(29 days)
OCuSOFT® AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
OCuSOFT® AMENITY™ (linofilcon A) TORIC DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.
OCuSOFT® AMENITY™ (linofilcon A) MULTIFOCAL DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are a hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution with added lubricants. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ contain C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling.
The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >70% in the UVA range (316nm - 380nm).
The provided text is a 510(k) summary for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™. It details the similarity of the device to predicate devices rather than providing a standalone clinical study with specific acceptance criteria and performance results for the new device.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment for a standalone study is not explicitly present in the provided document. The document refers back to predicate device studies (K213216, K191929, K213119) for clinical and non-clinical data.
However, I can extract the material properties and their tolerances which act as performance criteria for the device itself.
Acceptance Criteria and Reported Device Performance
The provided document lists material properties and tolerances (acting as acceptance criteria) for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™. Since this is a 510(k) summary demonstrating substantial equivalence to predicate devices, the performance is generally asserted to meet these specified ranges, implying the device does meet these criteria. The table below presents these:
| Parameter | Acceptance Criteria (Range/Tolerance) | Reported Device Performance (Implied adherence to these ranges) |
|---|---|---|
| Chord Diameter | 13.00 mm to 15.00 mm, ±0.20 mm | Meets specified range |
| Center Thickness | 0.080 mm @ -3.00 D; When ≤ 0.10 mm → ±0.010 mm + 10%; When > 0.10 mm → ±0.015 mm + 5% | Meets specified range |
| Base Curve | 8.00 mm to 9.50 mm, ±0.20 mm | Meets specified range |
| Back Vertex Power (F'v) | +20.00D to -20.00D; When 0.00 1.50 D→± 5° | Meets specified range |
| Multifocal Power | +0.25 D to +4.00 D (in 0.25 D steps), ±0.25D | Meets specified range |
| Surface Appearance | Lenses should be clear with no surface defect | Meets specified criterion |
| Oxygen Permeability (x 10-11(cm²/sec)(mlO2)/(ml x mmHg)) | 100, ±20% | Meets specified range (100 edge-corrected) |
| Light Transmittance - Tinted (@ 380-780nm) | 95%, ±5% | Meets specified range (implied to be ≥ 95%) |
| Ultraviolet Radiation Transmittance |
§ 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.