(70 days)
The CONTAFLEX GM3 49 (acofilcon B) 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 .75 diopters or less where the astigmatism does not interfere with visual acuity.
The lens may be disinfected using a chemical disinfecting 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 CONTAFLEX GM3 49% Spherical Soft Contact Lenses are fabricated from acofilcon B, 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.
The non-ionic lens material, (acofilcon B) is a terpolymer based on high purity Glycerol Methacrylate 2.3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2-pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and cross-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lens is available in clear and with a blue visibility-handling tint. Color additive 'Reactive Blue 4' 21 CFR part 73.2121. The acofilcon B name has been adopted by the United States Adopted Names Council (USAN).
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 (acofilcon B) 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 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 filly hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:
Refractive Index: 1.52 (dry) 1.42 (hydrated)
Light Transmission: greater than 96%
Water Content: 49 %
Specific Gravity: 1.142 (hydrated)
Oxygen Permeability: 15.89 X 10-11 (cm2/sec) (ml O₂/ml x hPa @ 35°C), (revised Fatt method).
The provided text describes a 510(k) summary for a soft contact lens and focuses on demonstrating substantial equivalence to predicate devices through pre-clinical testing, rather than reporting on a clinical study with a specific AI-powered device. Therefore, many of the requested categories for AI-specific studies (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable to this document.
Here's the information that can be extracted and a clear indication of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative sense for performance, but rather demonstrates substantial equivalence to predicate devices based on various pre-clinical characteristics. The table below summarizes these characteristics and the reported values for the CONTAFLEX GM3 49% lens and its predicate.
| Pre-Clinical Equivalency / Device | CONTAFLEX GM3 49% (acofilcon B) Reported Performance | BENZ-G3X (hioxifilcon B) Predicate Value |
|---|---|---|
| Intended Use | Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. | Same |
| Functionality | After machining from the optical blank, the contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina. | Same |
| Indications | Daily wear, Soft (hydrophilic) contact lens | Same |
| Production Method | Lathe-cut | Same |
| FDA Group # | Group # 2 >50% Water, Nonionic Polymers | Same |
| USAN name | Acoficon B | Hioxifilcon B |
| Water Content | 48.0% | 48.0% |
| Oxygen Permeability | 15.89 X 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method). | 16.40 X 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method). |
| Specific Gravity | 1.142 | 1.137 |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This document details pre-clinical material testing and solution compatibility, not a clinical study with a "test set" in the context of an AI device.
- Data Provenance: Not applicable for a clinical test set. The data originates from pre-clinical toxicology tests (in-vitro, systemic, acute ocular irritation) and solution compatibility studies performed by Contamac Ltd. or referenced through rights granted to Contamac Ltd. (for shelf life).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" for a test set established by experts in the context of an AI study described here. Pre-clinical material properties are measured objectively.
4. Adjudication method for the test set
- Not applicable. No expert-based adjudication for a test set is described.
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
- No. This document does not mention an MRMC study or any AI component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This document does not describe an algorithm or AI device.
7. The type of ground truth used
- Not applicable in the context of an AI algorithm. For the pre-clinical tests, the "ground truth" is based on objective measurements of material properties (e.g., water content, oxygen permeability, specific gravity, refractive index, light transmission) and biological responses in standardized toxicology assays (e.g., cytotoxicity, systemic toxicity, ocular irritation). Solution compatibility was assessed by comparing initial and final lens parameters after 30 cleaning/conditioning cycles.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" as it's not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set mentioned.
§ 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.