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510(k) Data Aggregation
(132 days)
St. shine Optical Co., Ltd.
Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less does not interfere with visual acuitv.
Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.
Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multifocal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.
Saview SH 38 UV, Saview SH 38 UV toric, and Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is daily disposable wear or frequent replacement wear. Eye care practitioners may prescribe the lens for daily disposable wear, or for frequent replacement wear.
For a daily disposable wear lens, the lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
For a frequent replacement wear lens, the lens may be cleaned or disinfected using chemicals disinfecting systems (hydrogen peroxide disinfecting systems are not included).
Saview SH 38 UV, Saview SH 38 UV toric, Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens:
- The lens designs include spherical, toric and multifocal lenses.
- UV absorbing monomer is used. The transmittance are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
- Tinted blue [Phthalocyaninato(2-)] copper in color additives approved in 21 CFR Part 74 for use in medical device is used.
- The lens contains 38% water by weight and each lens is supplied sterile in a blister container in saline solution.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not provided.
Understanding the Device:
The device in question is a Soft (Hydrophilic) Contact Lens (Saview SH 38 UV, Saview SH 38 UV toric, and Saview SH 38 UV multifocal) made of Senofilcon A, which is visibility tinted. It's classified as a Class II medical device.
Key Point: This document is a 510(k) premarket notification decision letter, which means the manufacturer is asserting substantial equivalence to already legally marketed predicate devices, rather than proving efficacy from scratch through entirely novel clinical trials. The focus here is on demonstrating that the new device is as safe and effective as the predicate devices, primarily through non-clinical performance data and material comparisons. Therefore, many of the typical "AI/ML validation" questions (like number of experts, adjudication, MRMC studies, training set details) will likely not apply directly to this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting various ISO standards and FDA guidance documents for contact lenses. The comparison table provides specific performance data points of the subject device against its predicate devices.
| Property / Acceptance Criteria (Derived from Standards/Predicate) | Reported Device Performance (Saview SH 38 UV, Saview SH 38 UV toric, Saview SH 38 UV multifocal) |
|---|---|
| Intended Use | Matches predicate devices (K042275 & K051095) for correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic or not-aphakic persons with non-diseased eyes. |
| Material (USAN Name) | Senofilcon A (Matches Predicate K042275) |
| Material (Classification) | Group 5C (Silicone hydrogel: low water subgroup) (Matches Predicate K042275) |
| Water Content | 38% (Matches Predicate K042275, lower than K051095's 55%) |
| Visible Light Transmittance | ≥90% (Meets/Exceeds both predicates: K042275 at ≥78%, K051095 at 90.3%) |
| UV Transmittance | UVB , ISO 11737-1:2018, ISO 11737-2:2019, USP, ISO 11987:2012, ISO 18369-1:2017, ISO 18369-2:2017, ISO 18369-3:2017, ISO 18369-4:2017, ISO 14644-1:2015, ISO 14644-3:2019, NEBB: 2009. Tests include: Stability Test, Autoclave Validation, Sterilization Efficacy of BI, Sterility Test, Bioburden test, Clean Environment Test Controls Report. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a "test set" in the context of a separate, clinical performance study. The data provided refers to non-clinical testing of the device itself (e.g., physical, chemical, mechanical properties, biocompatibility, sterilization validation). These tests are typically performed on representative batches of the manufactured device according to established protocols and standards, but the specific number of lenses or samples tested for each property is not detailed in this summary.
- Data Provenance: The manufacturer is St. Shine Optical Co., Ltd. from New Taipei City, Taiwan. The non-clinical testing appears to have been conducted by the manufacturer or their designated labs. The information provided does not specify if any data for this device was from other countries, though the predicate device K051095's ownership was transferred to St. Shine Optical. The studies are non-clinical (laboratory/in-vitro) as opposed to retrospective or prospective patient studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable / Not provided. This information is typically relevant for studies involving human interpretation (e.g., AI in radiology). For a contact lens 510(k) submission, "ground truth" and expert consensus would refer to established scientific and engineering principles, and validated test methods (e.g., ISO standards) for measuring physical, chemical, and biological properties, not human interpretative tasks. The "experts" involved are the individuals performing and overseeing the technical and scientific tests (e.g., chemists, material scientists, microbiologists), and the regulatory bodies (FDA) that review the compliance with standards.
4. Adjudication Method for the Test Set
- Not applicable / Not provided. Adjudication is relevant when multiple human readers/reviewers provide subjective opinions that need to be reconciled, particularly in imaging or clinical diagnostic studies. The non-clinical testing described here relies on objective measurements and standardized test methods, where results are compared against predetermined specifications and ISO standards, not subject to human adjudication in the same way.
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-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant to its regulatory pathway.
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 or AI. It is a physical medical device (contact lens).
7. The Type of Ground Truth Used
- The "ground truth" for this submission are the established physical, chemical, and biological performance specifications and safety profiles for contact lenses, as defined by:
- Relevant ISO standards (e.g., ISO 11981, ISO 18369 series, ISO 17665-1, ISO 10993 series for biocompatibility).
- FDA guidance documents (e.g., 1994 FDA Guidance Document for Daily Wear Contact Lenses, FDA Guidance for Color Additives).
- Performance characteristics of the predicate devices (K042275 and K051095), which the subject device aims to be substantially equivalent to.
- GLP regulations (21 CFR Part 58) for biocompatibility tests.
8. The Sample Size for the Training Set
- Not applicable / Not provided. There is no "training set" in the context of AI/machine learning for this device. The manufacturing process and quality control would involve internal development and validation data, but this is not a "training set" like in AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not provided. Since there is no "training set," this question does not apply. The "ground truth" for demonstrating safety and effectiveness relies on standard testing methodologies and comparison to known safe and effective predicate devices and regulatory standards, as described in point 7.
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(63 days)
ST. SHINE OPTICAL CO., LTD.
The Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with nondiseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.
The Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with nondiseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors Aqua 42 UV lens also acts to enhance or alter the apparent color of the eye.
Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing compound 2-[3-(2H-Benzotriazol-2y1)-4-hydroxyphenyl] ethyl methacrylate is incorporated into the lens polymer. The lens contains 42% water by weight and each lens is supplied sterile in a blister container containing hyaluronic acid polymer in saline solution. The lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, phthalocyanine green and carbazole violet listed in 21 CFR Part 73 and [phthalocyaninato (2-)] copper list in 21 CFR Part 74. The lens designs include spherical, toric and multifocal lenses.
This document pertains to a 510(k) premarket notification for Saview-Colors Aqua 42 UV (hefilcon A) Soft (hydrophilic) contact lenses. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove specific performance criteria of an AI/ML powered medical device. Therefore, many of the requested categories related to medical device performance and AI/ML studies are not applicable to this document.
However, I can extract information related to the non-clinical testing performed and the comparison to predicate devices, which serves a similar purpose of demonstrating safety and effectiveness based on established criteria for contact lenses.
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Parameters):
| Acceptance Criteria Category/Test | Reported Device Performance (Saview-Colors Aqua 42 UV) | Predicate Device 1 (Saview-Colors 42 UV, K123484) | Predicate Device 2 (Saview-Aqua 55 UV, K121201) |
|---|---|---|---|
| Material (Classification) | hefilcon A (Group 1) | hefilcon A (Group 1) | methafilcon A (Group 4) |
| Indication for Use | myopia, hyperopia, presbyopia and astigmatism | myopia, hyperopia, presbyopia and astigmatism | myopia, hyperopia, presbyopia and astigmatism |
| Water Content | 42% | 42% | 55% |
| Visible Light Transmittance | 97.06% | 97.06% | 96.78% |
| UV-A Transmittance | 9.22% | 9.22% | 12.370% |
| UV-B Transmittance | 0.49% | 0.49% | 1.025% |
| Dk (35° C) | $10.89 \times 10^{-11}$ | $10.89 \times 10^{-11}$ | $21.4 \times 10^{-11}$ |
| Powers | +12.00D to -20.00D | +12.00D to -20.00D | +12.00D to -20.00D |
| Refractive Index | 1.4347 (wet) | 1.4347 (wet) | 1.404 (wet) |
| Method of Manufacture | Moulded | Moulded | Moulded |
| Packaging | PP Blister Pack | PP Blister Pack | PP Blister Pack |
| Colorants | Iron oxides, Titanium dioxide, [Phthalocyaninato (2-)] copper, Phthalocyanine green, Carbazole violet | Iron oxides, Titanium dioxide, [Phthalocyaninato (2-)] copper, Phthalocyanine green, Carbazole violet | Copper phthalocyanine (visibility tinted) |
| Package Storage (Saline Solution) | Saline solution containing hyaluronic acid polymer | Saline solution containing hyaluronic acid polymer | Saline solution |
| Stability Testing | Performed, lenses remain sterile and properties do not change before expiration date. | Not explicitly detailed but implied for predicate. | Not explicitly detailed but implied for predicate. |
| Toxicology Testing | Cytotoxicity: showed substantial equivalence. Ocular Irritation: showed substantial equivalence. Acute Systemic Injection: showed substantial equivalence. | Not explicitly detailed but implied for predicate. | Not explicitly detailed but implied for predicate. |
| Physical/Chemical Testing | Performed (results summarized above in comparison table). | Not explicitly detailed but implied for predicate. | Not explicitly detailed but implied for predicate. |
Information not applicable or not found in the provided document, based on the nature of this 510(k) submission for contact lenses:
- Sample sized used for the test set and the data provenance: This document describes non-clinical and physical/chemical testing, not a "test set" in the context of an AI/ML model. The specific sample sizes for tests like stability, cytotoxicity, etc., are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not mentioned for these tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device requiring expert ground truth for a diagnostic outcome.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/ML powered device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML powered device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML device. For the contact lens, the "ground truth" for non-clinical tests would be established by validated test methodologies and specifications for safety and performance (e.g., ISO standards for biocompatibility, physical properties for contact lenses).
- The sample size for the training set: Not applicable, as this is not an AI/ML powered device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML powered device.
Summary of Device Meeting Acceptance Criteria:
The document explicitly states that "Information submitted in the 510(k) establishes that the Saview-Colors Aqua 42 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness." It further concludes that the results of stability testing, acute systemic injection, ocular irritation, and in vitro cytotoxicity tests showed the Saview-Colors Aqua 42 UV lenses are substantially equivalent to the predicate device in safety and biocompatibility.
The acceptance criteria are implied to be the established safety and performance profiles, including physical characteristics and biocompatibility, demonstrated by the legally marketed predicate devices. The study proving the device meets these criteria involved a series of non-clinical tests as recommended by the "Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994." These tests focused on:
- Stability Testing: To ensure lenses remain sterile and properties do not change before the expiration date.
- Toxicology Testing: Including Cytotoxicity, Ocular Irritation, and Acute Systemic Injection to confirm biocompatibility.
- Physical/Chemical Testing: To characterize properties like water content, transmittance, Dk, powers, refractive index, etc., and compare them to predicate devices.
Clinical testing was explicitly stated as NOT required for this submission, indicating that the non-clinical data and comparison to predicate devices were sufficient to demonstrate substantial equivalence for the specified indications for use.
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(50 days)
ST. SHINE OPTICAL CO., LTD.
The Saview-Aqua 58 UV (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The Saview-Aqua 58 UV Toric (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity.
The Saview-Aqua 58 UV Multifocal (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters.
The Saview-Aqua 58 UV, Saview-Aqua 58 UV Toric and Saview-Aqua 58 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
The lens material (etafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with 1, 1, 1-trimethylol propane trimethacrylate. A UV absorbing monomer, 2-[3-(2H-Benzotriazol-2y1)-4hydroxyphenyl]] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The UV blocker for Saview-Aqua 58 UV (etafilcon A) Visibility tinted Soft (Hydrophilic) Contact Lens averages 85.063 % in the UVA range of 316 nm to 380 nm and 97.984 % in the UVB range of 315 nm to 280 nm. The lens contains 58% water by weight and each lens is supplied sterile in a blister container containing SYS TO.2 % hyaluronic acid polymer in saline solution. The lens is visibility tinted Pigment Blue 15(Copper phthalocyanine) to make the lens more visible for handling.
The Saview-Aqua 58 UV (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as a single vision lens.
The Saview-Aqua 58 UV Toric (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.
The Saview-Aqua 58 UV Multifocal (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.
The provided document is a 510(k) summary for contact lenses and does not describe AI/ML device performance, acceptance criteria, or a study that evaluates such a device. Since the request pertains to AI/ML device performance and related studies, and the document is not about an AI/ML device, I cannot fulfill the request based on the provided text.
The document focuses on the substantial equivalence of new contact lenses to previously approved predicate devices, based on material properties, chemical composition, and non-clinical testing (stability, toxicology, physical/chemical testing). It explicitly states: "Clinical data is not required for this submission."
Therefore, I cannot provide information on:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for an AI/ML device.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance of an AI/ML algorithm.
- Type of ground truth for an AI/ML device.
- Sample size for the training set or how ground truth for the training set was established for an AI/ML device.
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(136 days)
ST. SHINE OPTICAL CO., LTD.
The Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors 42 UV also acts to enhance or alter the apparent color of the eye.
The Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.
The Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the corrective ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors 42 UV lens also acts to enhance or alter the apparent color of the eye.
Eve care practitioners may prescribe the lenses for single use disposable wear or frequent replacement. When prescribed for a Disposable Wearing Schedule, the lenses are not intended to be cleaned or disinfected and should be discarded after a single use. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
The Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA), and using azobisisobutyronitrile (AIBN) as the initiator. A compound 22-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl] UV absorbing ethvl methacrylate is incorporated into the lens polymer. The lens contains 42% water by weight and each lens is supplied sterile in a blister container in saline solution. The lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, phthalocyanine green and carbazole violet listed in 21 CFR Part 73 and [phthalocyaninato (2-)] copper list in 21 CFR Part 74.
The Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is available as a single vision lens.
The Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.
The Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.
The provided document is a 510(k) summary for contact lenses and does not describe AI/ML device performance or acceptance criteria in the context of diagnostic accuracy. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. Therefore, most of the requested information regarding AI/ML device performance and study design cannot be extracted.
However, I can extract the acceptance criteria and device performance information related to the physical and chemical properties of the contact lenses, as presented in the "Comparison Chart" (Table 1).
Here's the available information presented in the requested format, with notes indicating why certain sections are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For the purpose of this 510(k), the "acceptance criteria" appear to be meeting or being substantially equivalent to the properties of the predicate devices. The document explicitly states: "Information submitted in the 510(k) establishes that the Saview-Colors 42 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness."
| Metric | Acceptance Criteria (Predicate Device K040900) | Acceptance Criteria (Predicate Device K050213) | Reported Device Performance (Saview-Colors 42 UV) |
|---|---|---|---|
| Material (Classification) | hefilcon A (Group 1) | nelfilcon A (Group 2) | hefilcon A (Group 1) |
| Indication for use | myopia, hyperopia, presbyopia and astigmatism | myopia, hyperopia, presbyopia and astigmatism | myopia, hyperopia, presbyopia and astigmatism |
| Water content | 42 % | 69 % | 42 % |
| Visible light transmittance | 90.3 % | Clear ≥ 97 %, Vistint 96 % | 97.06 % |
| UV Transmittance |
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(190 days)
ST. SHINE OPTICAL CO., LTD.
The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wcar for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive am etropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity.
The Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) the correction of refractive ametropia Contact Lens is indicated for daily wear for (myopia and hyperopia) and presbyopia in aphakic or or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters.
The Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric and Saview-Aqua 55 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.
The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate, and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The UV blocker for Saview-Aqua 55 UV (methafilcon A) Visibility tinted Soft (Hydrophilic) Contact Lens averages 87.630 in the UVA range of 316 nm to 380 nm and 98.975 % in the UVB range of 315 % nm to 280 nm. The lens contains 55% water by weight and each lens is supplied sterile in a blister container containing 0.2 % hyaluronic acid polymer in saline solution. The lens is visibility tinted using Pigment Blue 15(Copper phthalocyanine) to make the lens more visible for handling.
The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as a single vision lens.
The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.
The Savicw-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Saview-Aqua 55 UV contact lenses:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily demonstrates substantial equivalence to predicate devices rather than establishing specific, new acceptance criteria for the Saview-Aqua 55 UV lenses against numerical targets. Instead, the "acceptance criteria" are implicitly understood to be meeting or exceeding the performance characteristics of the predicate devices. The study compares key physicochemical properties.
| Characteristic | Acceptance Criteria (Implied: Comparable/Better than Predicate K051095 and K090806) | Saview-Aqua 55 UV Reported Performance | Predicate K051095 Performance | Predicate K090806 Performance |
|---|---|---|---|---|
| Material | methafilcon A (Group 4) | methafilcon A (Group 4) | methafilcon A (Group 4) | methafilcon A (Group 4) |
| Indication for use | myopia, hyperopia, presbyopia, astigmatism | myopia, hyperopia, presbyopia, astigmatism | myopia, hyperopia, presbyopia, astigmatism | myopia, hyperopia, presbyopia, astigmatism |
| Water content | 55% | 55% | 55% | 55% |
| Visible light transmittance (381 nm ~ 780 nm) | ≥ 90.3% (from predicates) | 96.78% | 90.3% | 90.30% |
| UV Transmittance | ≤ 9.1% (from predicate K051095) | 6.7% | 9.1% | 9.3% |
| UVA (316 nm ~ 380 nm) | ≤ 15.816% (from predicate K051095) | 12.370% | 15.816% | (Not specified) |
| UVB (280 nm ~ 315 nm) | ≤ 2.435% (from predicate K051095) | 1.025% | 2.435% | (Not specified) |
| Dk (35°C) | ≥ 18.9 x 10^-11 (from predicates) | 21.4 x 10^-11 | 18.9 x 10^-11 | 18.9 x 10^-11 |
| Powers | Comparable range to predicates | +12.00D to -20.00D (single vision); Cylinder -0.50D to -2.50D (Toric); Add to +3.25 (Multifocal) | +4.00D to -20.00D (single vision); Cylinder -0.50D to -2.50D (Toric); Add to +3.25 (Multifocal) | +4.00D to -20.00D (single vision); Cylinder -0.50D to -2.50D (Toric); Add to +3.25 (Multifocal) |
| Color | Pigment blue 15 | Pigment blue 15 | Pigment blue 15 | Pigment blue 15 |
| Refractive index (wet) | Comparable to predicates | 1.404 | 1.410 | 1.410 |
| Method of manufacture | Moulded | Moulded | Moulded | Moulded |
| Package Storage saline solution | Saline solution (some may contain hyaluronic acid polymer) | Saline solution containing hyaluronic acid polymer | Saline solution | Saline solution with hyaluropolymer |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "pre-clinical tests" and "physicochemical testing" but does not specify numerical sample sizes for these tests. It indicates the data comes from tests performed by St. Shine Optical Co., Ltd. in Taiwan, R.O.C. (the submitter). The data is generated prospectively for the purpose of this submission, but not in the context of a clinical trial on human subjects for device performance. It focuses on material properties and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable and not provided. The "ground truth" for these tests relates to the inherent physical and chemical properties of the lenses and their biological safety as tested in vitro or in animal models, not human diagnostic interpretation.
4. Adjudication Method for the Test Set:
Not applicable. There is no human interpretation or adjudication process described for the physicochemical and biocompatibility testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a contact lens submission, not an AI-powered diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a contact lens submission, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this type of submission is based on:
- Physicochemical Measurements: Standardized laboratory tests to determine properties like water content, transmittance, Dk, refractive index, etc.
- Biocompatibility Standards: Results from tests showing non-toxicity, non-irritation, and absence of unsafe residues, typically assessed against established biological safety standards for medical devices (ISO 10993 series, though not explicitly cited, is standard practice).
- Sterility Testing: Ensuring the product remains sterile until the expiration date.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI model requiring 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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(176 days)
ST. SHINE OPTICAL CO., LTD.
The Saview 58 UV (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-disease eyes that may exhibit refractive and/or corneal astigmatism up to 1.00 diopters that does not interfere with visual acuity. Saview 58 UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Saview 58 UV Toric (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. Saview 58 UV Toric lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Saview 58 UV Multifocal (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or non-aphakic persons with non-disease eyes that may exhibit refractive and/or corneal astigmatism up to 1.00 diopters that does not interfere with visual acuity. Saview 58 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
The Saview 58 UV, Saview 58 UV Toric and Saview 58 UV Multifocal (etafilcon A) Soft (hydrophilic) Contact Lenses are available as a spherical lens for single vision. astigmatic (toric) lens and aspherical multifocal lens respectively. The lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with 1,1,1-trimethylol propane trimethacrylate, initiated by Azobisisobutyronitrile. A UV absorbing compound 2-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl]ethyl methacrylate is incorporated into the lens polymer. The Saview 58 UV, Saview 58 UV Toric and Saview 58 UV Multifocal (etafilcon A) Soft (hydrophilic) Contact Lenses with visible tint are tinted blue using Pigment Blue 15 to make the lens more visible for handling.
This 510(k) summary describes a series of pre-clinical tests performed to demonstrate the safety and effectiveness of the Saview 58 UV contact lenses and to establish substantial equivalence to predicate devices. It does not contain information about a study based on human subjects or clinical data in the traditional sense of a device performance study.
Therefore, many of the requested elements (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set information) are not applicable or cannot be extracted from this document, as they relate to clinical performance evaluation, which was not the primary method of demonstrating substantial equivalence here.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for safety and effectiveness were primarily demonstrated through physicochemical equivalency and pre-clinical safety tests. The specific "acceptance criteria" are implied by the comparison to predicate device parameters and the successful completion of safety tests.
| PARAMETER | Saview 58 UV, Saview 58 UV Toric, and Saview 58 UV Multifocal (etafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (Reported Device Performance) | Predicate Device (ACUVUE - etafilcon A) Key Performance/Composition | Predicate Device (55 UV series - methafilcon A) Key Performance/Composition |
|---|---|---|---|
| Material | etafilcon A | etafilcon A | methafilcon A |
| Material Classification | Group 4 | Group 4 | Group 4 |
| Indication for Use | myopia, hyperopia, astigmatism, and presbyopia | myopia, hyperopia, astigmatism, and presbyopia | myopia, hyperopia, presbyopia and astigmatism |
| Water Content | 58% | 58% | 55% |
| Visible Light Transmittance | 91.752% | 88.592% | 90.3% |
| UV Transmittance | UVB 2.016%, UVA 14.937% | UVB 0.831%, UVA 11.894% | UVB 2.435%, UVA 15.816% |
| Dk (35°C) | 26.3 x 10^-11 | 28 x 10^-11 | 18.9 x 10^-11 |
| Powers | +12.00 ~ -12.00D | +20.00 ~ -20.00D | +4.00 ~ -20.00D |
| Color | Blue visibility, Pigment Blue 15 | Blue visibility, Reactive Blue #4 | Blue visibility, Pigment Blue 15 |
| Refractive Index | 1.3992 | 1.3988 | 1.415 |
| Method of Manufacture | Moulded | Moulded | Moulded |
| Acute Systemic Injection | Non-toxic | (Implied safe, as predicate) | (Implied safe, as predicate) |
| Ocular Irritation | Non-irritating | (Implied safe, as predicate) | (Implied safe, as predicate) |
| In Vitro Cytotoxicity | Non-toxic | (Implied safe, as predicate) | (Implied safe, as predicate) |
| Residue Evaluation | No evidence of unsafe amounts of residue | (Implied safe, as predicate) | (Implied safe, as predicate) |
| Shelf Life Testing | Lenses remain sterile and properties do not change before expiration date | (Implied stable, as predicate) | (Implied stable, as predicate) |
Study Proving Device Meets Acceptance Criteria:
A series of "pre-clinical tests" were performed. These tests focused on:
- Biocompatibility and Safety: Acute Systemic Injection, Ocular Irritation, and In Vitro Cytotoxicity Tests.
- Material Characterization: Physicochemical testing to compare properties like water content, UV transmittance, Dk, refractive index, etc., to the predicate devices.
- Residue Analysis: Evaluation for the presence of residue.
- Shelf Life Testing: To ensure sterility and property stability over time.
The conclusion states that the information submitted establishes that the Saview 58 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. This comparison to legally marketed predicate devices forms the basis of the "substantial equivalence" determination, not a standalone clinical performance study on the device's ability to correct vision.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document mentions "a series of pre-clinical tests" and "physicochemical testing" but does not detail the number of lenses or test articles used for each test.
- Data Provenance: The device manufacturer is St. Shine Optical Co., Ltd. in Taiwan. The pre-clinical tests and physicochemical evaluations would have been conducted by or for them, likely in a laboratory setting. The data is thus from laboratory testing, not a human clinical study with specific country of origin or retrospective/prospective designations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This document describes pre-clinical and physicochemical testing, not a clinical trial requiring human expert ground truth for diagnostic accuracy, for example.
4. Adjudication Method:
- Not applicable for the type of pre-clinical and physicochemical testing described.
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 not an AI-assisted diagnostic device, nor is an MRMC study mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a contact lens, not an algorithm. The device's "standalone" performance is assessed via its physical and chemical properties and biocompatibility as described in the pre-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these tests is based on established scientific methods and industry standards for material characterization, biocompatibility testing, and comparison against the known properties of the predicate devices. For example, specific analytical techniques provide data on water content, UV transmittance, Dk, etc., which are then compared to the predicate's values. Biocompatibility tests have their own endpoints (e.g., cell viability in cytotoxicity, absence of irritation in ocular irritation).
8. The sample size for the training set:
- Not applicable. There is no machine learning or AI component requiring a training set described in this document.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.
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(43 days)
ST. SHINE OPTICAL CO., LTD.
The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.
The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Evecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
The Saview 55 Multifocal (methafilcon A) Soft (hydrophilic) Daily Wear Contact Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent sclera. The Saview 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxvethyl methacrylate. methacrylic acid and diethlene glycol monomethacrylate, crosslinked with ethylene glycol dimethacrylate. The lens contains 55% water by weight. The lens is tinted using Pigment Blue 15.
The provided text is a 510(k) summary for a medical device (contact lens) and does not contain information about studies related to AI/ML device performance or acceptance criteria in the context of AI/ML.
Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (contact lenses) and its substantial equivalence to predicate devices based on physicochemical properties and manufacturing processes, not on an algorithm's performance. There is no mention of acceptance criteria or studies involving artificial intelligence, machine learning, or similar computational methods.
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(41 days)
ST. SHINE OPTICAL CO., LTD.
The Saview Toric 55 (methafilcon A) Soft (hydrophilic) Contact Lens for Daily 'Vear is indicated for daily wear for correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 Diopters.
Saview 55 Toric (methifilcon A) Soft (hydrophilic Contact Lens for Daily Wear
I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a contact lens, which primarily states that the device is substantially equivalent to a predicate device.
It does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details about sample sizes, data provenance, or ground truth establishment for any studies.
- Information on expert involvement, adjudication methods, or MRMC studies.
- Information on standalone algorithm performance or training sets.
Therefore, I cannot fulfill your request for this specific document.
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(46 days)
ST. SHINE OPTICAL CO., LTD.
The Saview 55F (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for correction of refractive ametropia (myopia and hyperopia) in aphakic or notaphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 1.00 Diopter that does not interfere with visual acuity.
The Saview 55F(methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear
The provided text is an FDA 510(k) clearance letter for the "Saview 55 (methafilcon A) Soft hydrophilic Contact Lens for Daily Wear." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and performance studies.
Specifically, the document does not provide any of the following information:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used or their qualifications for establishing ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size of human reader improvement with AI.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This letter solely states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance. The substantial equivalence determination means that the FDA believes the new device is as safe and effective as a previously cleared device. The specific performance data and acceptance criteria that led to this determination are typically found in the 510(k) submission itself, which is not provided in this public clearance letter.
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