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510(k) Data Aggregation
(459 days)
Yung Sheng Optical Co., Ltd.
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) |
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(384 days)
Yung Sheng Optical Co., Ltd.
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia or hyperopia) in 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 practitioners may prescribe the contact lens for single use daily disposable. The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily disposable single use and should be discard after removal.
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear is hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Otufilcon A, which is a random copolymer of silicone-containing monomers and hydrophilic monomers, and has 44% 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 315 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive.
The Pure Plus UV Aspheric (Otufilcon A) Silicone 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 wetting agent.
This document describes the premarket notification for the "Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear".
1. Table of acceptance criteria and the reported device performance:
The document doesn't provide a specific table of acceptance criteria with corresponding performance metrics in a format directly mapping to typical AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating substantial equivalence to a predicate device through physiochemical properties, non-clinical tests, and a clinical study. The acceptance criteria for the clinical study are primarily related to non-inferiority in effectiveness and safety.
| Acceptance Criteria (Effectiveness) | Reported Device Performance (Effectiveness) |
|---|---|
| Corrected visual acuity of both eyes ≥ 1.0 with contact lens at 3-month (non-inferiority to control group) | The efficacy endpoints showed that the test group was non-inferior to the control group. The lenses in both groups were effective in vision correction and did not cause unwanted diopter changes in spherical or cylindrical power and corneal astigmatism. |
| Acceptance Criteria (Safety) | Reported Device Performance (Safety) |
| Incidence of adverse events not higher than in the control group | The incidence of adverse events was not higher than in the control group. |
| Ocular conditions remained normal at the end of the study | Ocular conditions remained normal at the end of the study. No unpredictable side effects were observed during the trial. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Clinical Study):
- Screened: 151 subjects
- Randomized and Enrolled: 144 subjects (73 in test group, 71 in control group)
- Completed the study: 139 subjects (70 in test group, 69 in control group)
- Data Provenance: The clinical study was conducted in Taiwan. It was a prospective, randomized, double-blind, parallel, active-controlled clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study involves visual acuity measurements and ocular examinations, which would typically be performed by trained medical professionals (e.g., ophthalmologists, optometrists), but the number and qualifications of these individuals are not specified as "experts establishing ground truth" in the context of an AI/ML device. For contact lenses, "ground truth" would relate to objective measurements of visual acuity and ocular health assessments, not typically expert consensus on interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not explicitly provided. Clinical studies for contact lenses often involve masked evaluators, but a formal adjudication method like "2+1" for discrepancies is not mentioned.
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 was not a multi-reader multi-case (MRMC) comparative effectiveness study. This study is for a contact lens, which is a medical device, not an AI/ML algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This was not a standalone performance study. Again, this document refers to a contact lens, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the clinical study, the ground truth for effectiveness was based on objective measurements of corrected visual acuity (≥ 1.0) with the contact lens. For safety, it was based on the incidence of adverse events and ocular health assessments. These are clinical outcomes and objective measurements.
8. The sample size for the training set:
This information is not applicable as this is not an AI/ML device and therefore does not have a "training set" in that context. The document refers to the manufacturing process and material characteristics, which are developed and tested, but not in the framework of machine learning training data.
9. How the ground truth for the training set was established:
This information is not applicable as this is not an AI/ML device.
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(256 days)
Yung Sheng Optical Co., Ltd
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 |
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(60 days)
YUNG SHENG OPTICAL CO., LTD.
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens 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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens 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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is manufactured by using cast molding method. The lens material, Methafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and Methacrylic acid (MAA) 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 text is related to the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens. It serves as a 510(k) summary for premarket notification to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device (K133735) rather than acting as a traditional clinical study report for a new medical device where complex acceptance criteria related to diagnostic performance might be required.
Therefore, the requested information regarding acceptance criteria and studies (e.g., MRMC, expert ground truth, training set details) that are typical for AI/ML-driven devices with diagnostic or prognostic capabilities is not applicable to this document. This document describes a contact lens and focuses on bench testing and material safety.
However, I can extract the "acceptance criteria" through the lens of substantial equivalence and the reported device performance related to the physical and chemical properties of the contact lens, as well as the non-clinical tests performed to demonstrate its safety and effectiveness.
Here's an interpretation of the requested information based on the provided text for the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (contact lens), the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (K133735) across various physical, chemical, and safety characteristics. The reported device performance is compared directly to the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device K133735) | Reported Device Performance (Subject Device) |
|---|---|---|
| Device Name | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens |
| Intended Use | Correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters; for astigmatism ≤ 2.00 diopters not interfering with visual acuity. Prescribed for daily disposable or daily wear in a Frequent Replacement Program. Disinfection with chemical or hydrogen peroxide systems. | Correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes; for astigmatism ≤ 2.00 diopters not interfering 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. Disinfection with chemical or hydrogen peroxide systems. |
| Material | Methafilcon A | Methafilcon A |
| Manufacturing Method | Cast Molded | Cast Molded |
| Water Content | 55 % | 55 % |
| Powers | -0.00 ~ -12.00 D | -0.50 D ~ -20.00 D |
| Light Transmittance | 95 % (± 5 %) | 95 % (± 5 %) |
| UV-A Transmittance |
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(96 days)
YUNG SHENG OPTICAL CO., LTD.
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 |
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(72 days)
YUNG SHENG OPTICAL CO., LTD.
The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is indicated for daily wear single use only 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 care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal: Therefore no cleaning or disinfecting is required. The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens 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 0.01 % sodium hyaluronate and 0.1 % trehalose wetting agents.
The document provided describes the Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens and its substantial equivalence to a predicate device, K132854. The submission focuses on non-clinical testing to demonstrate safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens" are established by demonstrating equivalence to the predicate device, "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K132854)." Performance is shown through comparative testing against the predicate's established characteristics.
| Test Item / Characteristic | Acceptance Criteria (Predicate Device K132854) | Reported Device Performance (Eye Secret 38 UV 1-Day) |
|---|---|---|
| Material | Polymacon | Polymacon |
| Manufacturing Method | Cast molding | Cast molding |
| Water Content | 38 % | 38 % |
| Powers | -0.50 D ~ -12.00 D | -0.50 D ~ -20.00 D |
| Light Transmittance (Overall) | 95 ± 5 % | 95 ± 5 % |
| UV-A Transmittance |
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(54 days)
YUNG SHENG OPTICAL CO., LTD.
The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens help protect against transmission of harmful UV radiation to the cornea and into the eye.
For Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, 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 Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are 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 from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4 and printed with an intermittent coating containing a combination of the following approved pigments: Copper Phthalocyanine, Reactive Black 5, Iron Oxide, Titanium Dioxide, Carbazole Violet and D&C Yellow No. 10. 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 0.01 % sodium hyaluronate and 0.1 % trehalose wetting agents.
The provided text details a 510(k) premarket notification for new contact lenses, asserting their substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence rather than establishing de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and specific performance metrics like sensitivity, specificity, and reader studies is not explicitly available in this document.
However, I can extract the closest available information related to the device's characteristics and the non-clinical testing performed to support its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating similar performance and characteristics to the predicate device (Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, K132854). The "reported device performance" are the characteristics of the new devices.
| Characteristic | Acceptance Criteria (Implied: Similar to predicate K132854) | Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Performance | Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens Performance |
|---|---|---|---|
| Regulatory Number | 886.5925 | 886.5925 | 886.5925 |
| Classification | II | II | II |
| Intended Use | Same as predicate | The same | The same |
| Prescription Use | Yes | Yes | Yes |
| Material | polymacon | polymacon | polymacon |
| Manufacturing Method | Cast Molded | Cast Molded | Cast Molded |
| Water Content | 38 % | 38 % | 38 % |
| Powers | -0.50 D ~ -12.00 D (predicate) | -0.00 D ~ -20.00 D | -0.00 D ~ -20.00 D |
| Light Transmittance | 95 % ± 5 % | 95 % ± 5 % | 95 % ± 5 % |
| UV-A |
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(102 days)
YUNG SHENG OPTICAL CO., LTD.
The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Eye Care professionals may prescribe the lens for 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 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is manufactured by using advanced cast molding method. The lens material, methafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA) 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 280~315 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.
The provided 510(k) summary (K133735) describes the "Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) Contact Lens." This device is a contact lens, and its acceptance criteria and the study proving it meets these criteria are established through a demonstration of substantial equivalence to a predicate device, the "SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear" (K013649).
The approval is based on non-clinical testing rather than a clinical study or AI performance evaluation. The review relies on the inherent equivalence of the new device to a previously approved one.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the characteristics of the predicate device, K013649. The new device demonstrates performance that is either identical or within acceptable limits of the predicate.
| Characteristic | Acceptance Criteria (Predicate Device K013649 Performance) | Reported Device Performance (Eye Secret 55 UV Aspheric) |
|---|---|---|
| Classification | 886.5925 (Class II) | 886.5925 (Class II) |
| Intended Use | Correction of ametropia (myopia and hyperopia) and astigmatism up to 2.00 Dioptres for daily wear. | Correction of ametropia (myopia) with astigmatism up to 2.00 Dioptres for daily wear. (Slight difference in 'hyperopia' indicated, but still considered substantially equivalent) |
| Prescription Use | Yes | Yes |
| Material | Methafilcon A | Methafilcon A |
| Manufacturing Method | Cast Molded | Cast Molded |
| Water Content | 55% | 55% |
| Dk (Oxygen Permeability) | 22.0 x 10^-11 (cm²/sec) (mlO₂/ml x mmHg) | 22.0 x 10^-11 (cm²/sec) (mlO₂/ml x mmHg) |
| Powers | ± 20.00D | 0 ~ -12.00 D (Accepted range, though predicate has wider) |
| Light Transmittance | 94.61% | 95% ± 5% |
| UV-A Blockage | 36.00% |
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(102 days)
YUNG SHENG OPTICAL CO., LTD.
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons 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 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.
The provided document is a 510(k) premarket notification for a contact lens, the "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies typical for novel medical devices or AI algorithms. As such, the information you're requesting regarding AI-specific acceptance criteria, test sets, expert ground truth, MRMC studies, and training sets is not applicable to this document.
The "study that proves the device meets the acceptance criteria" in this context refers to a series of preclinical (non-clinical) tests and a comparison to a predicate device, rather than human clinical trials or AI performance evaluations.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this contact lens submission, the "acceptance criteria" are not framed as specific performance thresholds for an AI algorithm's metrics (like sensitivity, specificity, or AUC). Instead, they are demonstrated through equivalence to a legally marketed predicate device and through non-clinical testing that proves the device meets established standards for contact lens safety and function.
The table below summarizes the key comparative data provided for the subject device and its predicate, which implicitly defines the "acceptance criteria" through equivalence.
| Item | Predicate Device (K020927) BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (Reported Performance) | Acceptance Criteria (Implicitly, Equivalence to Predicate) |
|---|---|---|---|
| Regulatory Number | 886.5925 | 886.5925 | Same as predicate |
| Classification | II | II | Same as predicate |
| Intended Use | Daily wear for correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less. | Daily wear for correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less. | Similar to predicate, with some indication differences that do not raise new safety/effectiveness concerns. |
| Prescription Use | Yes | Yes | Yes |
| Material | polymacon | polymacon | polymacon |
| Manufacturing Method | Cast Molded | Cast Molded | Cast Molded |
| Water Content | 38% | 38% | 38% |
| Powers | $\pm 20.00D$ | $-0.50D \sim -12.00 D$ | Demonstrated range is acceptable and supported by material properties. |
| Light Transmittance | $\ge 96%$ | $95% \pm 5%$ | Comparable to predicate. |
| UV-A | - (Not specified in table) |
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