{-11}$ @ 35°C | $18 \times 10^{-11}$ @ 35°C |
| Production Method | Lathe-cut | Lathe-cut |
| Lens Function | Refractive medium for vision correction | Refractive medium for vision correction |
| Indication | Correction of refractive ametropia | Correction of refractive ametropia |
| Refractive Index | Not explicitly stated for predicate but stated as "substantially equivalent" | 1.4153 |
| Light Transmission | Not explicitly stated for predicate but stated as "substantially equivalent" | > 95% T |
| Specific Gravity | Not explicitly stated for predicate but stated as "substantially equivalent" | 1.090 g/cc |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" is a comparative analysis demonstrating substantial equivalence to a legally marketed predicate device (Horizon 55). This is explicitly stated: "The following matrix illustrates that the production method, lens function and material of the Ocu-Flex 55... is substantially equivalent to the predicate device. In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of 510(k) submission. There was no "test set" in the context of an AI/ML or a new clinical performance study. The data provenance is a comparison of product specifications and intended use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth in the context of clinical expert consensus for a test set is not relevant for a substantial equivalence submission of a contact lens based on material and design specifications.
4. Adjudication Method for the Test Set
Not applicable.
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
Not applicable. This device is a contact lens, not an AI/ML diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness profile of the predicate device, Horizon 55, and other similar methafilcon A lenses (BENZ - MF). The manufacturer is demonstrating that the Ocu-Flex 55 matches the characteristics that have already been deemed safe and effective by the FDA through the predicate's prior clearance. This includes:
- Manufacturing/Chemistry Data: The production method (lathe-cut), material (methafilcon A), water content, Dk value, refractive index, specific gravity, and light transmission are all compared to the predicate.
- Intended Use Compatibility: The indications for use are aligned with the predicate device.
- Safety Profile: The submission references the established safety profile (pre-clinical toxicology) of BENZ - MF (methafilcon A), noting equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the Ground Truth for the Training Set Was Established
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.