(162 days)
Spherical and Aspheric
Ethos Aquell (Hioxifilcon A) Spherical and Aspheric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Toric
Ethos Aquell (Hioxifilcon A) Toric One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.
The lenses are intended for single-use disposable wear.
The Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in spherical, aspherical and toric designs. It is an non-ionic hydrogel lens Hioxifilcon derived from of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (GlycerolMethacrylate, GMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution. one is borate solution (Saline 2); another one is borate solution with sodium hyaluronate (Saline 1). The lens polymer further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121.
This document is a 510(k) summary for a contact lens, not an AI/ML medical device. Therefore, the information typically required for an AI/ML device's acceptance criteria and study proving it meets those criteria (such as sample size for test/training sets, expert consensus, MRMC studies, etc.) is not present.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is the standard pathway for many medical devices, including contact lenses. This involves showing similar technological characteristics and performance through non-clinical testing.
Here's an analysis of the provided text in relation to the requested information, highlighting why certain points cannot be addressed:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table of technological characteristics between the proposed device ("Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)") and a predicate device (K040303). This isn't strictly "acceptance criteria" in the sense of performance metrics for an AI/ML algorithm, but rather a comparison for demonstrating substantial equivalence.
| Characteristic | Proposed Device (Ethos Aquell) | K040303 Predicate |
|---|---|---|
| Production Method | Cast-Molded | Cast-Molded |
| USAN Name | Hioxifilcon A | Hioxifilcon A |
| Material Classification | Group 2 (high water non-ionic) | Group 2 (high water non-ionic) |
| Water Content (%) | 59% | 59% |
| Refractive Index | 1.400 | 1.404 |
| Oxygen Permeability (edge corrected) @ 35°C | 20.6 x 10-11 (cm²/sec)(mlO2/ml-mmHg) | 18 x 10-11 (cm²/sec)(mlO2/ml-mmHg) |
| Transmittance: Visible light @ 380~780nm | > 95% | > 95% |
| Transmittance: UVA @ 380-315nm |
§ 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.