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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:

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The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 1.00 diopter (D) or less of astigmatism.

Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical disinfection system only.

The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lens. 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. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).

The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280mm -315nm), and >70% in the UVA range (316nm - 380nm).

The Oualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is manufactured in a spherical design configuration.

This document is a 510(k) Premarket Notification for a medical device, specifically a soft contact lens. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove a new level of performance or an AI's diagnostic capabilities. Therefore, many of the requested elements for an AI-based diagnostic device evaluation (like MRMC studies, expert consensus for ground truth establishment, training set details) are not relevant or present in this type of submission.

However, I can extract the relevant acceptance criteria and performance data provided for this specific type of device (a contact lens) which are typically focused on non-clinical and clinical safety and basic effectiveness parameters.

Here's the breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for many non-clinical tests are qualitative (e.g., "non-toxic," "no irritation") and are met by complying with relevant ISO standards. For quantitative metrics like Dk, water content, and refractive index, the device's measured values are compared to the predicate's known values to establish substantial equivalence.

2. Sample Size and Data Provenance

• Test Set Sample Size: 75 subjects were enrolled in the clinical study. 50 subjects wore the test lenses (Qualis) and 25 subjects wore the control lenses (Acuvue Vita). 73 of the 75 enrolled subjects completed the study.
• Data Provenance: Not explicitly stated regarding country of origin, but typical for FDA submissions, the clinical study would be conducted in a manner compliant with Good Clinical Practice (GCP) guidelines, often with a global reach or in the US. The study was "open-label, multi-center, randomized concurrent-control." It was a prospective study.

3. Number of Experts and Qualifications for Ground Truth

• This submission is for a contact lens, not an AI diagnostic device. Therefore, the concept of "ground truth" derived from expert consensus on diagnostic images is not applicable here. The "ground truth" for the clinical study would refer to the observed clinical outcomes (biomicroscopy findings, symptoms, vision safety measures) as assessed by the participating clinicians. The qualifications of these clinicians are not specified in the summary but would typically be licensed optometrists or ophthalmologists experienced in fitting and evaluating contact lenses.

4. Adjudication Method for the Test Set

• Not applicable in the context of a contact lens clinical trial, which primarily gathers objective and subjective clinical measurements directly, rather than judgments that require adjudication for a "ground truth."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic imaging devices to assess the impact of AI assistance on human reader performance. This submission is for a contact lens.

6. Standalone (Algorithm only) Performance

• No, standalone performance (i.e., algorithm only without human-in-the-loop performance) was not done. This is not an AI device.

7. Type of Ground Truth Used

• The "ground truth" for the clinical study in this context is based on clinical observations, measurements, and patient-reported symptoms as assessed by Eye Care Professionals during the 91-day follow-up. This includes biomicroscopy findings, assessment of symptoms, and vision safety measures. Non-clinical "ground truth" is based on bench testing and laboratory analyses against established scientific methods and standards (e.g., ISO standards for biocompatibility).

8. Sample Size for the Training Set

• Not applicable. This is not an AI device that requires a training set in the machine learning sense. The "training" for such a device is its manufacturing process and quality control.

9. How Ground Truth for the Training Set Was Established

• Not applicable as this is not an AI device.

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The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 6.00 diopters (D) or less of astigmatism.

Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical disinfection system only.

Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is available as aspherical lenses manufactured by cast-molding method. The material is a high water content (59 % wt/wt) material. The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate), which was cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens with visible tint is light tinted blue using C.I Reactive Blue 246 to make the lens more visible for handling. The lenses also contain a UV absorber {2-[3-(2H-Benzotriazol-2-yl)-4-hydroxypheny] ethyl methacrylate} which is included during the manufacturing process as an additive 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 provided text is related to a 510(k) premarket notification for a soft contact lens and focuses on demonstrating substantial equivalence to a predicate device. It does not describe a study involving an AI device, human readers, or the establishment of ground truth in the context of medical imaging or diagnostic aid. Therefore, I cannot extract the information requested as it is not present in the document.

Specifically, the document states:

• "No clinical test data was used to support the decision of substantial equivalence." (Page 6, Section 5.9 Clinical Testing)
• The studies conducted were non-clinical safety and performance studies for the contact lens, such as sterilization validation, shelf-life, biocompatibility, and material performance (e.g., water content, oxygen permeability). These are physical and chemical tests, not studies related to diagnostic accuracy or AI performance.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance in the context of an AI device and diagnostic accuracy.
2. Sample size for a test set or its provenance for an AI device.
3. Number of experts or their qualifications for establishing ground truth for an AI device.
4. Adjudication method for an AI test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human reader improvement with AI assistance.
6. Standalone performance of an algorithm (as there is no AI algorithm described).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI evaluation.
8. Sample size for a training set for an AI device.
9. How ground truth for a training set was established for an AI device.

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The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available as aspherical lenses manufactured by cast-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 Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with visible tint is light tinted blue using C.I Reactive Blue 246 to make the lens more visible for handling. The lenses also contain a UV absorber {2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate} which is included during the manufacturing process as an additive 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 380 nm. With more specific explanation, the "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens" 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 provided text describes the submission of a 510(k) premarket notification for the "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens." This notification aims to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove the device meets specific acceptance criteria as one might find for an AI/ML medical device.

Therefore, the requested information elements related to AI/ML device testing (sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or mentioned in this document. This submission focuses on the physical and chemical properties and biocompatibility of a contact lens compared to a predicate device.

Below, I've extracted the closest relevant information regarding "acceptance criteria" (which are generally product specifications and compliance with standards) and "reported device performance" based on the provided text.

Acceptance Criteria and Reported Device Performance for Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens

This submission establishes substantial equivalence for the Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens to a predicate device (Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens). The "acceptance criteria" are implied by the product specifications and compliance with various international standards for contact lenses, which were met by the device.

1. A table of acceptance criteria and the reported device performance

The document provides a comparison of specifications between the subject device and the predicate device. The "reported device performance" are the physical and chemical properties of the Unicon Hydrogel contact lens. The acceptance criteria are essentially that these properties, or test results, meet established standards and are substantially equivalent to the predicate.

• Biocompatibility tests: Complies with ISO 10993-1:2009, ISO 10993-2:2006, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, and ISO 10993-12:2012 for In Vitro Cytotoxicity, White Rabbit Ocular Irritation, and Acute Systemic Toxicity.
• Performance tests (Humectant, Water Content, Transmittance, Refractive Index, Oxygen Permeability, Mechanical Properties, Extractables of Material Pigment, Extractables, pH Value, Osmolarity, Geometric Parameters, Specific Gravity): Complies with ISO 18369-2:2012, ISO 18369-3:2017, ISO 18369-4:2017, ANSI Z80.20-2004, ASTM D882:2002, and ASTM D1708-13.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "A series of non-clinical studies were completed on this product." However, specific sample sizes for each test are not provided in this summary. The tests were performed according to FDA guidance "Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses, Issued May 1994" and related recognized consensus standards. Data provenance (country of origin, retrospective/prospective) is not specified for these non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a contact lens submission primarily based on physical, chemical, and biological compatibility testing, not diagnostic AI/ML requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML diagnostic 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. This is not an AI/ML diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML diagnostic device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on established scientific and engineering principles, and validated measurement methods as described by the cited ISO, ASTM, ANSI, and USP standards. For example, water content is measured physically, and biocompatibility is assessed through standardized biological tests.

8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The device is a manufactured product tested for its inherent properties.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.

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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.

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