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The Benz-G 4X 54% (Hioxifilcon D) Multifocal Lathed soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are myopic, hyperopic, possess astigmatism of 10.0 diopters or less and are presbyopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopter or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10 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.

The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lenses are hemispherical shells and are available as multifocal lens designs. The Benz-G 4X (Hioxifilcon D) Multifocal Lathed 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-linkned with ethylene glycol dimethacrylate (EGDMA). It consists of 46% Hioxifilcon Datod 54% water by weight when immersed in normal buffered saline solution buffered. 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, rransparent 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.

The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lens is substantially equivalent to the predicate device, the Benz-G 4X (Hioxifilcon D) Lathed Lens cleared under 510(k) K062854. The submission does not describe a study to prove acceptance criteria in the traditional sense of a clinical trial with a test set, ground truth, or statistical analysis. Instead, it relies on substantial equivalence to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device are implicitly established by demonstrating that its characteristics are substantially equivalent to those of the predicate device (Benz-G 4X Lathed Lens, K062854). The relevant "performance criteria" are the physical, chemical, and intended use specifications, which are compared side-by-side.

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

The submission states, "It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses." Therefore, there was no separate test set of subjects/data used for clinical evaluation of the new device. The data provenance would be inherent in the predicate device's original clearance.

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, as no new clinical study with a test set was conducted for the new device. The ground truth for the predicate device would have been established at the time of its clearance (K062854).

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

Not applicable, as no new clinical study with a test set was conducted for the new 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 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 concensus, pathology, outcomes data, etc)

Not applicable for a new clinical study. The basis of equivalence is the identical physical and chemical properties and manufacturing process to the predicate device, with an expanded intended use to include presbyopia.

8. The sample size for the training set

Not applicable, as no new clinical study was conducted.

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

Not applicable, as no new clinical study was conducted.

Study Proving Acceptance Criteria:

The study proving the acceptance criteria for the Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses is based on a side-by-side comparison testing with its predicate device, the Benz-G 4X (Hioxifilcon D) Lathed Lens (K062854).

The document explicitly states:

• "Side by side comparison testing was conducted on the Benz-G 4X (Hioxifilcon D) Lathed Lens already cleared under 510(k) K062854, and Multifocal Lenses manufactured by Benz Research & Development from Hioxifilcon D material."
• "This Benz-G 4X (Hioxifilcon D) material is identical to the previously cleared Benz-G 4X (Hioxifilcon D) under K062854."
• "The Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses have the identical manufacturing process (lathe-cut versus lathed-cut) as the marketed lens Benz-G 4X (Hioxifilcon D) Lathed."

The conclusion drawn from this comparison is that the new device is substantially equivalent to the predicate device in terms of:

• Intended use (with the addition of presbyopia correction)
• Materials
• Toxicological properties
• Physicochemical properties

The primary difference, an additional optical zone for multifocal correction, is presented as an enhancement to visual acuity correction rather than a fundamental change requiring new extensive clinical testing, given the identical base material and manufacturing process. The FDA's August 9, 2010 letter confirms this determination of substantial equivalence.

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The Benz-G 4X 54% (hioxifilcon D) soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased 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.

Benz-G 4X 54% (hioxifilcon D) lathed soft contact lenses are hemispherical shells and are available as spherical or toric lens designs. The Benz-G 4X 54% (hioxifilcon D) lathed 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% hioxifileon D and 54% water by weight when immersed in normal buffered saline solution buffered. 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.

The provided text describes a 510(k) premarket notification for a soft contact lens, the Benz-G 4X (hioxifilcon D) Lathed Sphere and Toric Lenses. The submission asserts substantial equivalence to a predicate device, Extreme H2O® 54% (hioxifilcon D) molded soft contact lens (K051430).

Based on the document, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a typical quantitative clinical trial sense (e.g., a specific sensitivity or specificity threshold). Instead, the substantial equivalence is based on a comparison of material properties, intended use, and non-clinical performance to a predicate device. The performance characteristics are compared as follows:

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

The document states, "It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Benz-G 4X (hioxifilcon D) lathed lens." Therefore, there is no "test set" in the context of a clinical trial with human subjects. The data provenance is from non-clinical testing (e.g., Agar Diffusion Test, Systemic Injection Test, Primary Ocular Irritation Test) performed in accordance with 21 CFR, Part 58. The specific number of samples for these tests is not provided, nor is the country of origin, though it's implied to be from the manufacturer's testing.

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

Not applicable. As clinical studies were not deemed necessary, there was no "ground truth" derived from human experts in a clinical setting. The non-clinical tests rely on standardized methodologies and interpretation by qualified laboratory personnel, rather than expert consensus on medical images or diagnoses.

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

Not applicable. There was no "test set" requiring adjudication by multiple readers or experts. The non-clinical tests have objective endpoints.

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 device is a soft contact lens, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

Not applicable. This device is a physical medical device (contact lens), not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" is derived from the objective results of the standardized biological and chemical tests. For example, in the Agar Diffusion Test, the absence of a zone of inhibition would be considered "non-cytotoxic," which is an objective observation rather than an interpretive "ground truth" from an expert. Similarly, for the systemic injection test, the "ground truth" comes from comparing biological reactions to control articles, and for ocular irritation, the "ground truth" is the observation of non-irritancy based on established criteria.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set." The manufacture of the contact lens relies on established materials and processes, not a machine learning model.

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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The 59% extreme H2O® (hioxifilcon A) soft contact lens for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The leas may be worn by persons who exhibit refractive astigmatism of .75 Diopters or less that does not interfere with visual acuity. The lens are available clear and with a blue visibility handling tint.

Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When presentbed for frequent/planned replacement wear, the lens may be disinfected using either a heat or chemical disinfection system.

The 59% extreme H2O® (hioxifilcon A) soft contact lens are hemispherical shells with molded sphencal base curves and molded from surfaces. The 59% extreme H100 soft contact lens are fabricated from (hioxifilcon A) which is a non-ionic ultra high molecular weight copolymer of 2-hydroxyethy) methacy wate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 41% hioxifilcon A and 59% water by weight when immersed in normal saline solution buttered with either sodium bicarbonate or sodium perborate. The lens is available in clear and 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The physical properties of the lens are:

The provided text is a 510(k) summary for a contact lens, focusing on a manufacturing process change rather than the development of an AI/ML device. Therefore, the questions related to AI/ML device performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable.

However, I can extract information related to the device's acceptance criteria and the study that proves it meets those criteria, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the requirement for "substantial equivalence" to the predicate device, specifically regarding physical, chemical, optical, and toxicological performance. The "reported device performance" are the values for the "cast-molded" lens which were found to be equivalent to the "lathe-cut" predicate.

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 does not explicitly state the sample size used for the "side by side comparison test results." It also does not specify the country of origin of the data or whether the study was retrospective or prospective.

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 not an AI/ML device requiring expert ground truth for classification. The "ground truth" for this device's performance is based on direct physical, chemical, and optical measurements.

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

Not applicable. This is not an AI/ML device. The comparison of physical and chemical properties would involve standard laboratory testing and measurements, not expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a contact lens, not an AI-assisted diagnostic device.

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

Not applicable. This is a physical device, not an algorithm.

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

The "ground truth" for establishing equivalence was the measured physical, chemical, and optical properties of the original "lathe-cut" 59% extreme H2O® contact lens. The "cast-molded" version was compared directly to these established properties.

8. The sample size for the training set

Not applicable. This is a contact lens undergoing a manufacturing process change, not an AI/ML model that requires a training set.

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

Not applicable. This is a contact lens undergoing a manufacturing process change, not an AI/ML model that requires a training set.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Side by side comparison test results." This study demonstrated that "the physical/chemical/optical and toxicological performance characteristics of the cast-molded contact lens are equivalent to the lathe-cut predicate device contact lens."

The core of the study was a direct comparison of the new "cast-molded" lens to the previously cleared "lathe-cut" lens across various specified properties (Refractive Index, Light Transmission, Water Content, Specific Gravity, Oxygen Permeability, and Toxicological Profile). The acceptance criterion was that the performance of the cast-molded lens should be equivalent to that of the lathe-cut predicate device. The document states that this equivalence was achieved, leading to the FDA's determination of substantial equivalence.

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The BENZ-G 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 and astigmatism of up to 0.75 Diopters where the astigmatism does not interfere with visual acuty. The lens may be disinfected with either a chemical or a heat disinfection system.

Benz-G 5X (hioxifilcon A) Hydrophilic Contact Lens for Daily Wear (clear and visibility tinted, lathe-cut)

This document is a 510(k) clearance letter for a contact lens, indicating substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria in the manner requested. The document describes the regulatory approval of a medical device (a contact lens) based on its equivalence to existing products rather than a performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

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The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens.

The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity.

The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction.

The lenses may be disinfected using chemical disinfection systems.

The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens.

The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity.

The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction.

The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve.

This non-ionic material is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid crosslinked with Ethylene Glycole Dimethacrylate, plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in normal buffered saline solution.

When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light rays on the retina.

Acceptance Criteria and Device Performance for BENZ Methafilcon A Contact Lenses

This document describes the acceptance criteria and the study that demonstrates the safety and effectiveness of BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses.

1. Acceptance Criteria and Reported Device Performance

The submission relies on demonstrating substantial equivalence to previously approved methafilcon A products. The acceptance criteria are implicitly based on meeting "normal limits" or being "within accepted limits" for various tests, consistent with established standards for Class II contact lenses and similar methafilcon A products already on the market.

2. Sample Sizes and Data Provenance

• Test Set (for physical testing):

  • "12 Lens Parameter Test": 200 lenses made from BENZ methafilcon A optical blanks.
  • "Burst Test": An entire batch of material (specific number not provided).
  • Data Provenance: The tests were run by a "recognized independent testing facility" and an "independent laboratory." No country of origin is explicitly stated, but the submission is to the FDA, implying conformity with U.S. regulatory standards. The data is retrospective, as the tests were completed prior to the 510(k) submission.

• Training Set: Not applicable in this context. The majority of the submission relies on physical and material testing, and reference to an already approved device (K950294) for finished lens performance and manufacturing controls, rather than machine learning models requiring training data.

3. Number and Qualifications of Experts for Ground Truth

• Not applicable for the reported pre-clinical and physical testing. The tests performed (e.g., irritation, injection, agar diffusion, burst test, lens parameter measurements) are objective laboratory measurements against defined standards, not human expert interpretation of subjective data.
• For the "Finished Lens Testing" section, the submission refers to the previously approved 510(k) K950294 for Flexlens 55 (methafilcon A) Soft Contact Lenses. It is implied that the original approval of K950294 would have involved appropriate expert evaluation during its review process; however, this submission does not detail those specifics.

4. Adjudication Method for the Test Set

• Not applicable. The tests are objective measurements with predefined "normal limits" or "within limits" criteria, not subjective interpretations requiring adjudication.

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

• No. This type of study is not relevant to the evaluation of contact lens material and physical properties as presented in this 510(k) notification. MRMC studies are typically used to assess the improvement in diagnostic accuracy or efficiency when human readers use AI-assisted tools for image interpretation.

6. Standalone (Algorithm Only) Performance Study

• No. This submission is for a medical device (contact lenses) and its material properties, not an algorithm or AI software. Therefore, an algorithm-only performance study is not applicable.

7. Type of Ground Truth Used

• Objective Laboratory Measurements and Established Standards:
  • Pre-Clinical Testing: Ground truth is established by "normal limits" for primary ocular irritation, systemic injection, and agar diffusion, which are standard toxicological and biocompatibility assessments.
  • Physical Testing: Ground truth is established by "normal limits" for physical properties determined through tests like the Burst Test and 12 Lens Parameter Test, likely against internal specifications or industry standards for contact lens manufacturing.
  • Finished Lens Testing: Ground truth is established by the methods, equipment, and manufacturing controls, along with the performance data (Microbiology, Solutions Compatibility, Shelf Life/Stability, Preservative Uptake/Release) detailed in the referenced and previously approved 510(k) K950294.

8. Sample Size for the Training Set

• Not applicable. This submission does not involve a machine learning model, and therefore, no training set was used.

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

• Not applicable. As there is no training set, there is no corresponding ground truth establishment method for it.

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The BENZ hefilcon A SPHERICAL Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The spherical lenses are available from +20.00 to -20.00 Diopters and may be worn by patients who can accomodate up to 1.5 Diopters of astigmatism.

The BENZ hefilcon A TORIC Soft (Hydrophilic) Contact Lenses in clear or with a light blue or light green visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The Toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction where it does not interefere with visual acuity.

The BENZ hefilcon A Spherical and Toric Contact lenses may be disinfected using either the heat (thermal) or the chemical (nonheat) disinfection system.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for contact lenses and does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device.

The document states that the BENZ Hefilcon A Soft (Hydrophilic) Daily Wear Contact Lenses are "substantially equivalent" to predicate devices, but it does not detail a study conducted to prove specific performance metrics against acceptance criteria. It focuses on regulatory clearance rather than a scientific study report.

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BENZ-G 3X Spherical (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic persons with with non-diseased eyes. The Spherical lenses are available from +20.00 to - 20.00 Diopters for persons who have up to 1.50 Diopters of astigmatism where the astagmatism does not interfare with visual acuity.

BENZ-G 3X Toric (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and/or non-aphakic The toric lenses are persons with with non-diseased eyes. available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction.

The material. BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermall or the chemical (not heat) disinfection system.

BENZ-G 3X (hioxifilcon B) Spherical or Toric is lathed into a soft (hydrophilic) contact lens which is a hemispherical shell. The non-ionic The Toric has a Toric Base Curve. material, hioxifilcon B is a copolymer of 2-hydroxyethyl methrylate (2-HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA). The copolymer consists of 52% BENZ-G 3X (hioxifilcon B) and 48% water by weight when immersed in normal saline solution buttered with sodium bicarbonate.

This document describes a 510(k) premarket notification for a contact lens, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific aspects like AI assistance, standalone algorithm performance, training/test set details, ground truth establishment methods, expert adjudication, and MRMC studies are not applicable.

The provided text focuses on the safety and effectiveness of the BENZ-G 3X (hioxifilcon B) contact lenses. However, it does not contain a table of acceptance criteria or the specific device performance values against those criteria that would typically be found in a clinical study report for an AI/ML device. It primarily details preclinical studies and general information about the device and its material.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The submission does not contain a defined table of acceptance criteria for performance metrics in the context of an AI/ML device, nor does it present device performance against such criteria. The document discusses "normal limits" for toxicology, microbiology, and biocompatibility, but these are not quantified acceptance criteria for an AI/ML model's output.

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

• Not Applicable. This is not an AI/ML study, so there is no "test set" in that context. The preclinical studies mentioned (toxicology, microbiology, biocompatibility, preservative uptake, lens stability) would have involved samples of the device or materials, but specific sample sizes for these tests are not provided in this summary. Data provenance is implied to be from internal BENZ Research and Development studies or contracted labs (Toxikon, ATCON, Metro Optics of Austin), but no country of origin is explicitly stated beyond "US" companies. The studies are prospective in the sense that they were conducted for this submission.

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

• Not Applicable. As there is no AI/ML test set, there is no ground truth established by experts in this context. The "truth" for preclinical tests would be defined by standard laboratory protocols and benchmarks (e.g., absence of toxicity, successful sterilization).

4. Adjudication method for the test set:

• Not Applicable. No AI/ML test set or expert adjudication is 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:

• Not Applicable. This is not an AI/ML 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 device.

7. The type of ground truth used:

• Not Applicable. For the preclinical studies (toxicology, microbiology, biocompatibility, etc.), the "ground truth" would be objective laboratory measurements and adherence to established scientific and regulatory standards (e.g., "within normal limits" for toxicology, successful sterilization validation). There's no interpretive "ground truth" like pathology or expert consensus.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device; there is no training set.

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

• Not Applicable. This is not an AI/ML device.

In summary, the provided document is a 510(k) summary for a physical contact lens and does not contain the type of information requested for an AI/ML medical device submission.

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