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OCuSOFT® AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

OCuSOFT® AMENITY™ (linofilcon A) TORIC DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

OCuSOFT® AMENITY™ (linofilcon A) MULTIFOCAL DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are a hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution with added lubricants. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ contain C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling.

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >70% in the UVA range (316nm - 380nm).

The provided text is a 510(k) summary for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™. It details the similarity of the device to predicate devices rather than providing a standalone clinical study with specific acceptance criteria and performance results for the new device.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment for a standalone study is not explicitly present in the provided document. The document refers back to predicate device studies (K213216, K191929, K213119) for clinical and non-clinical data.

However, I can extract the material properties and their tolerances which act as performance criteria for the device itself.

Acceptance Criteria and Reported Device Performance

The provided document lists material properties and tolerances (acting as acceptance criteria) for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™. Since this is a 510(k) summary demonstrating substantial equivalence to predicate devices, the performance is generally asserted to meet these specified ranges, implying the device does meet these criteria. The table below presents these:

Study Information (Based on provided document)

1. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated for the device in this document. The document refers to "Non-clinical performance tests were performed to demonstrate the safety and effectiveness of the linofilcon A finished contact lenses in K213216." and "A clinical study was performed to demonstrate the safety and effectiveness of the linofficon A finished contact lenses in K213216." This implies the testing relevant to safety and effectiveness, including clinical performance, was primarily conducted for the predicate device K213216.
• Data Provenance: The manufacturing facility is in Hsinchu Science Park, Baoshan Township, Hsinchu County, Hsinchu – District, TAIWAN. The specific country of origin for clinical data (if separate from manufacturing) is not detailed. The non-clinical studies followed GLP regulations.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as the document does not describe a study involving expert assessment for ground truth establishment in the context of AI or diagnostic imaging. This device is a medical device (contact lens), not an AI diagnostic tool.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable for a contact lens safety and effectiveness study as described.

4. 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.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm. The device "OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™" is a physical contact lens. The "Non-Clinical Performance Testing" and "Bench Testing - Manufacturing Verification Testing" sections describe standalone testing of the physical properties and biocompatibility of the contact lenses.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical and bench testing, the ground truth would be based on established scientific measurement methodologies (e.g., ISO standards for biocompatibility, ANSI Z80.20 for contact lens parameters).
• For clinical studies (referenced to K213216), the ground truth for safety and effectiveness would likely involve clinical assessments by ophthalmologists/optometrists based on established clinical endpoints, patient reported outcomes, and adverse event monitoring.

7. The sample size for the training set:

• Not applicable. This is not an adaptive algorithm or AI, so there is no "training set."

8. How the ground truth for the training set was established:

• Not applicable.

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The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eye who may have 1.00 D or less astigmatism. The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear are single disposable wear and are to be discarded after each removal. UNICON (etaffilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is available as aspherical lenses manufactured by case-molding method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear with visible tint is light tinted blue using Blue 15:3 to make the lens more visible for handling. The lenses also contain a UV absorber { { 2-[ 3-( 2 -( 2 -( 2 -( ) - 4 - h dr ox y p hen y l which is included during the manufacturing process as a monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 30% in the UVA range of 316 to 380nm.

With more specific explanation, the "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear' is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from -6.50D to -13.00D in 0.50D per step.

The document provided is a 510(k) premarket notification for a soft contact lens. It aims to establish substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device.

Therefore, many of the requested elements (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set sample size, and ground truth establishment for the training set) are not applicable to this type of submission.

However, I can extract the acceptance criteria as defined by the non-clinical testing performed and compare them to the device's reported performance as presented in the "Substantial Equivalence Determination" section.

Here's an interpretation based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device (UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear) is asserting substantial equivalence to the VISTAKON (Etafilcon A) Soft (hydrophilic) Contact Lens (K051900). The "acceptance criteria" here are effectively the performance characteristics of the predicate device, which the proposed device aims to match or demonstrate equivalency to.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a "test set" in the context of an algorithm. For non-clinical tests (sterilization, shelf life, biocompatibility, mechanical properties, etc.), samples of the manufactured contact lenses would have been tested. The exact number of lenses or batches tested for each non-clinical parameter is not provided in this summary.
• Data Provenance: The non-clinical tests were performed in "UNICON QC lab and subcontracted test services" (Taiwan, based on submitter address). These are prospective tests on the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to this type of device submission. There is no mention of expert-established ground truth as would be relevant for an AI/algorithm.

4. Adjudication method for the test set:

Not applicable.

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, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by the established industry standards and recognized consensus standards (e.g., EN/ISO 17665 for sterilization, FDA guidance for daily wear contact lenses) which specify acceptable ranges or thresholds for each parameter. For example, for sterilization, achievement of a Sterility Assurance Level (SAL) of 10^-6 is the "ground truth" or acceptance criterion.

8. The sample size for the training set:

Not applicable. This is a manufactured physical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of Device Performance against Acceptance Criteria

The submission asserts that "All the test results were met the requirements of products specification" (page 6). The comparative table (pages 7-9) shows that the proposed device is largely identical or very similar to the predicate device across most physical, chemical, and performance characteristics.

Key observations:

• Intended Use, Material, Manufacturing, Sterilization, Water Content, UV Blocking: The proposed device matches the predicate.
• Power Range: The proposed device has a narrower power range (+6.00D to -13.00D) compared to the predicate (+20.00D to -20.00D). This is a difference, but typically a narrower range for a device is not considered a safety or effectiveness concern unless it fails to meet its own stated range.
• Specific Gravity: The proposed device (1.14) is slightly outside the predicate's range (0.98-1.12). The significance of this difference is not discussed in detail other than the general statement of substantial equivalence.
• Tensile Strength, Break Elongation, Secant Modulus: There are differences in these mechanical properties (Tensile Strength: 1.66 MPa vs 2.00 MPa; Break Elongation: 393% vs 189%; Secant Modulus: 0.43 MPa vs 1.06 MPa). The differences are significant in magnitude. The submission implicitly indicates these are acceptable variations for substantial equivalence.
• Oxygen Permeability: The proposed device (30.8 x 10^-11) has slightly higher oxygen permeability than the predicate (28 x 10^-11), which is generally a positive attribute for contact lenses.
• Visible Light Transmittance: The proposed device (Minimum 90%) has a slightly higher minimum transmittance than the predicate (Minimum 85%), also generally a positive attribute.
• Color & Tint / FDA Color Additive: This is identified as the main difference between the devices. The proposed device uses Blue 15:3 (Phthalocyaninato(2-)]copper) which is approved under 21 CFR 874.3045, while the predicate uses Reactive Blue Dye #4 (Poly(hydroxyethyl methacrylate)-dye copolymers) approved under 21 CFR 73.3121. The submission explicitly states that "the difference of proposed device and predicate device did not raise any problems of safety or effectiveness" and therefore does not impede substantial equivalence.

Conclusion from the document: The manufacturer concludes, and the FDA agrees by issuing the letter, that the UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is substantially equivalent to the predicate device based on the non-clinical tests performed and the comparison of characteristics. The clinical safety and effectiveness were established through the predicate device.

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