(190 days)
The IntelliWave1, Sphere (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased 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 IntelliWave1, Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.
The IntelliWave1, Multifocal (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave1, Multifocal Toric (Acofilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The IntelliWave2, Sphere (Hioxifilcon B) Soft Contact Lenses for daily, wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased 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 IntelliWave2, Toric (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters.
The IntelliWave2, Multifocal (Hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity and are presbyopic requiring add power of up to +4.00 diopters.
The IntelliWave2, Multifocal Toric (Ilioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lons may be cleaned and disinfected using a chemical (not heat) lens care system.
The IntelliWave1, Soft Daily Wear Contact Lenses are fabricated from (Acofilcon B), which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this matcrial allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (acofilcon B) is a terpolymer based on high purity Giycerol Methacrylate 2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methy] methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4' 21 CFR part 73.2121.
The IntelliWave2, Soft Daily Wear 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 copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 51% hioxifilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium tetraborate. The lens material is available clear and with a blue visibility handling tint, phthalocyanato (2) - (copper).
The provided text is a 510(k) Summary for contact lenses and does not describe a study that uses acceptance criteria and reports device performance in the way typically seen for AI/ML devices or diagnostic tools. Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices.
Therefore, many of the requested points related to a study, ground truth, expert review, and AI performance metrics are not applicable here.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" and "reported device performance" in this 510(k) summary is centered on demonstrating that the new devices (IntelliWave1 and IntelliWave2 contact lenses) are substantially equivalent to their predicate devices. The acceptance criteria for substantial equivalence are met when the new devices have the "same as predicate device" characteristics across several key attributes.
Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Implied: "Same as Predicate") | IntelliWave1 Reported Performance | IntelliWave2 Reported Performance | Predicate (Contaflex GM3 49%) | Predicate (BENZ-G3X) |
|---|---|---|---|---|---|
| Intended Use | Same as predicate device | Same | Same | Specified for daily wear, correction of visual acuity in aphakic and non-aphakic persons | Specified for daily wear, correction of visual acuity in aphakic and non-aphakic persons |
| Functionality | Same as predicate device | Same | Same | Acts as a refractive medium | Acts as a refractive medium |
| Indications | Same as predicate device | Daily wear, Soft (hydrophilic) | Daily wear, Soft (hydrophilic) | Daily wear, Soft (hydrophilic) | Daily wear, Soft (hydrophilic) |
| Production Method | Same as predicate device | Lathe-cut | Lathe-cut | Lathe-cut | Lathe-cut |
| FDA Group # | Same as predicate device | 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.