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510(k) Data Aggregation
(273 days)
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear and Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens are 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 reusable daily wear in a Frequent Replacement Program.
DISPOSABLE WEAR:
When prescribed for Disposable Wear, the Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens is to be discarded after each removal.
FREQUENT/PLANNED REPLACEMENT WEAR:
When prescribed for Frequent/Planned Replacement Wear, the Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear 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.
The Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear and Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens are hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Otufilcon A, which is a 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 lens is marked with wording "321" to help user better distinguish the correct side before inserting in eyes.
The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with A) PMB Packaging Solution, or B) Cyanocobalamin Packaging Solution depends on customer's requirement.
N/A
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(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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(384 days)
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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(60 days)
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 | < 50 % | < 50 % |
| UV-B Transmittance | < 5 % | < 5 % |
| Refractive Index | 1.409 (± 0.005 nd) | 1.409 (± 0.005 nd) |
| Base Curve | 8.60 (± 0.20 mm) | 7.85 ~ 10.00 (± 0.20 mm) |
| Diameter | 14.20 (± 0.20 mm) | 12.00 ~ 15.00 (± 0.20 mm) |
| Tint | C.I. Reactive Blue #4 for handling purpose | C.I. Reactive Blue #4 for handling purpose |
| Packaging Solution | Phosphate buffered saline solution | Phosphate buffered saline solution containing sodium hyaluronate and trehalose. |
| Toxicity (Acute Systemic Injection) | Non-toxic (implied by predicate) | Meets requirements, non-toxic |
| Toxicity (White Rabbit Ocular Irritation) | No ocular irritation (implied) | No ocular irritation |
| Toxicity (Cytotoxicity) | Meets ISO 10993-5 (implied) | Meets ISO 10993-5 |
| Extractables (Leachability) | Demonstrated safety (implied) | Performed, equivalent to predicate |
| Finished Lens Parameters | Matches predicate (implied) | Performed, equivalent to predicate |
| Water Content | 55% (explicitly stated) | Performed, equivalent to predicate |
| Shelf-life | Demonstrated stability (implied) | Performed, equivalent to predicate |
| Mechanical Properties Comparative Testing | Matches predicate (implied) | Performed, equivalent to predicate |
| Physical Compatibility with Contact Lens Care Solution and Packaging Solution | Demonstrated compatibility (implied) | Performed, equivalent to predicate |
Note: For properties like "Powers", "Base Curve", and "Diameter", the subject device offers a broader range, which is typically acceptable if the safety and performance for the new range are demonstrated, often through bridging data or established manufacturing controls, and the material and fundamental design remain equivalent.
The packaging solution for the subject device is more specific but still within the expected range of saline solutions for contact lenses.
2. Sample size used for the test set and the data provenance
The document states: "A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens." However, it does not specify the exact sample sizes for each non-clinical test (e.g., number of lenses, animals tested).
- Data Provenance: The tests were conducted by Yung Sheng Optical Co., Ltd. (Taiwan). The nature of the tests (e.g., in-vitro, animal studies) means they are primarily lab-based and not derived from human patient data in the clinical trial sense. The status is "preclinical testing".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this premarket notification for a contact lens. The "ground truth" for contact lens performance is established through standardized non-clinical (bench) testing, material characterization, and established clinical performance of the material. Expert consensus, in the diagnostic sense, is not typically used here. The assessment is based on physical and chemical measurements against industry standards and comparisons to a legally marketed predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials involving human readers assessing medical imaging or other diagnostic outputs to establish ground truth or resolve discrepancies. This document describes non-clinical testing of a physical device.
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
Not applicable. MRMC studies are specific to evaluating diagnostic systems, particularly those involving AI assistance with human interpretation. This document pertains to a contact lens and its physical/chemical properties.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This question relates to AI/ML software performance. The device is a contact lens.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is established by:
- Standardized Test Methods: Adherence to established standards (e.g., ISO 10993-5 for cytotoxicity, FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, 1994).
- Material Specifications: Chemical and physical properties of the Methafilcon A material and the finished lens parameters (e.g., water content, light transmittance, refractive index).
- Predicate Device Equivalence: The primary "ground truth" or benchmark is the performance and safety profile of the legally marketed predicate device (K133735), which has already been deemed safe and effective.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms.
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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(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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(72 days)
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 | < 50 % | < 50 % |
| UV-B Transmittance | < 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 ± 0.20 mm |
| Diameter | 14.00 ± 0.20 mm | 12.00 ~ 15.00 ± 0.20 mm |
| Center Thickness | 0.044 ~ 0.131 mm (varies with power) | 0.060 ± 0.020 mm |
| Tint | C.I. Reactive Blue No. 4 | C.I. Reactive Blue No. 4 |
| Toxicity (Acute Systemic Injection) | Meets requirements of systemic injection test (non-toxic) | Meets requirements of the systemic injection test and is considered non-toxic. |
| Toxicity (White Rabbit Ocular Irritation) | No ocular irritation | Produced no ocular irritation. |
| Toxicity (Cytotoxicity) | Meets requirements of ISO 10993-5 | Meets the requirements of ISO 10993-5. |
| Extractables (Leachability) | - (Tested to demonstrate safety) | Performed (demonstrated safety) |
| Finished Lens Parameters | - (Tested to demonstrate safety/effectiveness) | Performed (demonstrated safety/effectiveness) |
| Shelf-life | - (Tested to demonstrate safety/effectiveness) | Performed (demonstrated safety/effectiveness) |
| Mechanical Properties | - (Comparative testing performed) | Performed (demonstrated equivalence) |
| Specific Gravity | - (Comparative testing performed) | Performed (demonstrated equivalence) |
| Physical Compatibility with Solutions | - (Tested to demonstrate safety/effectiveness) | Performed (demonstrated safety/effectiveness) |
Note: For the test items without specific numerical acceptance criteria in the predicate column, the acceptance criterion is that the new device's performance is demonstrated to be equivalent or safe and effective, as required for a 510(k) submission.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test. It states that "A series of preclinical testing were performed" and lists the types of tests. These tests are generally conducted on a representative sample of the devices.
The data provenance is Taiwan, as the manufacturer is based in Taichung City, Taiwan, and the tests were performed to support the 510(k) submission for the US market. The study is considered prospective for the new device's testing, as samples of the new device were specifically tested according to recommended FDA guidelines.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies performed are non-clinical (bench testing and biological safety tests) and do not typically involve human experts establishing a "ground truth" in the same way clinical studies for AI models do. Compliance with standards and regulatory requirements is typically assessed by designated test personnel and internal/external auditors.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are non-clinical tests measuring physical parameters and biological responses, not expert review or diagnostic performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This document describes the submission of a contact lens, which is a physical medical device, not an AI-powered diagnostic tool requiring MRMC studies.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a contact lens and does not involve an algorithm or AI. All the testing performed can be considered "standalone" in the sense that it's the performance of the device itself being measured, without human-in-the-loop interaction in the context of an AI system.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is established by:
- Established Test Methods and Standards: e.g., ISO 10993-5 for cytotoxicity.
- Predicate Device Specifications: physical parameters are compared directly to the known specifications of the legally marketed predicate device.
- Regulatory Guidance: The tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical contact lens, not an AI model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
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(54 days)
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 | < 50 % | < 50 % | < 50 % |
| UV-B | < 5 % | < 5 % | < 5 % |
| Refractive Index | 1.440 ± 0.005 nd | 1.440 ± 0.005 nd | 1.440 ± 0.005 nd |
| Base Curve | 8.6 ± 0.2mm (predicate) | 8.6 ± 0.2 mm | 8.7 ± 0.2 mm |
| Diameter | 14.0 ± 0.2mm | 14.0 ± 0.2 mm | 14.0 ± 0.2 mm |
| Center Thickness | 0.08 mm to 0.11 mm (predicate, varies with power) | 0.06 mm to 0.11 mm (varies with power) | 0.06 ± 0.02 mm |
| Toxicity | Non-toxic | Meets requirements; non-toxic | Meets requirements; non-toxic |
| Ocular Irritation | No ocular irritation | Produced no ocular irritation | Produced no ocular irritation |
| Cytotoxicity | Meets ISO 10993-5 | Meets ISO 10993-5 | Meets ISO 10993-5 |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical or AI performance evaluation. The "testing" referred to is primarily non-clinical bench testing. For these tests:
- Sample size: Not explicitly stated for each non-clinical test (e.g., how many lenses were used for extractables or mechanical properties).
- Data provenance: Taiwan (Yung Sheng Optical Co., Ltd., based in Taichung City, Taiwan). The tests were conducted to demonstrate equivalence to a predicate device already cleared by FDA, suggesting the data originates from the manufacturer's testing facilities or contracted labs. These are likely retrospective in the sense that they are conducted on manufactured samples, not as part of a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The submission is for contact lenses, and the "ground truth" for non-clinical tests (e.g., material properties, toxicity) is established by standard scientific and regulatory methods, not by expert consensus in a diagnostic sense.
4. Adjudication method for the test set
Not applicable. There is no diagnostic "test set" requiring adjudication by experts.
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
Not applicable. This device is a contact lens, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is based on:
- Standardized methods and accepted thresholds: For tests like toxicity (systemic injection, ocular irritation, cytotoxicity based on ISO 10993-5), accepted biological responses or lack thereof served as the ground truth.
- Physical and chemical specifications: For parameters like water content, refractive index, light transmittance, and dimensions, the ground truth is the measured value and its adherence to pre-defined specifications (often mirroring the predicate device's specifications).
8. The sample size for the training set
Not applicable. There is no AI component requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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(102 days)
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% | < 50% |
| UV-B Blockage | 9.41% | < 5% |
| Refractive Index | 1.402 | 1.409 |
| Base Curve | 8.40mm ~ 9.30mm | 8.4 mm ~ 8.8 mm (Accepted range, though predicate has wider) |
| Diameter | 14.0mm ~ 15.0mm | 14.0 mm ~ 14.4 mm (Accepted range, though predicate has wider) |
| Tint | Reactive Blue No. 4 | C.I. Reactive Blue #4 |
Note: The differences in 'Powers', 'Light Transmittance', 'UV-A', 'UV-B', 'Refractive Index', 'Base Curve', and 'Diameter' were deemed acceptable for substantial equivalence. For instance, the new device specifies '<5%' for UV-B blockage, while the predicate is 9.41%. This indicates the new device has better UV-B blocking, which is not a safety concern.
2. Sample Size Used for the Test Set and Data Provenance
No specific "test set" in the context of clinical data for AI evaluation is mentioned. The device's substantial equivalence is established through non-clinical testing, which included:
- Toxicity (Acute Systemic Injection Study, White Rabbit Ocular Irritation Test, Cytotoxicity Test)
- Extractables (Leachability)
- Finished Lens Parameters
- Light Transmittance
- Refractive Index
- Water Content
- Oxygen Permeability
- pH and Osmolality Test
- Shelf-life
- Mechanical Comparative Testing
No details are provided on the sample sizes for these specific non-clinical tests (e.g., number of lenses tested for parameters, number of animals in toxicity studies), nor is there information on data provenance in terms of country of origin or whether it was retrospective/prospective, as this is typically not relevant for bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The ground truth for proving the device meets acceptance criteria is based on established scientific and engineering principles for material characterization and biocompatibility, as outlined in FDA guidance for contact lenses. There were no human experts establishing ground truth for a test set in the context of AI or clinical evaluation.
4. Adjudication Method for the Test Set
Not applicable, as no human-adjudicated test set was used.
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
Not applicable. This device is a contact lens and does not involve AI or human readers for diagnostic interpretation. The evaluation is for physical, chemical, and biological compatibility properties.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests is based on:
- Established ASTM/ISO standards and validated testing methodologies for material properties (e.g., water content, Dk, light transmittance, refractive index, pH, osmolality, mechanical properties).
- Biocompatibility standards (e.g., ISO 10993-5 for cytotoxicity, and standard animal models for systemic injection and ocular irritation) to demonstrate safety.
- Comparison to the legally marketed predicate device (K013649), which has already established its safety and effectiveness based on similar ground truths.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI or machine learning device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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(102 days)
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) | < 50% (transmittance) | Meets UV blocking standards for Polymacon lenses. |
| UV-B | - (Not specified in table) | < 5% (transmittance) | Meets UV blocking standards for Polymacon lenses. |
| Refractive Index | 1.4375 | 1.440 $\pm$ 0.005 | Comparable to predicate. |
| Base Curve | 7.5mm ~ 9.5mm | 8.6 $\pm$ 0.2mm | Within acceptable range and comparable to predicate. |
| Diameter | 13.5mm ~ 15.5mm | 14.0 $\pm$ 0.2mm | Within acceptable range and comparable to predicate. |
| Tint | Reactive Blue Dye 246 | C.I. Reactive Blue #4 | Appropriate for visibility, and color additives are deemed safe. |
Summary of Non-Clinical Test Results (Meeting Implicit Acceptance Criteria):
The submission states that a series of preclinical tests were performed, and "The results of all testing demonstrated that the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is equivalent to the BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens (K020927).". The tested areas include:
- Toxicity:
- Acute Systemic Injection Study: Meets requirements, considered non-toxic.
- White Rabbit Ocular Irritation Test: No ocular irritation.
- Cytotoxicity Test: Meets ISO 10993-5 (non-cytotoxic).
- Extractables
- Finished Lens Parameters
- Light Transmittance
- Refractive Index
- Water Content
- pH and Osmolality
- Specific Gravity
- Physical Compatibility
- Oxygen Permeability
- Mechanical Comparative Testing
- Shelf-life test
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated numerically for each non-clinical test, but implied to be sufficient to meet regulatory standards for each specific test (e.g., number of rabbits for ocular irritation, samples for physical/chemical characterization). These are laboratory-based tests, not human clinical trials or large image datasets.
- Data Provenance: The tests were conducted by the manufacturer, Yung Sheng Optical Co., Ltd., in Taiwan. There is no mention of retrospective or prospective data in the context of clinical studies, as none were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the AI sense (e.g., expert annotation of medical images) does not apply here. The "truth" for these tests is established by standardized laboratory methods and regulatory guidelines (e.g., ISO standards, FDA recommendations).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no expert adjudication process over "test sets" as understood in AI/ML performance evaluation. Laboratory test results are interpreted against predefined specifications.
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:
- Not applicable. This is a contact lens submission, not an AI-powered diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's safety and performance is based on established scientific and engineering principles, standardized laboratory testing methodologies (e.g., ISO, FDA guidance documents), and demonstrated equivalence to a legally marketed predicate device. It's primarily material characterization, biocompatibility testing, and physical performance metrics rather than clinical outcomes or expert consensus.
8. The sample size for the training set:
- Not applicable. This is not an AI/Machine Learning device. There is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or AI model.
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