(68 days)
The 59% extreme H2O® (hioxifilcon A) soft contact lens for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The leas may be worn by persons who exhibit refractive astigmatism of .75 Diopters or less that does not interfere with visual acuity. The lens are available clear and with a blue visibility handling tint.
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When presentbed for frequent/planned replacement wear, the lens may be disinfected using either a heat or chemical disinfection system.
The 59% extreme H2O® (hioxifilcon A) soft contact lens are hemispherical shells with molded sphencal base curves and molded from surfaces. The 59% extreme H100 soft contact lens are fabricated from (hioxifilcon A) which is a non-ionic ultra high molecular weight copolymer of 2-hydroxyethy) methacy wate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 41% hioxifilcon A and 59% water by weight when immersed in normal saline solution buttered with either sodium bicarbonate or sodium perborate. The lens is available in clear and with a blue visibility handling tint, phthalocyanato (2) - (copper).
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 physical properties of the lens are:
| PROPERTY | VALUE |
|---|---|
| Refractive Index | 1.515 (dry) |
| 1.404 (hydrated) | |
| Light Transmission: | greater than 95% |
| Water Content | 59% |
| Specific Gravity | 1.308 (dry) |
| 1.136 (hydrated) | |
| Oxygen Permeability | |
| (Dk Value) | 18 X 10-11 Fatt Units |
| (cm²/sec)(ml O₂/ml x mm Hg @ | |
| 35°C), revised Fatt method |
The provided text is a 510(k) summary for a contact lens, focusing on a manufacturing process change rather than the development of an AI/ML device. Therefore, the questions related to AI/ML device performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable.
However, I can extract information related to the device's acceptance criteria and the study that proves it meets those criteria, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the requirement for "substantial equivalence" to the predicate device, specifically regarding physical, chemical, optical, and toxicological performance. The "reported device performance" are the values for the "cast-molded" lens which were found to be equivalent to the "lathe-cut" predicate.
| Property | Acceptance Criteria (Equivalent to Lathe-Cut Predicate) | Reported Device Performance (Cast-Molded) |
|---|---|---|
| Refractive Index | Equivalent to predicate | 1.515 (dry) / 1.404 (hydrated) |
| Light Transmission: | Equivalent to predicate | greater than 95% |
| Water Content | Equivalent to predicate | 59% |
| Specific Gravity | Equivalent to predicate | 1.308 (dry) / 1.136 (hydrated) |
| Oxygen Permeability (Dk Value) | Equivalent to predicate | 18 X 10-11 Fatt Units (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), revised Fatt method |
| Toxicological Profile | Equivalent to predicate | Equivalent to predicate |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the "side by side comparison test results." It also does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device requiring expert ground truth for classification. The "ground truth" for this device's performance is based on direct physical, chemical, and optical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device. The comparison of physical and chemical properties would involve standard laboratory testing and measurements, not expert adjudication.
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. This is a contact lens, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for establishing equivalence was the measured physical, chemical, and optical properties of the original "lathe-cut" 59% extreme H2O® contact lens. The "cast-molded" version was compared directly to these established properties.
8. The sample size for the training set
Not applicable. This is a contact lens undergoing a manufacturing process change, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a contact lens undergoing a manufacturing process change, not an AI/ML model that requires a training set.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "Side by side comparison test results." This study demonstrated that "the physical/chemical/optical and toxicological performance characteristics of the cast-molded contact lens are equivalent to the lathe-cut predicate device contact lens."
The core of the study was a direct comparison of the new "cast-molded" lens to the previously cleared "lathe-cut" lens across various specified properties (Refractive Index, Light Transmission, Water Content, Specific Gravity, Oxygen Permeability, and Toxicological Profile). The acceptance criterion was that the performance of the cast-molded lens should be equivalent to that of the lathe-cut predicate device. The document states that this equivalence was achieved, leading to the FDA's determination of substantial equivalence.
§ 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.