(265 days)
The AQUASOFT ALL-DAY (hioxifilcon A) Spherical 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. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.
The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The AQUASOFT ALL-DAY T (hioxifilcon A) Toric 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 may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Eyecare practitioners may prescribe the lenses for 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.
The AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, and as a back surface astigmatic (toric) lens. 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, (hioxifilcon A) is a random copolymer of 2-hydroxythyl methacrylate and 2,3 -dihydroxypropyl methacrylate, cross linked with ethylene glycol dimethacrylate. It consists of 43% hioxifilcon A and 57% water by weight when immersed in sodium carbonate buffered saline solution. The lens is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.2121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name.
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 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 appear somewhat warped however, 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 57% water by weight.
This 510(k) summary describes a new contact lens device, the AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Daily Wear Contact Lens, and compares it to predicate devices to establish substantial equivalence. The document primarily focuses on demonstrating that the new device shares similar technological characteristics and intended use with existing legally marketed devices.
However, it does not contain information related to a study proving the device meets specific acceptance criteria in the way described by the user's detailed request. The 510(k) summary is for a medical device (contact lens), and its demonstration of safety and effectiveness typically relies on comparing its physical and chemical properties and intended use to predicate devices, rather than a clinical study with performance metrics in the context of AI/diagnostic devices.
Therefore, many of the requested fields cannot be filled from the provided text.
Based on the provided text, here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document provides a comparison of technological characteristics between the new device and predicate devices. These characteristics serve as the basis for establishing substantial equivalence, indicating that the new device performs similarly to the predicates. While not explicitly "acceptance criteria" in a traditional diagnostic study sense, these are the properties that must be substantially equivalent.
| Characteristic | Acceptance Criteria (Implied by Predicates) | Reported Device Performance (AQUASOFT ALL-DAY & ALL-DAY T) |
|---|---|---|
| Intended Use | Correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia for daily wear. | Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. |
| Functionality | Contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina. | The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina. |
| Indications | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens |
| Production Method | Cast-molded or Lathe-Cut (predicates include both) | Cast-molded |
| FDA Group # | Group # 2 (>50% Water, non-ionic Polymer) or Group # 4 (>50% Water, ionic Polymer) | Group # 2 (>50% Water, non-ionic Polymer) |
| USAN name | hioxifilcon A or etafilcon A | hioxifilcon A |
| Water Uptake (%) | ~58.0% - 61.2% (range of predicates) | 57.0% |
| Oxygen Permeability (Dk) | ~19.9 - 20.5 x 10^-11 (range of predicates) | 20.0 x 10^-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (Fatt method, ISO 9913-1). |
| Specific Gravity | ~1.017 - 1.118 (for the two predicates with data) | 1.129 |
Regarding the study that proves the device meets the acceptance criteria:
The document describes a 510(k) submission, which relies on demonstrating substantial equivalence to legally marketed predicate devices. This is not a study in the sense of a clinical trial designed to measure performance against a specific set of acceptance criteria for diagnostic output or treatment efficacy. Instead, it's a submission of data (physical properties, chemical composition, intended use, manufacturing method) that shows the new device is as safe and effective as a predicate device.
Specifically, the "study" mentioned is the comparison of the new device's technological characteristics to those of three predicate devices. This comparison (Table #1) is the core evidence presented.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not provided. This type of information is typically not included in a 510(k) submission for a contact lens, as it's not a diagnostic device with a "test set" of patient data for performance evaluation in the requested manner. The "data" here refers to the device's physical and chemical properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This concept of "ground truth" and expert adjudication is relevant for diagnostic devices or AI algorithms evaluating medical images/data, not for the physical properties of a contact lens.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. The device is a contact lens, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The device is a contact lens, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable/Not provided. The "ground truth" for a contact lens's performance is its physical and chemical properties and its ability to correct vision, which is evaluated through refractive measurements and observation during eye care professional fittings, not through pathology or outcomes data in the context of a diagnostic test.
8. The sample size for the training set:
- Not applicable/Not provided. There is no "training set" in the context of a contact lens 510(k) submission.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
§ 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.