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The Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear is indicated for daily wear use for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in non-aphakic persons.

The Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear is a lathe-cut soft lens multifocal with an aspheric front surface and a spherical base curve. In the dry (unhydrated) state the lens is machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The progressive optics utilize the simultaneous vision concept which offers functional vision from distance to near throughout the viewing range. The pupil zone on the front surface varies with the size of the patient's pupil.

The non-ionic lens material, hioxifileon A, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 41% hioxifilcon A and 59% water by weight. when immersed in normal saline solution buffered with sodium bicarbonate. Flexlens Multifocal Soft Contact Lenses for Daily Wear made out of hioxifilcon A are available in clear and with a blue visibility-handling tint, phthalocyanato (2) - (copper).

The non-ionic lens material, hioxifileon B, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 52% hioxifilcon B and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. FlexIens Multifocal Soft Contact Lenses for Daily Wear made out of hioxifilcon B are available in clear and with a blue visibility-handling tint, phthalocyanato (2) - (copper).

The provided document, K070308, is a 510(k) summary for the Flexlens Multifocal Soft Contact Lens (hioxifilcon A) and (hioxifilcon B) for Daily Wear. It clarifies that this is a premarket notification for a Class II medical device, and the FDA has determined it to be substantially equivalent to legally marketed predicate devices.

Crucially, this document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a de novo study with specific acceptance criteria and detailed performance data often seen in AI/algorithm-based device submissions.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not explicitly present in this 510(k) summary. The document primarily refers to "Pre-Clinical Performance Data" in previous 510(k) submissions for the materials themselves (hioxifilcon A and B).

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional contact lens submission, specific "acceptance criteria" and "device performance" metrics in the context of an AI/ML algorithm (e.g., sensitivity, specificity, AUC) are not described. Instead, the document focuses on the physical and optical properties of the lens materials.

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

This information is not provided in the 510(k) summary. The document references "Pre-Clinical Performance Data" in other 510(k) submissions (K983773 and K964528) for the hioxifilcon A and B materials, but it does not detail the specific studies, sample sizes, or data provenance conducted for this particular multifocal lens design.

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

This information is not provided in the 510(k) summary. It's not relevant for a traditional contact lens submission focused on physical/optical properties and chemical composition.

4. Adjudication method for the test set

This information is not provided and is not relevant for the type of device and submission 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

No, a MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic device, but a contact lens.

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

No, a standalone algorithm performance study was not done. This is not an AI/ML algorithm.

7. The type of ground truth used

The concept of "ground truth" as it applies to AI/ML diagnostics (e.g., pathology, outcomes data) is not applicable here. The "truth" for this device relates to its physical, chemical, and optical properties meeting established standards for contact lenses and being comparable to legally marketed predicate devices.

8. The sample size for the training set

This information is not provided and is not relevant as this is not an AI/ML device.

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

This information is not provided and is not relevant as this is not an AI/ML device.

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The Special Eyes 59 (hioxifilcon A) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.

The Special Eyes 49 (hioxifilcon B) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.

SpecialEyes 59 and 49 soft contact lenses are hemispherical shells available in spherical or toric lens designs and in. hioxifilcon A and hioxifilcon B materials.The lenses are fabricated by lathe cutting hioxifilcon A and hioxifilcon B materials both non-ionic copolymers of 2hydroxeyethylmethacrylate (2-HEMA) and Glycerol Methacrylate (GMA). The water content by weight is 49% for hioxifilcon B and 59% for hioxifilcon A. when immersed in normal saline. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent optical surface.

The provided text describes the 510(k) summary for the SpecialEyes 59 and SpecialEyes 49 Sphere and Toric soft contact lenses. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be directly extracted or inferred from this document.

Here's what can be gathered:

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

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., visual acuity improvement percentage, lens fit success rate) and subsequent reported device performance against those criteria. Instead, it relies on demonstrating adherence to manufacturing specifications and substantial equivalence to existing predicate devices.

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 mentions "Dimensional and verification testing has been completed" and "All product conformed to specification requirements." However, it does not specify the sample size used for this testing, nor does it provide details on the data provenance (country of origin, retrospective/prospective). This testing appears to be internal manufacturing quality control rather than a clinical trial.

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 or available in this submission. The "ground truth" here is adherence to manufacturing specifications, not a clinical assessment requiring expert consensus.

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

This information is not applicable or available in this submission. Adjudication methods are typically used in clinical studies involving interpretation, which is not the primary focus of this submission.

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

An MRMC comparative effectiveness study was not done. This submission is for contact lenses, which are not typically evaluated using MRMC studies, especially not in the context of AI assistance.

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

This information is not applicable. The device is a soft contact lens, not an algorithm.

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

The "ground truth" for this submission is based on manufacturing specifications and physical properties of the contact lenses (e.g., dimensions, material composition, water content). The document also extensively references substantial equivalence to predicate devices, implying that the performance and safety profiles of those previously cleared devices serve as an established baseline.

8. The sample size for the training set

This information is not applicable. The device is a physical product (contact lens), not an AI algorithm that requires a training set.

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

This information is not applicable. See point 8.

Summary of the Study:

The submission for SpecialEyes 59 and SpecialEyes 49 soft contact lenses is a 510(k) premarket notification. The "study" described is primarily preclinical testing focusing on dimensional and verification aspects to ensure the manufactured devices conform to specified requirements. The core argument for device acceptance is substantial equivalence to several predicate devices already cleared by the FDA (K983773, K964528, K042242, K981252, K953199, K964902).

The claim of substantial equivalence is based on the proposed device having an equivalent intended use, manufacturing materials, operating principles, and physical, operational, and biological specifications as compared to the predicate devices. Toxicological, microbiological, lens compatibility, preservation uptake, and shelf life studies were completed on the predicate device (K964528) and directly leveraged for this submission, indicating that new comprehensive studies for these aspects were not performed on the SpecialEyes lenses themselves, given their identical nature to the predicate.

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The Extreme H2O® 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Extreme H2O® 54% (hioxifilcon D) soft contact lenses are hemispherical shells and are available as spherical (G54 13.6 and G54 14.2) or toric (G54 Toric) lens designs. The Extreme H2O® 54% (hioxifilcon D) soft contact lens is fabricated from hioxifilcon D, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilcon D and 54% water by weight when immersed in normal saline solution buffered with either sodium bicarbonate or sodium borate. The lens is available with a blue visibility handling tint. phthalocyanato (2) - (copper).

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.

Here is the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Extreme H2O® 54% (hioxifilcon D) Soft Contact Lens for Daily Wear

1. Table of Acceptance Criteria and Reported Device Performance

The submission relies on a comparison to a predicate device (59% Extreme H2O® (hioxifilcon A) soft contact lens) and chemical/physical/toxicological testing to establish substantial equivalence. Direct "acceptance criteria" and "reported performance" for specific clinical outcomes are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" are implied by demonstrating that the new device's material properties fall within the range of, or are comparable to, already cleared materials and predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable in the context of a clinical study. The "test set" here refers to the new device (Extreme H2O® 54%), which underwent material characterization and toxicology testing.
• Data Provenance: The toxicology tests were performed on the Extreme H2O® 54% material (hioxifilcon D). The document implies these were standard ISO tests. The country of origin and whether the data was retrospective or prospective is not specified for these specific tests, but they are generally carried out prospectively as part of product development.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth, in the sense of expert consensus on clinical findings, was not established for this submission. The "ground truth" for the material properties and toxicology was based on established scientific and regulatory standards for material characterization and pre-clinical safety testing (e.g., ISO standards for toxicology).

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in the context of expert consensus or diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a contact lens, not an AI algorithm. Its performance is inherent to the physical and chemical properties of the lens, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission was based on:

• Material Characterization: Scientific measurements of properties like water content, refractive index, light transmission, specific gravity, and oxygen permeability.
• Toxicology Data: Results from standardized ISO safety tests (Systemic Injection Test, Agar Diffusion Test, Primary Ocular Irritation).
• Substantial Equivalence to Predicate Device: The established safety and effectiveness of the legally marketed predicate device(s) (59% Extreme H2O® (hioxifilcon A) and Benz-G 3X (hioxifilcon B)).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that uses a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia. Examples include, but are not limited to: adult and pediatric aphakia, and irregular astigmatism created by keratoconus, trauma, or post keratoplasty.

The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.

The lens may be disinfected with a chemical (not heat) disinfection system.

The Flexlens and Harrison Post Refractive Surgery (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) is fabricated from one of the above materials 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 eve 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 provided text describes a 510(k) submission for new contact lens materials, not a study proving device performance against acceptance criteria in the typical sense of a clinical or AI performance study. The submission focuses on demonstrating substantial equivalence to predicate devices. Therefore, many of the requested categories are not applicable to this type of regulatory submission.

Here's a breakdown of the relevant and non-applicable information based on the provided text:

Acceptance Criteria and Device Performance

The "acceptance criteria" in this context are the characteristics and performance values that demonstrate substantial equivalence to legally marketed predicate contact lenses. The device performance is assessed by comparing these characteristics of the new materials to those of the predicate materials.

*Note: Oxygen Permeability units are (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).

Study Details Table

This submission is a 510(k) Pre-Market Notification for substantial equivalence for new materials for an existing device, not a performance study (e.g., clinical trial) in the traditional sense that would generate new patient-specific data for acceptance criteria. The "study" here is primarily a comparison of material properties and intended uses to predicate devices.

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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 OXYLENS (hioxifilcon B) 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 byperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters of less where the astigmatism does not interfere with visual acuity.

The OXYLENS (hioxifileon B) 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/or possesses refractive astigmatism not exceeding 10 Diopters.

The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.

The OXYLENS (bioxifilcon B) Soft (Spherical & Toric) 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 eve. 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.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Oxylens:

Based on the provided 510(k) summary, the device (Oxylens soft contact lenses) is seeking substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria for device performance in a clinical trial. The "acceptance criteria" here refer to demonstrating that the Oxylens device is functionally and materially equivalent to already-approved devices, meaning it meets the same safety and effectiveness profile.

The document primarily focuses on demonstrating equivalence through comparison of physical properties and manufacturing methods, rather than presenting a clinical study with performance metrics like sensitivity, specificity, or reader improvement.

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

Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the characteristics of the predicate devices. The device "performance" is the Oxylens' material and manufacturing properties matching or being similar to those of the predicate.

Study that proves the device meets the acceptance criteria:

The "study" proving equivalence is a comparison of the physical, chemical, and manufacturing characteristics of the Oxylens with those of the identified predicate devices ("Alden Classic" series, "Satureyes" and "Satureyes Toric" manufactured by Metro Optics, and "BENZ-G 3X" manufactured by Benz Research and Development). The document explicitly states: "The following matrix illustrates that the production method, lens function and material of the OxyLens (hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathecut from Lens Blank), are substantially equivalent to the predicate device(s). In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device."

This is a technical and material comparison, not a clinical efficacy or safety trial in the typical sense. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 3X (hioxifilcon B), 510(k) #K964528.

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

• Sample Size for Test Set: Not applicable. This submission relies on material and manufacturing equivalency testing and existing data from predicate devices, not on a new clinical test set of patients or images.
• Data Provenance: The data provided relates to the physical and chemical properties of the lens material. The "established safety profile" is linked to a predicate device (BENZ-G 3X) which would have undergone its own review. The provenance of that underlying data is not detailed here. It is not a clinical study with patient data provenance.

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 submission does not involve expert review for a "test set ground truth" in the context of an AI or diagnostic device. The ground truth for material properties is established through standard laboratory testing.

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

• Not applicable. There is no clinical "test set" and thus no adjudication method for establishing ground truth from multiple readers/experts.

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

• No MRMC clinical study was done. This device is a contact lens, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a contact lens, not an algorithm.

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

• The "ground truth" here is based on standard material science properties and manufacturing characteristics (e.g., water content, Dk value, refractive index) as determined by established laboratory methods, and the functional characteristics of existing, legally marketed contact lenses. This is a technical equivalency, not a medical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

• Not applicable. This submission does not involve machine learning or an AI algorithm, so there is no training set.

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

• Not applicable, as there is no training set.

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