(121 days)
The Vexillum (olifilcon B) with Tangible Polymers Spherical Silicone Hydrogel Soft Contact Lenses are daily wear single use soft contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Vexillum (olifilcon B) with Tangible Polymers Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lenses for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The Vexillum (olifilcon B) with Tangible Polymers Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear single use soft contact lenses for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
The Daily Breeze (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lenses are daily wear single use soft contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
The Daily Breeze (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The Daily Breeze (olifilcon B) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
The Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 nm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing Tangible Polymers (coating on the lens surface during sterilization process) with isotonic buffered saline solution.
The Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 316 - 380 mm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing Sodium Hyaluronate and Sodium Alginate with isotonic buffered saline solution.
The provided document discusses the 510(k) premarket notification for two soft contact lenses: Vexillum (olifilcon B) with Tangible Polymers and Daily Breeze (olifilcon B). It asserts substantial equivalence to a predicate device (Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lenses, K160344).
It is important to note that this document does not describe a study involving an AI/Machine Learning device. It pertains to contact lenses and their physical/chemical properties. Therefore, many of the requested criteria (such as sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.
The "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device through non-clinical bench testing and comparisons of material, design, and performance characteristics.
Here's an attempt to answer the applicable parts of your request based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in the format of a typical AI/ML study (e.g., target specificity and sensitivity values). Instead, it demonstrates "substantial equivalence" by comparing various parameters of the new devices (Vexillum and Daily Breeze) against a legally marketed predicate device (Si-Hy, K160344). The acceptance criterion, implicitly, is that the new devices are "substantially equivalent" to the predicate in terms of their intended use, technological characteristics, and performance characteristics, and that any differences do not raise new questions of safety or effectiveness.
Here's a table summarizing the comparison parameters and their reported performance/characteristics, which effectively serve as the "acceptance criteria" for substantial equivalence in this context:
| Category | Acceptance Criteria (Predicate: Si-Hy (olifilcon B) K160344) | Reported Device Performance (Vexillum) | Reported Device Performance (Daily Breeze) | Result of Comparison |
|---|---|---|---|---|
| Applicant | Visco Vision Inc | Visco Vision Inc | Visco Vision Inc | Same |
| Classification | Class II | Class II | Class II | Same |
| Regulation number | 886.5925 | 886.5925 | 886.5925 | Same |
| Product code | LPL, MVN | LPL, MVN | LPL, MVN | Same |
| Intended use | Myopia, Hyperopia, astigmatism, Presbyopia | Myopia, Hyperopia, astigmatism, Presbyopia | Myopia, Hyperopia, astigmatism, Presbyopia | Same |
| Replacement Schedule | Daily Disposable (Single use) | Daily Disposable (Single use) | Daily Disposable (Single use) | Same |
| USAN Name | olifilcon B | olifilcon B | olifilcon B | Same |
| FDA Category (Group) | Group 5C (Nonionic, Water |
§ 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.