(90 days)
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency of from Aqueous Tear Deficiency (non-Sjogren's only).
Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic; possess astigmatism of 10.00 diopters or less. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Daily wear replacement schedules may vary from patient and should be decided by the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and time they are removed from the patients' eve and discarded after the recommended wearing period prescribed by the eve care practitioner. The lenses may be disinfected using a chemical disinfection system.
Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lens is a back surface toric. The lenses are made of polymer of 2-hydroxy-ethylmethacrylate and 2-methacryloyloxyethyl phosphoryicholine crosslinked with ethylenedycol dimethacrylate. The lenses are tinted edge for visibility purposes with the color additive Vat Blue 6. Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as astigmatic (toric) lenses with the following dimensions:
- I Chord Diameter: 13.6 to 15.2 mm
- 트 Center Thickness 0.09 mm to 0.65 mm
- Base Curve: 트 8.3 mm to 8.9mm
- 트 Spherical Powers: -20.00 D to +20.00 D
- I Cylinder Powers: -0.75 to -5.00 D
- 지 Axis 1° to 180°
Proclear Multifocal XR (omafilic) Contact Lenses are available as a multifecal lens with an aspherical front surface and scherical back surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The Proclear Multifocal XR is designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength. The Proclear Multifocal XR / D (dominant) has a spherical central zone for the correction of distance vision and an aspherical annular zone for the correction of intermediate and near vision. The Proclear Multifccal XR / N (non-dominant) has a spherical central zone for the correction of near vision and an aspherical annular zone for the mediate and distance vision. The lenses are tinted edge for visibility purposes with the color additive Vat Blue 6.
The lens material, omafilcon A is a copolymer of 2-hydroxy-ethylmethacryloyloxyethyl phosphorycholine crosslinked with ethylenedycol dimethacrylate. The Proclear UltraVue/D and Proclear UltraVue/N (omatilcon A) Soft (Hydrophilic) Contact Lenses are flexible transparent hemispherical shells of the following dimensions:
- Chord Diameter: 트 13.6 to 15.2 mm
- Center Thickness (minus): 0.09 mm to 0. 65 mm
- エ Base Curve: 8.0 mm to 9.3 mm
- 트 Spherical Powers: -20.00 D to +20.00 D
- Add Powers: +1.00 to +4.00 D
- Central Zone Diameter: ■ 2.3 mm to 2.6 mm (Proclear Multifocal XR / D) 1.7 mm to 2.0 mm (Proclear Multifocal XR / N)
Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are made of polymer of 2-hydroxyethylmethacrylate and 2-methacryloyloxycholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge to edge for visibility purposes with the color additive Vat Blue 6.
The front surface of the Proclear Multifocal Toric (omafilic) Contact Lenses is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic. The Proclear Multifocal Toric contact lenses are designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.
The Proclear Multifocal Toric (omafilic) Contact Lenses are available in two versions. The Proclear Multifocal Toric / D with a spherical central zone for the correction of distance vision and an aspherical annular zone for the correction of internediate and near vision. The Proclear Multifocal Toric / N with a spherical central zone for the correction of near vision and an aspherical annular zone for the correction of intermediate and distance vision.
Both lenses are a flexible transparent hemispherical shell of the following dimensions:
- Chord Diameter: 13.6 to 15.2 mm
- Center Thickness (minus): 0.035 mm to 0.96 mm
- Base Curve: 8.3 mm to 8.9mm
- Spherical Powers: -20.00 D to +20.00 D
- Cylinder Powers: -0.75 to -3.00 D
- Add Powers: +1.00 to +4.00
- Central Zone Diameter: 2.3 mm to 2.6 mm (Proclear Multifocal Toric / D) 1.7 mm to 2.0 mm (Proclear Multifocal Toric/ N)
The physical properties of the lenses are:
- Refractive Index at 25º C 1.40
- Light Transmittance >90%
- Water Content 59 %
- Oxygen Permeability* 21.05 x 10-11 *(cm²/sec) (ml O2/ml x mm Hg) at 35°C. as measured by 201T Permeometer connected to a curved Rehder guard ring polarographic cell
The provided document is a 510(k) summary for contact lenses and therefore does not contain information about an AI/ML device study. It outlines the characteristics and intended use of several contact lens products and establishes substantial equivalence to predicate devices based on physical, optical, chemical, and toxicological studies. Clinical data was not required for this submission.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance
- If a standalone algorithm-only performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.