(61 days)
The AL-47 Toric (isofilcon) Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia, hyperopia and possesses refractive astigmatism not exceeding 10 Diopters.
The AL-47 Toric (isofilcon) soft contact lenses are fabricated from isofilcon, 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. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (isofilcon) 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; it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 36% water by weight.
This document doesn't contain a study that demonstrates the device meets acceptance criteria. Instead, it's a 510(k) summary for a medical device (AL-47 Toric contact lens) seeking FDA clearance based on substantial equivalence to previously marketed predicate devices, not on new clinical performance data.
Therefore, most of the information requested about acceptance criteria and a detailed study (like sample sizes, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not present in this document.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence submission, "acceptance criteria" are implied by the characteristics of the predicate devices. The "reported device performance" is presented as equivalence to these predicate characteristics.
| Characteristic | Implied Acceptance Criteria (Predicate Device Range/Value) | AL-47 Toric Performance | Meets Criteria? |
|---|---|---|---|
| Production Method | Lathe-Cut | Lathe-Cut | Yes |
| Lens Function | Refractive medium compensating for refractive error, including astigmatism | Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including (astigmatism) | Yes |
| Material | Hydrophilic Polymer | Hydrophilic Polymer | Yes |
| Water Content | 38%/45% | 36% | Implied Yes (similar enough for equivalence) |
| Polymer Content | 62%/55% | 65% | Implied Yes (similar enough for equivalence) |
| Polymer | polymacon/hefilcon B | isofilcon | Implied Yes (different polymer but deemed equivalent overall) |
| DK Value | 18.8/13.0 | 3.7 | Implied Yes (different DK but deemed equivalent overall) |
| Refractive Index | 1.43 (hydrated) | 1.43 (hydrated) | Yes |
| Specific Gravity | 1.180 (hydrated) | 1.19 (hydrated) | Implied Yes (similar enough for equivalence) |
| FDA polymer group number | Group # 1 (Low 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.