(113 days)
The AVT NATURASOFT, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. 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 AVT NATURASOFT, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.
The AVT NATURASOFT, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic requiring add power of up to +4.00 diopters.
The AVT NATURASOFT, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The AVT NATURASOFT, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners are to prescribe the lenses for quarterly 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 or hydrogen peroxide disinfection systems.
The AVT NATURASOFT Silicone Hydrogel Soft 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 a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a 0.9% saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eve covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
- Table of acceptance criteria and reported device performance:
The document doesn't provide specific acceptance criteria values in a table. Instead, it states that the non-clinical testing demonstrates:
- Lenses supplied in glass vials are sterile for the indicated shelf-life.
- The packaging material and extracts are not toxic and not irritating.
- Lens physical and material properties are consistent with currently marketed lenses.
The reported device performance consists of its physical properties:
| Property | Value |
|---|---|
| Refractive Index | 1.38 |
| Light Transmission | greater than 97% |
| Surface Character | hydrophilic |
| Water Content | 74 % |
| Specific Gravity | 1.048 (hydrated) |
| Oxygen Permeability | 59.8 x 10-11 (cm2/sec) (ml O2/ml x hPa @ 35°C), (revised Fatt method) |
- Sample size used for the test set and data provenance:
The document states that "A series of in vivo preclinical toxicology and biocompatibility tests were performed". However, it does not specify the sample size for these tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.
- Number of experts used to establish the ground truth for the test set and their qualifications:
The document does not mention the use of experts for establishing ground truth for the test set, as no specific clinical outcome data is presented as a test set for expert review. The device's safety and effectiveness were established through non-clinical testing and substantial equivalence to a predicate device, rather than a clinical study requiring expert ground truth establishment in a traditional sense.
- Adjudication method for the test set:
Not applicable, as no human-reviewed test set is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a contact lens, not an AI-assisted diagnostic device, so an MRMC study is not relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a medical device (contact lens) and not an algorithm.
- The type of ground truth used:
The "ground truth" for the non-clinical testing involved established scientific protocols and GLP regulations. For the claim of substantial equivalence, the predicates' established safety and effectiveness data served as an indirect form of "ground truth".
- The sample size for the training set:
Not applicable, as this is a contact lens and not a machine learning algorithm.
- How the ground truth for the training set was established:
Not applicable, as this is a contact lens and not a machine learning algorithm.
§ 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.