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510(k) Data Aggregation
(96 days)
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4.
The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing sodium hyaluronate and trehalose wetting agents.
The provided document describes the predicate device "Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear" (K143052) and the new device "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear." The acceptance criteria are based on demonstrating substantial equivalence to the predicate device through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison to the predicate device, serving as the de-facto acceptance criteria. The subject device must match or perform equivalently to the predicate device across various parameters.
| Parameter | Acceptance Criteria (Predicate Device K143052) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | Correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. Lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Helps protect against transmission of harmful UV radiation. Prescribed for single use daily disposable or daily wear in a Frequent Replacement Program, disinfected using chemical or hydrogen peroxide systems. | Correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. Lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Helps protect against transmission of harmful UV radiation. Prescribed for single use daily disposable or daily wear in a Frequent Replacement Program, disinfected using chemical or hydrogen peroxide systems. |
| Material | Polymacon | Polymacon |
| Manufacturing Method | Cast Molded | Cast Molded |
| Water Content | 38 % | 38 % |
| Powers | -0.00 ~ -20.00 D | -0.50 D ~ -20.00 D |
| Light Transmittance | 95 % (± 5 %) | 95 % (± 5 %) |
| UV-A | < 50 % | < 50 % |
| UV-B | < 5 % | < 5 % |
| Refractive Index | 1.440 (± 0.005 nd) | 1.440 (± 0.005 nd) |
| Base Curve | 8.60 (± 0.20 mm) | 7.85 ~ 10.00 (± 0.2 mm) |
| Diameter | 14.00 (± 0.20 mm) | 12.00 ~ 15.00 (± 0.2 mm) |
| Tint | C.I. Reactive Blue #4 for handling purpose and printed with an intermittent coating a combination of the following approved pigments: Copper Phthalocyanine, Reactive Black 5, Iron Oxide, Titanium Dioxide, Carbazole Violet and D&C Yellow No. 10. | C.I. Reactive Blue #4 for handling purpose |
| Packaging Solution | Phosphate buffered saline solution containing sodium hyaluronate and trehalose | Phosphate buffered saline solution containing sodium hyaluronate and trehalose |
| Toxicity (Acute Systemic Injection) | Meets requirements of systemic injection test, non-toxic. | Meets requirements of systemic injection test, non-toxic. |
| Toxicity (White Rabbit Ocular Irritation) | No ocular irritation. | No ocular irritation. |
| Toxicity (Cytotoxicity) | Meets requirements of ISO 10993-5. | Meets requirements of ISO 10993-5. |
| Extractables (Leachability) | Demonstrated equivalence to predicate. | Testing performed, results demonstrated safety and effectiveness equivalent to predicate. |
| Finished Lens Parameters | Demonstrated equivalence to predicate. (Specific parameters like Base Curve and Diameter have differences as noted above, which are considered within acceptable limits for substantial equivalence.) | Testing performed, results demonstrated safety and effectiveness equivalent to predicate. |
| Light Transmittance | Demonstrated equivalence to predicate. | Testing performed, results demonstrated safety and effectiveness equivalent to predicate. (Specific values for UV-A, UV-B, and Light Transmittance are identical to predicate.) |
| Refractive Index | Demonstrated equivalence to predicate. | Testing performed, results demonstrated safety and effectiveness equivalent to predicate. (Specific value identical to predicate.) |
| Water Content | Demonstrated equivalence to predicate. | Testing performed, results demonstrated safety and effectiveness equivalent to predicate. (Specific value identical to predicate.) |
| Shelf-life | Demonstrated equivalence to predicate. | Testing performed, results demonstrated safety and effectiveness equivalent to predicate. |
| Mechanical Properties Comparative Testing | Demonstrated equivalence to predicate. | Testing performed, results demonstrated safety and effectiveness equivalent to predicate. |
| Specific Gravity Comparative Testing | Demonstrated equivalence to predicate. | Testing performed, results demonstrated safety and effectiveness equivalent to predicate. |
| Physical Compatibility Test with Contact Lens Care Solution and Packaging Solution | Demonstrated equivalence to predicate. | Testing performed, results demonstrated safety and effectiveness equivalent to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical trials or data for algorithm evaluation. Instead, it refers to non-clinical testing to demonstrate equivalence. For these non-clinical tests (e.g., toxicity, extractables, finished lens parameters), the sample sizes are not explicitly mentioned.
The data provenance for most tests is implied to be from the manufacturer, Yung Sheng Optical Co., Ltd., based in Taiwan. The tests are described as preclinical testing performed to demonstrate the safety and effectiveness. These are laboratory-based tests rather than data collected from human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The evaluation is based on non-clinical laboratory testing and comparison to an existing predicate device, not on expert-adjudicated images or clinical outcomes requiring ground truth establishment by experts in that manner.
4. Adjudication Method for the Test Set
Not applicable. There's no adjudication process described as the safety and effectiveness are determined by laboratory test results against established compliance standards (e.g., ISO 10993-5) and direct comparison to the predicate device's characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/software device. It is a soft contact lens, and its evaluation does not involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/software device.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and performance characteristics of legally marketed predicate devices, along with compliance with international standards for medical device materials and product characteristics (e.g., ISO 10993-5 for cytotoxicity, FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses). The subject device demonstrates equivalence to these benchmarks through specific laboratory tests.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/software device and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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