(230 days)
Proclear Multifocal Toric (omaficon B) 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 which, possess astigmatism to -5.75 diopters or less, and are presbyopic.
Proclear Multifocal XR (omafilcon B) 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 and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity.
Proclear Toric XR (omafilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes that are myopic or hyperopic which possess astigmatism corrections to -5.75 diopters.
Proclear Sphere and Asphere: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in non-aphakic persons with non- diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.
Proclear. Toric: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for-the-correction-of-visual-acuity-in-non-aphakic-persons-with-non-diseased-eves-thatare myopic or hyperopic .- The lens may be worn by persons who - have astigmatism of 5.00D or less.
Proclear Multifocal: (omafilcon B) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in non-aphakic persons with non-diseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.
Proclear (omafilcon B) Soft (hydrophilic) Contact 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 eye care practitioners in consultation with their patients.
The Proclear lens is composed of polymer of 2-hydroxy-ethylmethacrylate and 2-metacryloloyoxyethyl phosphorylcholine cross linked with ethylene glycol dimethacrylate. The lenses are tinted blue from edge to edge for visibility purposes. The Proclear (omafilcon B) Soft (hydrophilic) contact lenses are a hemispherical shell. The design and toxicological properties of the devices with the modified formula to increase the water content to 62% are unchanged from predicate 510ks.
Proclear Toric and Proclear Toric XR (omafilcon B) Soft (Hydrophilic) Contact Lenses are back surface toric.
Proclear Multifocal and Proclear Multifocal XR (omafilcon B) Soft(Hydrophilic) Contact Lenses are available as a multifocal lens with an aspherical front surface and spherical back surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The multifocal lens has two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.
Proclear Multifocal Toric (omafilcon B) Soft (Hydrophilic) Contact Lens front surface is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic.
Proclear Sphere and Asphere: (omofilcon B) Soft (hydrophilic) Contact Lenses. The sphere lenses have spherical optical zone and asphere lens have an aspherical optical zone. This aspheric optical zone design (front surface) controls and limits the amount of longitudinal spherical aberration generated by the lens across the power range.
Here's a breakdown of the acceptance criteria and study information for the CooperVision Proclear (omafilcon B) Soft (Hydrophilic) Contact Lenses, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Tested Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Total Extractables, Water Content, Dk, Light Transmission, Refractive Index (per ISO 18369-4:2006 Ophthalmic Optics – Contact Lenses) | Not explicitly stated | Pass |
| Cytotoxicity | No toxicity issues | No toxicity issues |
| Ocular Irritation | No toxicity issues | No toxicity issues |
| Systemic Toxicity | No toxicity issues | No toxicity issues |
Note: The document states that the physicochemical properties were tested and "indicate no significant change" from predicate devices. The acceptance criteria for these tests are implicitly that they meet the standards for contact lens materials as per ISO 18369-4:2006, and that the results are comparable to the predicate devices. The "Pass" result signifies compliance with these implicit criteria.
2. Sample Size Used for the Test Set and Data Provenance
- For Physicochemical Studies: Not explicitly stated. The studies were "conducted by CooperVision following scientific protocols."
- For Biocompatibility Studies: Not explicitly stated. The studies were "conducted by contract laboratories under Good Manufacturing Practice regulations." Data provenance (country of origin) is not mentioned. These studies were retrospective in the sense that they were conducted on already manufactured materials.
- No clinical studies were conducted. Therefore, there is no test set of human subjects or associated data provenance for clinical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as no clinical studies were conducted involving human subjects to establish ground truth for clinical performance.
- For physicochemical and biocompatibility tests, "ground truth" is established by the standardized methods themselves and the expertise of the laboratory personnel performing the tests, though their specific qualifications or numbers are not mentioned.
4. Adjudication Method for the Test Set
- Not applicable as no clinical studies were conducted that would require an adjudication method for human reader/expert review.
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-assisted diagnostic or therapeutic tool. No MRMC comparative effectiveness study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a contact lens. No standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
- For Physicochemical Studies: The ground truth is established by standardized laboratory measurements and accepted scientific principles as defined in ISO 18369-4:2006, compared against pre-defined specifications and predicate device characteristics.
- For Biocompatibility Studies: The ground truth is established by recognized toxicity endpoints and established scientific guidelines for cytotoxicity, ocular irritation, and systemic toxicity, which determine the safety of the material in biological systems.
8. The Sample Size for the Training Set
- Not applicable, as this is not an AI/machine learning device. The concept of a "training set" in this context is irrelevant. For the material properties, the "training" analogous to material science would involve R&D and historical data on similar materials, but no specific "training set" in the computational sense is mentioned.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as this is not an AI/machine learning device and thus has no "training set" in that sense. The specifications for the material and its properties were likely established through R&D, industry standards, and regulatory requirements based on the predicate devices.
§ 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.