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Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 3.00 diopters or less, and are presbyopic. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Proclear UltraVue/D and Proclear UltraVue/N Multifocal (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity.

The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Daily wear replacement schedules may vary from patient and should be decided by the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.

Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are made of polymer of 2hydroxy-ethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge to edge for visibility purposes with the color additive C. I. Reactive Blue 4.

The front surface of the Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic. The Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric contact lenses are designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.

The Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are available in two versions. The Proclear UltraVue/D 2000T with a spherical central zone for the correction of distance vision and an aspherical annular zone for the correction of intermediate and near vision. The Proclear UltraVue/N 2000T with a spherical central zone for the correction of near vision and an aspherical annular zone for the correction of intermediate and distance vision.

Both lenses are a flexible transparent hemispherical shell of the following dimensions:

• Chord Diameter: 14.5 mm
• Center Thickness (minus): 0.15 mm to 0.20 mm
• Center Thickness (plus): 0.20 mm to 0.96 mm
• Base Curve: 8.3 mm to 8.9mm
• Spherical Powers: -20.00 D to +20.00 D
• Cylinder Powers: -0.75 to -2.75 D
• Add Powers: +1.00 to +3.50
• Central Zone Diameter: 2.3 mm to 2.6 mm (Proclear UltraVue/D 2000T), 1.7 mm to 2.0 mm (Proclear UltraVue/N 2000T)

The provided text describes a 510(k) premarket notification for CooperVision's Proclear UltraVue Multifocal and Multifocal Toric Soft (hydrophilic) Contact Lenses. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

The document is a regulatory submission for substantial equivalence to a legally marketed predicate device, focusing on device description, intended use, and material/design comparisons, rather than a clinical performance study with acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study that proves the device meets them based on the provided text. The requested information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not present in this document.

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The Resolution 5X (Spherical) (hioxifilcon A) 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 Ultra Gel 5X (Toric) (hioxifilcon A) 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/or possesses refractive astigmatism not exceeding 10 diopters.

The Resolution 5X (Spherical) and Ultra Gel 5X (Toric) (hioxifilcon A) Soft Daily Wear Contact Lenses are fabricated from hioxifilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon A) soft hydrophilic contact lens has a spherical back 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.

This document is a 510(k) summary for the Resolution 5X (Spherical) and Ultra Gel 5X (Toric) Hioxifilcon A Soft Daily Wear Contact Lenses. The submission asserts substantial equivalence to predicate devices rather than providing a study that establishes de novo acceptance criteria and demonstrates the device meets them.

Therefore, the following information is not applicable or not present in the provided text:

• Acceptance criteria table and reported device performance directly addressing those criteria.
• Sample sizes used for a test set, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size information.
• Standalone (algorithm-only) performance study.
• Type of ground truth used for a testing evaluation.
• Sample size for a training set.
• How ground truth for a training set was established.

This is a traditional 510(k) submission, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The primary evaluation here is a comparison to predicate devices, not a clinical trial establishing new performance criteria.

Here's a breakdown of the information that is present and relevant to the concept of demonstrating safety and effectiveness through substantial equivalence:

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

This specific table, as would be expected for a de novo submission or a clinical trial report, is not present. Instead, the document provides a "Substantial Equivalence Matrix" comparing the new device's characteristics to its predicate devices. The "acceptance criteria" are implicitly met if the new device's characteristics are similar enough to the predicate devices such that it does not raise new questions of safety and effectiveness.

Substantial Equivalence Matrix (Implicit "Acceptance Criteria" based on Predicate Devices):

Device Performance (from Device Description):

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

Not applicable. No separate "test set" for performance evaluation in the context of a new acceptance criterion is described, as this is a substantial equivalence submission. The pre-clinical toxicology and manufacturing/chemistry data were deemed equivalent to the predicate device (BENZ-G 5X, K952620), but details on those specific tests are not provided in this summary.

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.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 not an AI-assisted device.

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

Not applicable. This is not an algorithmic device.

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

Not applicable. Safety and effectiveness are demonstrated by substantial equivalence to predicate devices, drawing from their established safety profiles.

8. The sample size for the training set:

Not applicable.

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

Not applicable.

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The Resolution 45 (Spherical) (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves 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 Ultra Gel (Toric) (hioxifilcon B) 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/or possesses refractive astigmatism not exceeding 10 diopters.

The Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifileon B) Soft Daily Wear Contact Lenses are fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

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 (hioxifilcon B) soft hydrophilic contact lens has a spherical back 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 48% water by weight. The physical properties of the lens are:

Refractive Index: 1.515 (dry) 1.404 (hydrated)
Color Pigment Name: Phthalocyanine Blue
Light Transmission (clear): greater than 95% T
Light Transmission (tinted): greater than 95% T
Water Content: 48 % ±2%
Specific Gravity: 1.308 (dry) 1.136 (hydrated)
Oxygen Permeability: 15 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).

The provided summary for the Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Contact Lenses does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.

Therefore, many of the requested sections below cannot be populated from the provided text.

Here's an attempt to address the points based on the available information:

Acceptance Criteria and Device Performance Study (Information Not Provided)

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific acceptance criteria and the results of a study designed to prove the device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The submission relies on demonstrating similarity to predicate devices rather than presenting a performance study with a distinct test set.

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

• Number of experts: Not applicable, as a test set with expert-established ground truth is not described.
• Qualifications: Not applicable.

4. Adjudication method for the test set:

• Not applicable, as a test set requiring adjudication is not described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No MRMC comparative effectiveness study is mentioned in the provided text. The document is a 510(k) summary for a contact lens, which typically does not involve such studies for regulatory clearance.

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

• Not applicable. This device is a contact lens and does not involve an algorithm.

7. The type of ground truth used:

• Not applicable, as no specific performance study with ground truth is detailed. The submission relies on the established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set:

• Not applicable, as this device is a contact lens and does not involve a "training set" in the context of an algorithm.

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

• Not applicable.

Summary of Approach in the Document:

The provided document, a 510(k) summary, demonstrates substantial equivalence by comparing the new device (Resolution 45 and Ultra Gel contact lenses) to legally marketed predicate devices ("Horizon 55 Spherical & Westhin Toric" and "BENZ-G 3X"). This equivalence is established based on:

• Intended Use: The indications for use are similar.
• Design and Materials: The materials (hioxifilcon B, hydrophilic polymer), production method (lathe-cut), and physical properties (water content, polymer content, DK value, refractive index, specific gravity, light transmission) are compared and found to be similar or within acceptable ranges.
• Safety and Effectiveness Profile: The submission states that the established safety profile (preclinical toxicology and manufacturing/chemistry data) of the new device is equivalent to the BENZ-G 3X predicate.

Instead of a new performance study with defined acceptance criteria, the regulatory pathway relies on the known safety and effectiveness of the equivalent predicate devices.

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The UltraVue/P, UltraVue/C (hioxifilcon B) Soft (Multifocal) 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 may exhibit astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Ultra Vue/P, Ultra Vue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lenses are fabricated from hioxifilcon B. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. In the hydrated state, the lens conforms to the curvature of the eye covering the cornes and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifileon B) soft hydrophilic contact lens has a spherical back 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 wareed: 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 48% water by weight.

This submission is a 510(k) summary for the UltraVue/P, UltraVue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lens. It asserts substantial equivalence to predicate devices and focuses on material properties and manufacturing processes rather than a detailed clinical study demonstrating specific performance against acceptance criteria for a new clinical endpoint. Therefore, much of the requested information about clinical acceptance criteria and a study proving device performance against them is not explicitly available in the provided text.

Based on the provided text, the "acceptance criteria" are implied by the claim of substantial equivalence to existing predicate devices. The study proving the device meets these "acceptance criteria" is the demonstration of similar characteristics to those predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As specific performance "acceptance criteria" (e.g., visual acuity targets, comfort scores, etc.) are not presented in a quantitative manner in this substantial equivalence submission, the table below will reflect the comparison of physical and material characteristics to predicate devices, which serve as the implicit "acceptance criteria" for substantial equivalence.

Note: The "acceptance criteria" in this context are not quantitative performance thresholds from a clinical trial, but rather the demonstration that the new device's characteristics are sufficiently similar to those of legally marketed predicate devices to establish substantial equivalence.

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

The provided document describes a 510(k) premarket notification for substantial equivalence, not a clinical study with a "test set" in the sense of patient data. The "testing" referred to is primarily focused on material properties and manufacturing process equivalence, and pre-clinical toxicology.

• Sample Size for Test Set: Not applicable in the context of a clinical test set from this document. The "test set" here refers to the physical and chemical properties of the lens material itself, which would be tested on material samples, not a patient cohort. No specific numbers of samples for these material tests are given.
• Data Provenance: The document is a regulatory submission from a Canadian company (Opti-Center Laboratories) to the US FDA. The "pre-clinical toxicology and manufacturing/chemistry data" mentioned in the "Substantial Equivalence" section would originate from internal company testing or contract laboratories. The specific country of origin for these raw data is not stated, but the submission is for US market approval. The data is pre-marketing, so it would be considered prospective in relation to the submission date, but not "retrospective" clinical data.

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)

This information is not applicable and not provided in the document. This is a 510(k) submission for contact lenses, which relies on demonstrating equivalence through material science and design specifications, not expert-adjudicated clinical "ground truth" data for, for example, image interpretation or disease diagnosis.

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

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials, especially those involving expert interpretation of medical images or outcomes, to establish a consensus "ground truth." This document is a regulatory filing focused on substantial equivalence of a physical medical 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

This information is not applicable and not provided in the document. MRMC studies, especially those involving "AI assistance," are relevant for diagnostic imaging devices where human readers interpret medical images. This document is for soft contact lenses, which do not involve AI-assisted diagnostics or human 'readers' in that context.

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

This information is not applicable and not provided in the document. A standalone algorithm performance study is relevant for AI/ML-based diagnostic devices. This device is a contact lens.

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

The "ground truth" implicitly used for this device's "study" (i.e., the demonstration of substantial equivalence) is derived from established scientific understanding of material properties, manufacturing processes, and the performance of currently marketed predicate contact lenses.

• The "ground truth" for material properties (e.g., water content, DK value, refractive index) is based on standard scientific measurement techniques.
• The comparison to predicate devices serves as the "ground truth" for what constitutes "safe and effective" performance within this product category for the purpose of a 510(k). The regulatory assumption is that if the new device is sufficiently similar to a legally marketed predicate device, it shares its safety and effectiveness profile.

8. The sample size for the training set

This information is not applicable and not provided in the document. A "training set" refers to data used to train an algorithm, typically in machine learning or AI. This document pertains to a physical medical device (contact lens) and not an algorithmic system.

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

This information is not applicable and not provided in the document, as it relates to training data for algorithms, not a physical medical device.

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