(133 days)
The Apioc, sphere/aspheric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.
The Apioc A, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The Apioc P, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myperopia) and presbyopia in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractism not exceeding 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The Apioc AP, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 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 wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The Apioc , Apioc P, Apioc A, and Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lenses are designed with a lenticular zone for attachment to the upper eyelid. The contact lenses are fabricated from (efrofilcon A), 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, (efrofilcon A) is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The material consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the Apioc, Apioc P, Apioc A, and Apioc AP Contact Lens with UV Blocker and center thickness of 0.18mm. a Benzophenone UV absorbing monomer is used to block UV radiation. The UV blocking for lenses averages > 98% in the UVB range of 280nm - 315nm and >70% in the UVA range of 316 -380nm.
The Apioc, Apioc P, Apioc A, and Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lenses will be manufactured in the sphere, aspheric, toric, multifocal, and multifocal toric design configurations.
The provided document is a 510(k) summary for a contact lens device. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain the level of detail requested regarding acceptance criteria and a specific study proving device performance in the context of an AI/ML medical device.
The document is for a physical medical device (contact lenses) and does not involve AI or algorithms that would require test sets, training sets, adjudication, or MRMC studies for performance evaluation in the way a diagnostic or image analysis AI/ML device would. The "performance data" section states that non-clinical testing was performed for stability and manufacturing verification, and "clinical testing is not required" as the clinical performance of the material has been previously demonstrated.
Therefore, I cannot extract the requested information as it is not present in the provided text. The questions about sample sizes for test and training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the type of device described in this 510(k) summary.
§ 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.