(123 days)
The CONTAFLEX 54 (hioxifilcon D) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (nyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.
The CONTAFLEX 49 (hioxifilcon B) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The CONTAFLEX 54 Spherical Soft (hydrophilic) Contact Lenses are fabricated from hioxifilcon D, 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.
The non-ionic lens material, (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2.3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).
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 (hioxifilcon D) soft hydrophilic contact lens has a spherical back 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 hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are:
Refractive Index 1.5193 (hydrated)
Light Transmission (clear) greater than 96%
Light Transmission (tinted) greater than 96%
Water Content 54 % ± 2%
Specific Gravity (wet) 1.120
Oxygen Permeability 20.96 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃), (revised Fatt method).
The CONTAFLEX 49 Spherical Soft (hydrophilic)Contact Lenses are fabricated from hioxifilcon B, 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.
The non-ionic lens material, (hioxifilcon B) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 51% hioxifilcon B and 49% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint. [phthalocvaninato (2-)] copper. The hioxifilcon B name has been adopted by the United States Adopted Names Council (USAN).
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 (hioxifilcon B) soft hydrophilic contact lens has a spherical back 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 hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:
Refractive Index 1.5164 (hydrated)
Light Transmission (clear) greater than 96%
Light Transmission (tinted) greater than 96%
Water Content 49% ± 2%
Specific Gravity (wet) 1.140
Oxygen Permeability 16.09 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃), (revised Fatt method).
This prompt is asking for a structured summary of acceptance criteria and device performance based on the provided FDA 510(k) submission document for Contaflex contact lenses. However, the document provided is a 510(k) Summary and Determination Letter, not a study report. As such, it does not contain the detailed information required to answer all parts of your request, particularly regarding specific study designs, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case (MRMC) studies.
The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of physical properties and toxicology, rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way you've outlined for an AI/diagnostic device.
Here's an attempt to extract the information that is available and explain what is missing:
1. A table of acceptance criteria and the reported device performance
For medical devices, especially contact lenses in a 510(k) submission, "acceptance criteria" are often tied to demonstrating that the device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness. The performance is demonstrated by comparing the new device's characteristics to those of the predicate.
Below is a table constructed from the "Substantial Equivalence Matrix" (Page 8), showing the comparison of the subject devices (Contaflex 54 and 49) with their respective predicate devices (BENZ-G 4X and BENZ-G 3X). The acceptance criteria, implicitly, are that the subject devices' properties are comparable to or fall within an acceptable range of the predicate devices.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Contaflex 54 - Subject Device) | Reported Device Performance (Contaflex 49 - Subject Device) |
|---|---|---|---|
| Intended Use | Correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia for daily wear. | Matches predicate (correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia for daily wear). | Matches predicate (correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia for daily wear). |
| Functionality | Refractive medium focusing light rays from near and distant objects on the retina. | Matches predicate (refractive medium focusing light rays from near and distant objects on the retina). | Matches predicate (refractive medium focusing light rays from near and distant objects on the retina). |
| Indications | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) | Matches predicate (Soft (hydrophilic) Contact Lens (21 CFR 886.5925)). | Matches predicate (Soft (hydrophilic) Contact Lens (21 CFR 886.5925)). |
| Production Method | Lathe cut | Lathe cut | Lathe cut |
| USAN Name | hioxifilcon D (for BENZ-G 4X) / hioxifilcon B (for BENZ-G 3X) | hioxifilcon D | hioxifilcon B |
| Water Content (%) | 54 ± 2% (for BENZ-G 4X) / 49 ± 2% (for BENZ-G 3X) | 54 ± 2% | 49 ± 2% |
| Oxygen Permeability | $20.09 \times 10^{-11} (cm^2/sec)(mlO_2)/(ml \times mmHg @ 35°C)$ (for BENZ-G 4X) / $15.71 \times 10^{-11}$ (for BENZ-G 3X) | $20.96 \times 10^{-11} (cm^2/sec)(mlO_2)/(ml \times mmHg @ 35°C)$ | $16.09 \times 10^{-11} (cm^2/sec)(mlO_2)/(ml \times mmHg @ 35°C)$ |
| FDA Group | FDA Group 2 (>50% H2O, non-ionic polymer) (for BENZ-G 4X) / FDA Group 1 (50% H2O, non-ionic polymer) | FDA Group 1 ( |
§ 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.