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510(k) Data Aggregation
(162 days)
Plexus Optix, Inc.
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 |
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