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510(k) Data Aggregation
(459 days)
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design and indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system each time it is removed and should be discarded per the eye care practitioner's guidance.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the lens is to be discarded after each removal.
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The lenses contain a benzophenone UV-absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light. The lenses are clear or tinted from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4. Each finished lens is supplied in a plastic blister container with A) Standard Saline Solution, or B) Sodium Hyaluronate Packaging Solution, or C) PMB Packaging Solution, or D) Cyanocobalamin Packaging Solution.
This document is a 510(k) Pre-Market Notification for a contact lens, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through novel studies. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable in the way they would be for an AI/ML medical device.
However, I can extract information related to the device's characteristics and the non-clinical tests performed to demonstrate its safety and effectiveness relative to established standards and predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or target performance manner as one might expect for a diagnostic or AI device. Instead, it compares the subject device's characteristics to those of its predicate devices, implying that similarity or equivalence to the predicate's performance across these characteristics is the "acceptance criterion" for substantial equivalence.
| Characteristic | Acceptance Criterion (Implied: Similar to Predicate) | Reported Subject Device Performance | Predicate Device 1 (K150630) Performance | Predicate Device 2 (K211448) Performance |
|---|---|---|---|---|
| Material USAN Name | Polymacon (same as Predicate 1) | Polymacon | Polymacon | Etafilcon A |
| Manufacturing Method | Cast Molded (same as Predicate 1 & 2) | Cast Molded | Same | Same |
| Sterilization | Moist Heat (Steam) in Validated Autoclave (same as Predicate 1 & 2) | Moist Heat (Steam) in Validated Autoclave | Same | Same |
| Packaging | Blister pack (same as Predicate 1 & 2) | Blister pack | Same | Same |
| Water Content | 38 % (same as Predicate 1) | 38 % | 38 % | 58% |
| Tint | C.I. Reactive Blue #4 (same as Predicate 1) | C.I. Reactive Blue #4 | Same | Reactive Blue 19 |
| Packaging Solution | Similar to predicate packaging solutions or established safe solutions. | A) Standard Saline Solution, or B) Sodium Hyaluronate Packaging Solution, or C) PMB Packaging Solution, or D) Cyanocobalamin Packaging Solution. | Phosphate buffered saline solution containing sodium hyaluronate and trehalose. | Sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate, Polyethylene Glycol, and Cyanocobalamin. |
| Base Curve | Range of 7.50 ~ 9.00 mm (similar to Predicate 1, or appropriate for contact lenses) | 7.85 ~ 10.00 mm | 7.50 ~ 9.00 mm | N/A (Predicate 2 provides a wider range of lens types, base curve is not explicitly listed in table for this predicate) |
| Diameter | Range of 12.0 ~ 15.0 mm (similar to Predicate 1) | 12.0 ~ 15.0 mm | Same | N/A (Predicate 2 provides a wider range of lens types, diameter is not explicitly listed in table for this predicate) |
| Center Thickness (Eye Secret 38 UV lens) | 0.04 ~ 0.14 mm (similar to Predicate 1) | 0.06 ~ 0.13 mm | 0.04 ~ 0.14 mm | N/A |
| Center Thickness (Air Light 38 UV lens) | Not explicitly compared but within acceptable range for contact lenses. | 0.03 mm | N/A | N/A |
| Refractive Index | 1.440 ± 0.005 $n_d$ (same as Predicate 1) | 1.440 ± 0.005 $n_d$ | Same | 1.402 $n_d$ |
| Oxygen Permeability (Dk) | 13.5 x 10-11 (cm2/sec)(ml O2/ml x mmHg) (same as Predicate 1) | 13.5 x 10-11 (cm2/sec)(ml O2/ml x mmHg) | Same | 19.73 x 10-11 (cm2/sec)(ml O2/ml x mmHg) |
| Light Transmittance | 95 ± 5 % (similar to Predicate 1 and >95% for Predicate 2) | 95 ± 5 % | Same | > 95% |
| UV-A Transmittance (Eye Secret 38 UV lens) | < 50 % (same as Predicate 1) | < 50 % | Same | Same (for applicable UV-blocking lenses of Predicate 2) |
| UV-A Transmittance (Air Light 38 UV lens) | < 70 % (implied acceptable for UV-blocking lenses) | < 70 % | N/A | N/A |
| UV-B Transmittance (Eye Secret 38 UV lens) | < 5 % (same as Predicate 1) | < 5 % | Same | Same (for applicable UV-blocking lenses of Predicate 2) |
| UV-B Transmittance (Air Light 38 UV lens) | < 40 % (implied acceptable for UV-blocking lenses) | < 40 % | N/A | N/A |
| Powers (Eye Secret 38 UV lens) | -0.50 ~ -20.00 D (similar to Predicate 1 and within typical contact lens range) | -20.00 ~ +20.00 D | -0.50 ~ -20.00 D | -12.00 ~ +6.00 D (for spherical and aspheric lenses of Predicate 2) |
| Powers (Air Light 38 UV lens) | 0.00 ~ -10.00 D (within typical contact lens range) | 0.00 ~ -10.00 D | N/A | N/A |
| Cytotoxicity Test | Pass (non-toxic) | Passed (reported as non-toxic and biocompatible) | N/A (implicitly passed as legally marketed) | N/A (implicitly passed as legally marketed) |
| Ocular Irritation Test | Pass (non-irritating) | Passed | N/A | N/A |
| Acute Systemic Toxicity Test | Pass (non-toxic) | Passed | N/A | N/A |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical testing, meaning these are laboratory-based tests on the device materials and finished products, not human subject trials.
- Sample Size: Not explicitly stated for each specific physical/chemical test (e.g., how many lenses were tested for water content). However, testing was conducted according to ISO standards, which would include appropriate sample sizes for reproducibility and statistical confidence.
- Data Provenance: The tests are performed by the manufacturer, Yung Sheng Optical Co., Ltd. The document does not specify a country of origin for the data beyond that implied by the manufacturer's location (Taiwan). These are prospective tests performed on the subject device to demonstrate its properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For non-clinical tests of contact lens physical and chemical properties, "ground truth" is established by direct measurement using validated scientific methods and instrumentation, often against international standards (e.g., ISO 18369). Expert consensus is not typically used to establish these types of truths.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or assessment of imaging data where expert disagreement might occur. For objective physical and chemical tests, the results are typically quantitative and directly measured.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a contact lens, not an AI-assisted diagnostic or imaging system. The concept of "human readers" improving with AI assistance does not apply.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device (contact lens), not a standalone algorithm.
7. Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is based on:
- Material specifications: The chemical composition of the lens material.
- Physical and optical measurements: Direct measurements of properties like water content, refractive index, light transmittance, oxygen permeability, base curve, diameter, and center thickness, conforming to ISO standards (ISO 18369-3:2017 and ISO 18369-4:2017).
- Biological safety standards: Compliance with ISO 10993 series for toxicology (e.g., cytotoxicity, ocular irritation, acute systemic toxicity).
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that uses a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
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