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510(k) Data Aggregation
(256 days)
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with nondiseased 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. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Omafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and 2-Methacryloyloxyethyl phosphoryIcholine (MPC) crosslinked with ethylene glycol dimethacrylate (EDGMA), and has 59% water by weight. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. Thus, the lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye. The transmittance characteristics are less than 5 % in the UVB range of 280 nm to 315 nm and less than 50 % in the UVA range of 316 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive Reactive Blue 246.
The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
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 2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butylmethacrylate copolymer (PMB) wetting agent.
This document is a 510(k) Premarket Notification for a soft contact lens, not an AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria for AI models, such as detailed clinical study designs for AI performance, expert adjudication, MRMC studies, and separate training/test sets for AI, is not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical testing performed to demonstrate the safety and effectiveness of the contact lens itself, primarily through physiochemical and toxicology studies, and by demonstrating substantial equivalence to legally marketed predicate devices.
Here's an attempt to answer the questions based on the provided document, interpreting "acceptance criteria" through the lens of contact lens regulatory submission:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a single formal "acceptance criteria" table in the way one might see for an AI model. Instead, acceptance is demonstrated by meeting established specifications for physical, optical, and chemical properties, and by demonstrating biocompatibility. The performance is compared against predicate devices and relevant ISO standards.
| Characteristic | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (Eye Secret 59 UV Aspheric) |
|---|---|---|
| Material/Process | Substantially equivalent to predicate devices (Proclear (omafilcon A) Daily Disposable/Daily Wear Soft Contact Lens (K061948) & Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses (K162223)) in material (Omafilcon A), manufacturing, sterilization, and packaging. | Same material (Omafilcon A), Cast Molded, Moist Heat (Steam) Sterilization, Blister pack packaging. |
| Intended Use | Substantially equivalent to predicate devices. | Similar indications: correction of refractive ametropia (myopia/hyperopia) in aphakic/non-aphakic persons with non-diseased eyes; astigmatism ≤ 2.00 D. |
| Water Content | Within established specifications; comparable to predicates ($60 \pm 2%$ for predicate 1, $59 \pm 2%$ for predicate 2). | $59 \pm 2 %$ |
| Oxygen Permeability (Dk) | Within established specifications; comparable to predicates ($21.00 \pm 20 %$ for predicate 1, $25.68 \pm 20 %$ for predicate 2). | $25 \pm 20 %$ |
| Light Transmittance | Within established specifications; comparable to predicates ($>90%$ for predicate 1, $98%$ for predicate 2). | $95 \pm 5 %$ |
| UV-A Transmittance | < 50% (This is a specific claim for UV blocking) | < 50 % |
| UV-B Transmittance | < 5% (This is a specific claim for UV blocking) | < 5 % |
| Refractive Index | Within established specifications; comparable to predicates ($1.400 \pm 0.005 \text{ nd}$ for predicate 1, $1.4002 \pm 0.005 \text{ nd}$ for predicate 2). | $1.390 \pm 0.005 \text{ nd}$ |
| Biocompatibility | Non-toxic and biocompatible with ocular environment (demonstrated via ISO 10993 series tests). | Passed Cytotoxicity, Ocular Irritation, Acute Systemic Toxicity, Skin Sensitization tests for lens, packaging solution, and packaging materials. |
| Physical/Optical Properties | Within established specifications (references ISO 18369-4:2017, ISO 18369-3:2017, and FDA Guidance Document for Daily Wear Contact Lenses, 1994). | "The physical, optical and chemical properties of the lens are within established specifications." |
| Mechanical Properties | Tested and within specifications. | Tested and within specifications. |
| Shelf-life | Verified and within specifications. | Verified and within specifications. |
| Physical Compatibility with Packaging Solution | Verified and within specifications. | Verified and within specifications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical laboratory testing and a substantial equivalence argument, not a clinical trial with human subjects for device performance. Therefore:
- Sample size: The document does not specify exact sample sizes for each type of non-clinical test (e.g., how many lenses were tested for Dk, how many samples for cytotoxicity). It broadly refers to "a series of preclinical testing."
- Data Provenance: The document is a regulatory submission from "Yung Sheng Optical Co., Ltd" in Taichung City, Taiwan. The testing itself would have been performed in laboratories (likely in Taiwan) according to international standards (ISO) and FDA guidance. This is retrospective in the sense that the data was collected prior to the submission for clearance.
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)
This is not applicable as this submission relates to a physical medical device (contact lens) and relies on objective, measurable physiochemical and biological properties, not human interpretation of medical images or data requiring expert consensus for "ground truth." The "ground truth" for these tests comes from established scientific methods, physical measurements, and biological assays.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as above. Adjudication methods are relevant for subjective assessments, typically in clinical readings or interpretations, which are not part of this device's non-clinical testing.
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
This is not applicable. This is a contact lens, not an AI-powered diagnostic or assistive device. No MRMC study was performed or needed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation comes from:
- Objective material and physical property measurements: e.g., water content, Dk, light transmittance, refractive index.
- Standardized biological assays: e.g., ISO 10993 series for biocompatibility (cytotoxicity, irritation, systemic toxicity, sensitization).
- Comparison to established specifications and predicate device characteristics.
There is no "expert consensus" or "pathology" in the context of typical AI model ground truth for this type of device.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of an AI model for this device. The manufacturer relies on knowledge gained from prior research, development, and testing of materials (Omafilcon A) and manufacturing processes, along with the performance of predicate devices.
9. How the ground truth for the training set was established
This is not applicable as there is no AI training set. The "ground truth" for the overall understanding of contact lens materials and design is established through decades of ophthalmic research, material science, clinical trials of similar devices, and regulatory standards.
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