(63 days)
The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eves that are revopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 0.75 diopters (D) or less that does not interfere with visual acuity.
The lenses indicated are for Daily Wear (for available powers see Lens Description Section). Eve care practitioner may prescribe the lens for either single-use disposable daily wear or for frequent replacement wear for daily use, with cleaning, rinsing, disinfection and scheduled replacement from one to 14 days of use. (See Wear Schedule Section for additional information.) When prescribed for frequent replacement wear, the lens must be disinfected using either chemical or heat disinfection systems.
The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are hemispherical shells of the following dimensions:
Chord Diameter: 12.0 to 15.0 mm
Center Thickness: 0.08 to 0.56 mm (Varies with power)
Base Curves: 7.80 to 9.00 mm
Powers: -20.00 Diopters to +20.00 Diopters
The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethy) methylcrylate and 2ethoxyethyl methacrylate. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are made by modifying the clear lens by affixing a colored pigment on that portion of the front surface of the lens which corresponds to the iris. The colored pigments consist of the following color additives listed in the Color Additive Provisions of the Code of Federal Requilations 21 CFR Section 706. All colored lenses contain iron oxides, titanium dioxide and [phthalocyaninato (2-1)] copper. In addition, the green lens contains chromium oxide and the violet lens contains carbazole violet. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are available in the following opaque colors: Blue, Green, Hazel and Violet. The DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses is tinted green with the color additive, phthalocyanine green for easy visibility for handling.
The physical properties of the lenses are:
Specific Gravity: 1.176
Refractive Index: 1.440
Light Transmittance:
FreshLook LiteTint: 95% minimum
FreshLook Colors: 97% minimum
Surface Characteristics: Hydrophilic
Water Content: 38%
Optical Zone (FreshLook Colors): 5 mm
(FreshLook LiteTint): 5 mm to 9 mm (Varies with power)
Oxygen Transmissibility: Dk/L = 12.9 x 10-9 ml O2 cm@ 35°C sec ml mm Hg
The provided text describes a medical device (contact lenses) and its properties but does not contain any information about acceptance criteria or a study designed to prove the device meets such criteria in the context of an AI/ML algorithm or a comparative effectiveness study involving human readers.
The document is a "Summary of Safety & Effectiveness" for a contact lens submission (K962957), which is a regulatory document for medical devices. It focuses on:
- General Information: Device generic and trade names, manufacturer, contact person, common name.
- Indications for Use: What the contact lenses are for (correcting visual acuity for aphakic/non-aphakic persons with nearsightedness/farsightedness and minor astigmatism).
- Substantial Equivalence: How this device is similar to previously marketed devices, citing physical, optical, and chemical characteristics, and preclinical testing (cytotoxicity, systemic toxicity, ocular irritation).
- Device Description: Physical dimensions, material composition (phemfilcon A), color pigments, and physical properties (specific gravity, refractive index, light transmittance, water content, optical zone, oxygen transmissibility).
- General Use Instructions: Wearing schedules (disposable daily wear or frequent replacement wear).
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance for an AI/ML algorithm, as this document does not discuss such a device or study.
{0}------------------------------------------------
Image /page/0/Picture/13 description: The image shows the Wesley Jessen logo. The logo features the letters "WJ" in a stylized font, with the words "Wesley Jessen" above the letters. Below the logo is the text "A Proud Heritage of Innovation".
OCT 1 1996
4/4
333 E. Howard Avenue Des Plaines, IL 60018-5903 Telephone (847) 294-3000
SUMMARY OF SAFETY & EFFECTIVENESS
General Information
| A. | Device Generic Name: | DuraSoft 2 FreshLook phemfilcon A hydrophilic contact lens |
|---|---|---|
| B. | Device Trade Name: | DuraSoft 2 FreshLook COLORS and FreshLook LiteTint Contact Lenses |
| C. | Manufacturer's Name: | Wesley-Jessen Corporation333 East Howard AvenueDes Plaines, IL 60018 |
| D. | Contact Person: | Mr. Richard MainRegulatory AffairsPhone: (847) 294-3342Fax: (847) 294-3110 |
| E. | Device Common Name: | contact lens for daily wear |
Indications for Use
The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eves that are revopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 0.75 diopters (D) or less that does not interfere with visual acuity.
The lenses indicated are for Daily Wear (for available powers see Lens Description Section). Eve care practitioner may prescribe the lens for either single-use disposable daily wear or for frequent replacement wear for daily use, with cleaning, rinsing, disinfection and scheduled replacement from one to 14 days of use. (See Wear Schedule Section for additional information.) When prescribed for frequent replacement wear, the lens must be disinfected using either chemical or heat disinfection systems.
Substantial Equivalence
DuraSoft 2 FreshLook Colors and DuraSoft 2 FreshLook LiteTint Soft (hydrophilic) Contact Lenses are substantially equivalent to other Durasoft 2 clear and tinted lathe cut soft (hydrophillic) contact lenses previously marketed in the United States, Additionally, the subject contact lenses have the same characteristics and properties as the DuraSoft 2 clear and tinted lenses, as approved under NDA N17-852. The DuraSoft 2 FreshLook Colors and FrashLook LiteTint Contact Lenses (the subject lens) is manufactured using the identical manufacturing process as the DuraSoft 3 FreshLook Colors and LiteTint Contact Lenses, as approved under PMA P830037/S33 approved
{1}------------------------------------------------
January 31, 1994. In 1994 the FDA reclassified all daily wear soft (hydrophilic) contact lenses from Class III. Premarket Approval to Class II, Premarket notification. Class for establishing devices as substantially equivalent to previously marketed devices of the same class. DuraSoft 2 FreshLook Colors and DuraSoft 2 FreshLook LiteTint Soft (hydrophilic) Contact Lenses have the same physical, optical and chemical characteristics of their predicate devices. Preclinical testing including testing for cytotoxicity using the agarose overlay method; systemic toxicity in mice; and a primary ocular irritation study in the rabbit have established that minor changes in formulation to enhance molding characteristics have no detrimental affect on the lens material as manufactured.
Device Description
The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are hemispherical shells of the following dimensions:
| Chord Diameter: | 12.0 to 15.0 mm |
|---|---|
| Center Thickness: | 0.08 to 0.56 mm (Varies with power) |
| Base Curves: | 7.80 to 9.00 mm |
| Powers: | -20.00 Diopters to +20.00 Diopters |
The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethy) methylcrylate and 2ethoxyethyl methacrylate. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are made by modifying the clear lens by affixing a colored pigment on that portion of the front surface of the lens which corresponds to the iris. The colored pigments consist of the following color additives listed in the Color Additive Provisions of the Code of Federal Requilations 21 CFR Section 706. All colored lenses contain iron oxides, titanium dioxide and [phthalocyaninato (2-1)] copper. In addition, the green lens contains chromium oxide and the violet lens contains carbazole violet. The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses are available in the following opaque colors: Blue, Green, Hazel and Violet. The DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses is tinted green with the color additive, phthalocyanine green for easy visibility for handling.
The physical properties of the lenses are:
| Specific Gravity: | 1.176 |
|---|---|
| Refractive Index: | 1.440 |
| Light Transmittance: | |
| FreshLook LiteTint: | 95% minimum |
| FreshLook Colors: | 97% minimum |
| Surface Characteristics: | Hydrophilic |
| Water Content: | 38% |
| Optical Zone (FreshLook Colors): | 5 mm |
| (FreshLook LiteTint): | 5 mm to 9 mm (Varies with power) |
| Oxygen Transmissibility: | Dk/L = 12.9 x 10-9 ml O2 cm@ 35°Csec ml mm Hg |
General Use Instructions
The DuraSoft 2 FreshLook Colors (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 2 FreshLook LiteTint (phemfilcon A) Soft (hydrophilic) Contact Lenses are available as Spherical Contact Lenses. The lens wearing schedule may be prescribed for either Disposable Daily Wear or Frequent Replacement Wear for daily use.
ew
{2}------------------------------------------------
In the Disposable program, patients should be instructed to dispose of the lenses at each daily removal and to use lens care products only on an emergency basis.
In the Frequent Replacement Program, the lens wearing time prescribed by the eye care practitioner is for daily wear from 1 to 14 days. Each time the lens needs to be removed before the replacement time has elapsed, the lens must be cleaned, rinsed, and disinfected prior to placing it back on the eye. Wesley-Jessen recommends that the lens be discarded and replaced with a new lens every 2 weeks, or as recommended by the eye care practitioner. The eye care practitioner is encouraged to determine the wearing schedule based on the response of the patient.
§ 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.