(76 days)
The MIERU (etafilcon 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 .75 diopters or less where the astigmatism does not interfere with visual acuity.
The MIERU (etafilcon 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 or less.
The MIERU (etafilcon A) Multifocal 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 are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D.
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 MIERU (etafilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, aspherical multifocal 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 ionic lens material, (etafilcon A) is a co-polymer of 2- hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1 - trimethylol propane trimethacrylate glycol demethacrylate. It consists of 42% etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer contains a UV absorbing compound and is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.3121. The (etafilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the MIERU Contact Lens with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV blocking for MIERU averages > 99% in the UVB range of 280nm - 315nm and 83% in the UVA range of 316 - 380nm.
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 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 fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are: Refractive Index 1.4050 (wet), Light Transmission (clear) greater than 95%, Light Transmission (tinted) greater than 91%, Water Content 58 %, Specific Gravity 1.017 (hydrated), Oxygen Permeability 19.9 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).
Here's a breakdown of the acceptance criteria and study information for the MIERU (etafilcon A) Daily Wear Contact Lens, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
This 510(k) submission doesn't explicitly state "acceptance criteria" in terms of performance metrics like sensitivity or specificity. Instead, the study focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and non-clinical testing. The acceptance criteria are implicitly met if the new device's properties are comparable to or within acceptable ranges of the predicate devices.
Here's a table summarizing the key technological characteristics considered for equivalence:
| Pre-Clinical Equivalency / Device | ClearLab800 (etafilcon A) (New Device) | Frequency 58 (etafilcon A) (Predicate) | AcuVue 2 (etafilcon A) (Predicate) | Igel 55 UV (methafilcon A) (Predicate) | Reported Device Performance (ClearLab800) |
|---|---|---|---|---|---|
| Intended Use | Correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes, myopia/hyperopia. | Correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes, myopia/hyperopia. | Correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes, myopia/hyperopia. | Correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes, myopia/hyperopia. | Matches intended use of predicates |
| Functionality | Acts as a refractive medium to focus light. | Acts as a refractive medium to focus light. | Acts as a refractive medium to focus light. | Acts as a refractive medium to focus light. | Matches functionality of predicates |
| Indications | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens | Matches indications of predicates |
| Production Method | Cast-molded | Cast-molded | Cast-molded | Cast-molded | Cast-molded |
| FDA Group # | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers |
| USAN name | etafilcon A | etafilcon A | etafilcon A | methafilcon A | etafilcon A |
| Water Uptake (%) | 58.0% | 58.0% | 58.0% | 55.0% | 58.0% |
| Oxygen Permeability | 19.9 x 10^-11 (cm²/sec) (ml O²/ml x mm Hg @ 35°C), (revised Fatt method) | 20.2 x 10^-11 (cm²/sec) (ml O²/ml x mm Hg @ 35°C), (revised Fatt method) | 19.9 x 10^-11 (cm²/sec) (ml O²/ml x mm Hg @ 35°C), (revised Fatt method) | 19.6 x 10^-11 (cm²/sec) (ml O²/ml x mm Hg @ 35°C), (revised Fatt method) | 19.9 x 10^-11 (cm²/sec) |
| Specific Gravity | 1.017 | 1.054 | 1.021 | 1.062 | 1.017 |
| UV Blocking (UVB) | Averages > 99% | Not explicitly stated in table | Not explicitly stated in table | Not explicitly stated in table | > 99% |
| UV Blocking (UVA) | 83% | Not explicitly stated in table | Not explicitly stated in table | Not explicitly stated in table | 83% |
Summary of Non-Clinical Performance Data (Used to demonstrate equivalence):
The device underwent the following non-clinical tests as recommended by the Premarket Notification 510(k) guidance document for Daily Wear Contact Lenses, revised May 1994:
- Toxicology testing:
- Cytotoxicity
- USP Ocular Irritation
- USP Systemic Injection
- Leachability / Residual monomer Studies
- Physicochemical property testing
The conclusion drawn from these studies was that the MIERU Soft Contact Lens is substantially equivalent to the predicate devices and does not raise different questions of safety and effectiveness.
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical trials. The data presented for the new device (ClearLab800 etafilcon A) are physical and chemical properties derived from laboratory testing of the device itself.
- Data Provenance: The data refers to the characteristics of the device (ClearLab800 (etafilcon A)) itself, rather than test data from patients. The origin of the raw materials for manufacturing is not specified, nor is there a mention of specific countries for testing. This is a non-clinical submission, not a clinical trial. The data is prospective in the sense that these properties were measured on the newly developed device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A). This submission relies on non-clinical data (physical and chemical properties, toxicology) to demonstrate substantial equivalence to predicate devices, not on expert-adjudicated clinical outcomes for a "ground truth." The "ground truth" here is the established safety and effectiveness of the predicate devices based on their own prior approvals and the standardized methods used for material characterization and toxicology.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. As there's no clinical test set requiring expert adjudication for a diagnosis or outcome, no adjudication method was used.
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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 is not an AI/CAD device. It is a contact lens. Therefore, no MRMC study was performed, and this question is not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The "device performance" in this context refers to the inherent physical and chemical properties of the contact lens itself, measured directly in a laboratory setting, independent of human interaction or a human-in-the-loop scenario. The non-clinical tests (toxicology, leachability, physicochemical properties) are standalone assessments of the device's characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this submission is indirectly established by the legally marketed predicate devices and the objective measurements of the new device's physical, chemical, and biological properties through standardized laboratory testing (e.g., water content, oxygen permeability, specific gravity, toxicology tests). The concept of "ground truth" derived from expert consensus or pathology, as typically used in AI/CAD imaging, does not apply here. The benchmark is the established safety and performance profile of the predicate devices.
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The sample size for the training set:
- Not applicable (N/A). This is a submission for a medical device (contact lens), not an AI algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable (N/A). As stated above, this is not an AI algorithm, so there is no training set or associated ground truth establishment process in that context.
§ 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.