(23 days)
The Aquaflex 2 Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism up to 1.50 diopters or less in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be disinfected using either a heat or chemical disinfection system.
The Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens is available as a spherical lens. The lens material, tefilcon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate crosslinked with ethylene glycol dimethacrylate. The Aquaflex 2 Contact Lens is a hemispherical shell.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens, structured to address your specific points:
Note: The provided document is a 510(k) summary for a contact lens, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against specific acceptance criteria in a detailed clinical study report. Therefore, some of your requested information, particularly around detailed study methodology (sample sizes, expert qualifications, adjudication, MRMC, training sets), is not present in this type of regulatory submission. The information provided heavily relies on the equivalence to a previously cleared device.
Acceptance Criteria and Device Performance Study for Aquaflex 2 (tefilcon) Soft (hydrophilic) Contact Lens
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for novel performance metrics are not typically presented in this format. Instead, the document asserts equivalence to a predicate device across several key characteristics. The performance of the Aquaflex 2 is described by its physical/optical properties, which are implicitly accepted if they are comparable to the predicate and meet established safety and effectiveness profiles for contact lenses.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Aquaflex 2) |
|---|---|---|
| Physical/Optical Properties | Comparable to predicate device (BayVue polymacon lens) and within established safe ranges for daily wear contact lenses. | Specific Gravity: 1.18 |
| Refractive Index (wet): 1.43 | ||
| Light Transmittance: 98% | ||
| Water Content: 37.5% | ||
| Oxygen Permeability: 8.9 x 10^-11 (cm/sec)(ml O2/ml x mm Hg) @ 21°C (Fatt Method) | ||
| Intended Use | Matching the intended use of the predicate device for daily wear, correction of refractive ametropia (myopia, hyperopia), and astigmatism |
§ 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.