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The AQUASOFT ALL-DAY (hioxifilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.

The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The AQUASOFT ALL-DAY T (hioxifilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (hioxifilcon A) is a random copolymer of 2-hydroxythyl methacrylate and 2,3 -dihydroxypropyl methacrylate, cross linked with ethylene glycol dimethacrylate. It consists of 43% hioxifilcon A and 57% water by weight when immersed in sodium carbonate buffered saline solution. The lens is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.2121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 57% water by weight.

This 510(k) summary describes a new contact lens device, the AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Daily Wear Contact Lens, and compares it to predicate devices to establish substantial equivalence. The document primarily focuses on demonstrating that the new device shares similar technological characteristics and intended use with existing legally marketed devices.

However, it does not contain information related to a study proving the device meets specific acceptance criteria in the way described by the user's detailed request. The 510(k) summary is for a medical device (contact lens), and its demonstration of safety and effectiveness typically relies on comparing its physical and chemical properties and intended use to predicate devices, rather than a clinical study with performance metrics in the context of AI/diagnostic devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Based on the provided text, here is what can be extracted and what cannot:

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

The document provides a comparison of technological characteristics between the new device and predicate devices. These characteristics serve as the basis for establishing substantial equivalence, indicating that the new device performs similarly to the predicates. While not explicitly "acceptance criteria" in a traditional diagnostic study sense, these are the properties that must be substantially equivalent.

Regarding the study that proves the device meets the acceptance criteria:

The document describes a 510(k) submission, which relies on demonstrating substantial equivalence to legally marketed predicate devices. This is not a study in the sense of a clinical trial designed to measure performance against a specific set of acceptance criteria for diagnostic output or treatment efficacy. Instead, it's a submission of data (physical properties, chemical composition, intended use, manufacturing method) that shows the new device is as safe and effective as a predicate device.

Specifically, the "study" mentioned is the comparison of the new device's technological characteristics to those of three predicate devices. This comparison (Table #1) is the core evidence presented.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable/Not provided. This type of information is typically not included in a 510(k) submission for a contact lens, as it's not a diagnostic device with a "test set" of patient data for performance evaluation in the requested manner. The "data" here refers to the device's physical and chemical properties.

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

• Not applicable/Not provided. This concept of "ground truth" and expert adjudication is relevant for diagnostic devices or AI algorithms evaluating medical images/data, not for the physical properties of a contact lens.

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

• Not applicable/Not provided.

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/Not provided. The device is a contact lens, not an AI-powered diagnostic tool.

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

• Not applicable/Not provided. The device is a contact lens, not an algorithm.

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

• Not applicable/Not provided. The "ground truth" for a contact lens's performance is its physical and chemical properties and its ability to correct vision, which is evaluated through refractive measurements and observation during eye care professional fittings, not through pathology or outcomes data in the context of a diagnostic test.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" in the context of a contact lens 510(k) submission.

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

• Not applicable/Not provided.

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The AQUASOFT (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The AQUASOFT (ocufilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The AOUASOFT (ocufilcon D) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D.

The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Eyecare practitioners may prescribe the lenses for daily wear for disposal after removal in a disposable lens program or for cleaning, disinfection and scheduled replacement in a frequent replacement program. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The AQUASOFT (ocufilcon D) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, aspherical multifocal lens and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The ionic lens material. (ocufilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in normal buffered saline solution. The lens polymer contains a UV absorbing compound and is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.2121. The ocufilcon D name has been adopted by the United States Adopted Names Council (USAN).

In the AQUASOFT Contact Lens with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV blocking for AQUASOFT averages > 99% in the UVB range of 280nm -315nm and 83% in the UVA range of 316 - 380mm.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 55% water by weight.

The provided 510(k) summary describes the AQUASOFT (ocufilcon D) Daily Wear Contact Lens. This document indicates that no clinical studies were required or performed to demonstrate substantial equivalence for this device. Instead, the submission relies on non-clinical performance data and a comparison of technological characteristics to a predicate device.

Therefore, the following information is not present in the document:

• Acceptance criteria in the context of a clinical study
• Study proving device meets acceptance criteria (as no clinical study was done)
• Sample size for the test set
• Data provenance
• Number of experts used to establish ground truth
• Qualifications of experts
• Adjudication method
• MRMC comparative effectiveness study or effect size
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

However, I can provide the technological characteristics comparison table which serves as the "performance" data for demonstrating substantial equivalence based on pre-clinical information.

1. Table of Key Technological Characteristics (Acceptance Criteria are inferred from equivalence to predicate device)

The device demonstrates substantial equivalence by matching or being comparable to the predicate device across these characteristics. Any significant deviation would require further justification or clinical data.

Summary of the Study (Demonstration of Substantial Equivalence):

The "study" in this context is a pre-clinical comparison of the AQUASOFT lens to a legally marketed predicate device (BIOMEDICS 55) to demonstrate substantial equivalence, rather than a clinical trial with specific acceptance criteria.

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

• Sample size for test set: Not applicable, as no clinical test set was used. The evaluation was based on a comparison of device characteristics and non-clinical laboratory testing.
• Data provenance: Not explicitly stated for specific test data, but the submission is from ClearLab PTE, Ltd. (Singapore) and 1800 CONTACTS, Inc. (USA). The non-clinical tests were conducted as recommended by the FDA guidance document for Daily Wear Contact Lenses.

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

• Not applicable, as no clinical test set requiring expert ground truth was performed or discussed in this summary.

4. Adjudication method for the test set:

• Not applicable, as no clinical 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, as this is a contact lens device (not an AI medical imaging device) and no clinical studies were performed.

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

• Not applicable, as this is a contact lens device (not an AI algorithm).

7. The type of ground truth used:

• Not applicable directly to a clinical test set. For the non-clinical tests (e.g., toxicology, physiochemical properties), the "ground truth" would be established by industry standards, validated laboratory methods, and regulatory guidelines for contact lens materials.

8. The sample size for the training set:

• Not applicable, as there is no "training set" in the context of an AI/machine learning device.

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

• Not applicable.

Conclusion from the document:

The submission concludes that the AQUASOFT Soft Contact Lens is substantially equivalent to the predicate device(s) based on the presented technological characteristics and non-clinical testing, and "does not raise different questions of safety and effectiveness than that of the predicate devices." No clinical data was required or submitted for this 510(k) premarket notification.

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The MIERU (etafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The MIERU (etafilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D or less.

The MIERU (etafilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The MIERU (etafilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, aspherical multifocal lens and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The ionic lens material, (etafilcon A) is a co-polymer of 2- hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1 - trimethylol propane trimethacrylate glycol demethacrylate. It consists of 42% etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer contains a UV absorbing compound and is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.3121. The (etafilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the MIERU Contact Lens with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV blocking for MIERU averages > 99% in the UVB range of 280nm - 315nm and 83% in the UVA range of 316 - 380nm.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out. it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are: Refractive Index 1.4050 (wet), Light Transmission (clear) greater than 95%, Light Transmission (tinted) greater than 91%, Water Content 58 %, Specific Gravity 1.017 (hydrated), Oxygen Permeability 19.9 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).

Here's a breakdown of the acceptance criteria and study information for the MIERU (etafilcon A) Daily Wear Contact Lens, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

This 510(k) submission doesn't explicitly state "acceptance criteria" in terms of performance metrics like sensitivity or specificity. Instead, the study focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and non-clinical testing. The acceptance criteria are implicitly met if the new device's properties are comparable to or within acceptable ranges of the predicate devices.

Here's a table summarizing the key technological characteristics considered for equivalence:

Summary of Non-Clinical Performance Data (Used to demonstrate equivalence):

The device underwent the following non-clinical tests as recommended by the Premarket Notification 510(k) guidance document for Daily Wear Contact Lenses, revised May 1994:

• Toxicology testing:
  • Cytotoxicity
  • USP Ocular Irritation
  • USP Systemic Injection
• Leachability / Residual monomer Studies
• Physicochemical property testing

The conclusion drawn from these studies was that the MIERU Soft Contact Lens is substantially equivalent to the predicate devices and does not raise different questions of safety and effectiveness.

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical trials. The data presented for the new device (ClearLab800 etafilcon A) are physical and chemical properties derived from laboratory testing of the device itself.
   • Data Provenance: The data refers to the characteristics of the device (ClearLab800 (etafilcon A)) itself, rather than test data from patients. The origin of the raw materials for manufacturing is not specified, nor is there a mention of specific countries for testing. This is a non-clinical submission, not a clinical trial. The data is prospective in the sense that these properties were measured on the newly developed device.

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

   • Not applicable (N/A). This submission relies on non-clinical data (physical and chemical properties, toxicology) to demonstrate substantial equivalence to predicate devices, not on expert-adjudicated clinical outcomes for a "ground truth." The "ground truth" here is the established safety and effectiveness of the predicate devices based on their own prior approvals and the standardized methods used for material characterization and toxicology.

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

   • None. As there's no clinical test set requiring expert adjudication for a diagnosis or outcome, no adjudication method was used.

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:

   • No. This is not an AI/CAD device. It is a contact lens. Therefore, no MRMC study was performed, and this question is not applicable.

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

   • Yes, in essence. The "device performance" in this context refers to the inherent physical and chemical properties of the contact lens itself, measured directly in a laboratory setting, independent of human interaction or a human-in-the-loop scenario. The non-clinical tests (toxicology, leachability, physicochemical properties) are standalone assessments of the device's characteristics.

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

   • The "ground truth" in this submission is indirectly established by the legally marketed predicate devices and the objective measurements of the new device's physical, chemical, and biological properties through standardized laboratory testing (e.g., water content, oxygen permeability, specific gravity, toxicology tests). The concept of "ground truth" derived from expert consensus or pathology, as typically used in AI/CAD imaging, does not apply here. The benchmark is the established safety and performance profile of the predicate devices.

7. The sample size for the training set:

   • Not applicable (N/A). This is a submission for a medical device (contact lens), not an AI algorithm requiring a training set.

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

   • Not applicable (N/A). As stated above, this is not an AI algorithm, so there is no training set or associated ground truth establishment process in that context.

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