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The Metro Soft, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes. 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 Metro Soft, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The Metro Soft, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Metro Soft, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Metro Soft, irregular cornea (efrofileon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

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

The Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lenses are fabricated from efrofilcon 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.

The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates RB246 (1,4-Bis[4-(2-Methacryloxyethyl) phenylamino]-9, 10-Anthraquinone)as an integrated handling tint. The lenses are made by lathe-cut for individual patients. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

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 (efrofilcon 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 74% water by weight. The lenses will be manufactured in spherical, aspherical, toric, multifocal, multifocal toric and irregular cornea configurations.

The lens is supplied sterile in vials containing a buffered saline solution.

Here's an analysis of the acceptance criteria and supporting studies for the Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A), based on the provided text:

Important Note: The provided document is a 510(k) summary for a contact lens. For medical devices like this, the "acceptance criteria" generally refer to established standards and benchmarks for safety and performance (e.g., ISO standards, physical property ranges), and the "study that proves the device meets the acceptance criteria" refers to the non-clinical and, if applicable, clinical testing performed to demonstrate compliance and substantial equivalence to a predicate device. This is different from the type of "acceptance criteria" and "study" typically associated with AI/ML-based diagnostic devices, which would involve metrics like sensitivity, specificity, AUC, and performance against a ground truth dataset.

Since this is a contact lens and not an AI/ML device, many of the requested fields regarding AI/ML-specific study design (test set sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Metro Soft contact lens are primarily defined by:

• Compliance with established ISO standards for biocompatibility and material properties.
• Meeting specified physical and optical parameter ranges with defined tolerances.
• Demonstrating similar performance characteristics (material properties, shelf life, solution compatibility) to the predicate devices.
• Having an equivalent Indications for Use statement to the predicate devices.

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The Metro Soft, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes. 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 Metro Soft, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The Metro Soft, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Metro Soft, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add nower of up to +4.00 diopters.

The Metro Soft, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

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 or hydrogen peroxide disinfection systems.

The Metro Soft Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon 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.

The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly bevond the limbus forming a colorless, transparent optical surface. The (efrofilcon 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 provided text describes a 510(k) summary submission for a medical device, the Metro Soft Silicone Hydrogel Daily Wear Soft Contact Lens. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing entirely new safety and effectiveness through extensive standalone clinical trials.

Therefore, the requested information about acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, or specific ground truth for an AI/algorithm-based device is not applicable to this document. This document details a regulatory submission for a contact lens, which is a physical device, and not an AI or algorithm.

Instead, the document outlines the following:

1. Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" in this context are the characteristics of the device that demonstrate its substantial equivalence to predicate devices. The performance is reported by direct comparison of its physical properties and intended use.

2. Study Proving Device Meets Acceptance Criteria:

The study that "proves the device meets the acceptance criteria" in this context is the comparison demonstrating substantial equivalence to legally marketed predicate devices. The document explicitly states:

• Clinical Data: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." This indicates that clinical studies were performed for the material in a prior submission (likely K100221 for IntelliWave3).
• Non-clinical Testing: "A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the Metro Soft (efrofilcon A) Silicone Hydrogel Soft Contact Lenses... All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols."
• Key Finding for Substantial Equivalence: "The Metro Soft, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is identical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221." And "The Metro Soft, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lenses have the identical manufacturing process (lathe-cut versus lathe-cut) as the marketed Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221."

No specific sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or training set details are provided because this is a 510(k) submission for a physical medical device, not an AI/ML algorithm requiring such specific performance validation methods. The "ground truth" for this submission relies on established safety and performance data of the predicate devices and general standards for biocompatibility and material properties of contact lenses.

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The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint may be prescribed for the corrective ametropia (myopia, hyperopia, and astigmatism) in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery.

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 RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint, which in the dry (unhydrated) state may be machined and polished to by cloud and prophilic nature of these materials 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 (hioxifileon B) soft hydrophilis 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 appar 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 49% water by weight. The physical properties of the lens are:

(Hioxifilcon B)

Refractive Index: 1.51 (dry) 1.42 (hydrated)
Light Transmission: greater than 94%
Surface Character: hydrophilic
Water Content: 49 %
Specific Gravity: 1.137 (hydrated)
Oxygen Permeability: 16.40 X 10 to the power of -11 (cm squared/sec) (ml O sub 2/ml x hPa @ 35 degrees C), (revised Fatt method)

This document is a 510(k) Premarket Notification for a medical device, specifically a soft contact lens. The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This process does not involve extensive clinical trials with acceptance criteria, ground truth, or statistical analyses in the same way a PMA (Premarket Approval) would.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this type of submission.

Instead, the submission focuses on demonstrating substantial equivalence based on material properties, intended use, and design similarity to existing predicate devices.

Here's what the document does provide, structured to address relevant aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the sense of predefined performance thresholds for a clinical study. Instead, it compares the new device's properties to existing, legally marketed predicate devices to establish substantial equivalence.

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The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in 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 SatureEyes II (acofilcon B) & (tetrafilcon 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 eves with myopia or hyperopia and may have astigmatism of 10.00 diopters or less where the astigmatism does not interfere with visual acuity.

The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eves with myopia or hyperopia and are presbyopic.

The SatureEyes II (acofilcon A), (acofilcon B) & (tetrafilcon A) Toric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes with myopia or hyperopia, have astigmatism of 10.00 diopters or less and are presbyopic.

Eyecare 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 disinfecting system.

The SatureEyes II Soft Contact Lens for Daily Wear is fabricated from (acofileon A), (acofilcon B) or (tetrafilcon 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 eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (acofilcon A), (acofilcon B) & (tetrafilcon A) soft hydrophilic contact lens 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 re-hydrated in the proper storage solution.

The non-ionic lens material, (acofilcon A), is a terpolymer based on high purity Glycerol Methacrylate2, 3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2 pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and crossed-linked with Diallyl Maleate (DAM). It consists of 42% acofilcon A and 58% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4'.

The non-ionic lens material, (acofilcon B), is a terpolymer based on high purity Glycerol Methacrylate2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2 pyrrolidone (NVP), methy) methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and crossed-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4'.

The non-ionic lens material, (tetrafilcon A), is a random terpolymer of 2-hydroxyethy) methacrylate, N-vinylpyrrolidone (NVP), methylmethacrylate (MMA), in a three dimensional network of terpolymer chains by divinylbenzene cross links. It consists of 58% (tetrafilcon A) and 42% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 163'.

This document describes the safety and effectiveness of the SatureEyes II contact lenses by demonstrating substantial equivalence to previously cleared predicate devices. The submission focuses on adding new materials (acofilcon A, acofilcon B, and tetrafilcon A) to an existing cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to predicate devices across various characteristics. The "reported device performance" refers to the physical properties of the new materials, which are compared to the predicate devices.

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

The document does not explicitly state a "test set" and its sample size in the context of device performance data collected for the SatureEyes II lenses themselves within this submission. Instead, the approach taken is demonstrating substantial equivalence to predicate devices, which implies that the predicate devices have already undergone sufficient testing.

The provenance of the data presented for the new materials (e.g., refractive index, water content, oxygen permeability) is not specified as "country of origin" or "retrospective/prospective." This data appears to be inherent physical properties of the materials themselves, likely determined through laboratory testing during material development.

Pre-clinical performance data for cytotoxicity, systemic injection, and ocular eye irritation are referenced in other 510(k) submissions (K023349 & K024045 for Contamac Ltd. and K954139 for CooperVisions), implying that these tests were conducted on the specific materials or similar materials by those companies. The details of those studies (sample size, provenance) are not provided here.

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

This type of information is not applicable to this submission. The "ground truth" for the device's performance is based on its physical properties and comparison to existing, legally marketed predicate devices, not on expert labeling of a dataset.

4. Adjudication Method for the Test Set

This is not applicable as there is no specific test set undergoing human review or adjudication mentioned in this document.

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 is not applicable. The device is a contact lens, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance is relevant.

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

This is not applicable. The device is a contact lens.

7. The Type of Ground Truth Used

The ground truth used for demonstrating substantial equivalence is:

• Physical and Chemical Properties: Laboratory measurements of material properties (water content, oxygen permeability, light transmission, refractive index, specific gravity) for the new materials.
• Established Performance of Predicate Devices: The known design, intended use, indications, and material properties of several already cleared contact lenses (MetroFocal Toric, Metro-G 55 (5X), Metro-G (3X)).
• Pre-clinical data: Referenced cytotoxicity, systemic injection, and ocular eye irritation tests from other 510(k) submissions. This suggests that the biological safety of the materials has been previously established or validated through these referenced tests.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of a machine learning algorithm for this medical device.

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

This is not applicable.

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The Comforthone™ Keratoconus Aspheric (patlufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical disinfection system.

The Comfort Kone" Keratoconus Aspheric Contact Lens is fabricated from the hydrophobic contact lens material (patfufocon C). The material is a thermoset copolymer derived from fluorosilicone acrylate When placed on the human cornea, the ComfortKone" Keratoconus Aspheric rigid gas monomer. permeable contact lenses act as a refracting medium to focus light rays upon the retina.

The ComfortKone" is a aspheric contact lens. It is designed to provide optimum comfort and visual acury to the keratoconus patient. The ComfortKone" lens design begins with a spherical 4,0 mm optic zone that fits the peak of the cone and provides for good visual acuity. The lens then the aspheric curve, which is considered the fitting curve of the lens. The aspheric curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. The design finishes with two junctionless peripheral aspheric curves to maintain alignment.

The provided document is a 510(k) premarket notification for a contact lens, the ComfortKone™ Keratoconus Aspheric (paflufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a novel technology. Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical trial for an AI/device with measurable performance metrics like sensitivity, specificity, or reader improvement.

Instead, the document demonstrates equivalence by comparing the new device's characteristics (production method, lens function, material properties) to those of a predicate device.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided in the requested format. The document does not specify "acceptance criteria" for performance metrics like sensitivity, specificity, etc., nor does it report "device performance" in that context. Instead, it compares specific characteristics of the new device to a predicate device to establish substantial equivalence.

  The closest we can get to showing "criteria" and "performance" here is by reproducing the "Substantial Equivalence Matrix" from the document, which serves as the fundamental comparison for acceptance:

The acceptance criterion applied here is the demonstration of "substantial equivalence" of these characteristics to the predicate device, which implies that the new device does not raise new questions of safety or effectiveness. The document explicitly states: "Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device."

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 document is a 510(k) premarket notification for a contact lens seeking substantial equivalence. It does not describe a clinical study with a "test set" of patients or data in the way an AI/software device would. The "data" here refers to the physical and chemical properties of the lens material.

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 / Not provided. There is no "ground truth" establishment by experts on a test set of data as this is a physical medical device (contact lens) seeking substantial equivalence based on material properties and design, not an AI or diagnostic algorithm.

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

• Not applicable / Not provided. As there is no test set or human interpretation involved, there is no adjudication method 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 / Not provided. This is not an AI-assisted device. Therefore, no MRMC study was conducted or is relevant to this submission.

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

• Not applicable / Not provided. This is a physical contact lens, not an algorithm or AI device.

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

• The "ground truth" in this context refers to the established physical and chemical properties of the new contact lens material and design, and the established safety and effectiveness profile of the predicate device. The document relies on:
  • Laboratory measurements of the new device's material properties (e.g., refractive index, light transmission, oxygen permeability, wetting angle, specific gravity, hardness).
  • The known performance and safety history of the predicate device (Rose K Lens, K945955).
  • Pre-clinical toxicology and manufacturing/chemistry data.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/ML device that requires a training set. The "development" of the device likely involved material science and engineering, not data-driven model training.

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

• Not applicable / Not provided. As there is no training set for an AI/ML model, this question does not apply.

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METRO-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 aphapic and/or non-aphakic persons with with non-diseased eyes. The Spherical lenses are available from +20.00 to - 20.00 Diopters for persons with up to1.50 Diopters of astigmatism where the astigmatism does not interfere with visual acuity.

METRO-G 3X Toric (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZETRO-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 nonaphakic persons with 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.

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

METRO-G 3X (hioxifilcon B) Spherical or Toric is lathed into a soft (hydrophilic) contact lens which is a hemispherical The Toric has a Toric Base Curve. The non-ionic shell . 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% METRO-G 3X (hioxifileon B) and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.

The lens METRO-G 3X (hioxifilcon B) is made from BENZ-G 3X (hioxifilcon B) optical buttons. When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light rays on the retina.

Due to the nature of the provided text, which appears to be regulatory submissions for a contact lens, the concept of "device performance" and "acceptance criteria" is not in terms of AI model metrics like sensitivity or specificity. Instead, it refers to the physical properties, safety, and compatibility of the contact lens. Therefore, the response will be tailored to this context, interpreting "acceptance criteria" as various tests and standards the contact lens had to meet for approval.

Here's an analysis based on the provided text:

Based on the provided text, the device is the METRO-G 3X (hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wear. The "acceptance criteria" and "device performance" are established through various pre-clinical studies to demonstrate the safety and effectiveness of the contact lenses.

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

2. Sample sized 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 sizes for the studies (e.g., toxicology, microbiology, lens stability, preservative uptake, extraction studies). It refers to "relevant studies," "in-house tests," and studies conducted by "Toxikon" and "ATCON."

• Data Provenance: The studies were conducted by specialized labs (Toxikon, ATCON) and by the developer of the polymer, as well as by Metro Optics of Austin, Inc. The location is implied by "Metro Optics of Austin, INC." in Pflugerville, TX, USA. The studies appear to be prospective in nature, as they were conducted specifically for the purpose of this 510(k) submission.

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)

The document does not specify the number or qualifications of experts involved in establishing the "ground truth" for the test sets. The "ground truth" here is less about expert consensus on interpretations and more about objective lab measurements and scientific assessments of material properties and biological responses. The studies were carried out by specialized testing facilities (Toxikon for toxicology, ATCON for preservative uptake) and the polymer developer, implying expertise in those fields.

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

The document does not describe any adjudication method in the context of expert review or consensus for the test results. The studies appear to rely on standard laboratory procedures and established scientific methods, with results interpreted against "normal limits" or industry standards.

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 such MRMC comparative effectiveness study was described. This is expected as the device is a contact lens, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

Not applicable. This 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.)

The "ground truth" for these studies is based on:

• Laboratory measurements and scientific standards: For toxicology, microbiology, lens stability, preservative uptake, and extraction studies. "Within normal limits" implies comparison against established safety and performance benchmarks.
• Material science characterization: For water content and chemical composition of the polymer.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable, as there is no training set for an AI model.

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The METRO FOCAL 38 ASPHERIC (polymacon) soft (hydrophilic) contact lenses for daily wear are available in clear and with a blue visibility tint. The lenses are indicated for visual acuity in non-aphakic patients with with non-diseased eves. The lenses are available in powers of -20.00 up to +10.00 Diopters of and up to 2.50 Diopters of add. These lenses will mask 2.00 Diopters of astigmatism where it does not interfere with visual aculty.

The METRO FOCAT 38 ASPHERIC (polymacon) soft (hydrophilic) contact lenses are lathe cut into an aspherical contact lens geometry which becomes a hemispherical shell. The polymer. polymacon was the first soft (hydrophilic) material and is one of the most frequently used polymers of HEMA at this time. Tt consists of 62% polymacon and 38% water by weight when fully hydrated in normal saline solution buffered with sodium bicarbonate.

The METRO FOCAT ASPHERTC (polymacon) soft (hydrophilic) contact lenses when hydrated and placed on the cornea acts as a refracting medium to focus light rays on the retina.

The provided text describes a 510(k) submission for a contact lens, the METRO FOCAL 38 ASPHERIC (polymacon) soft contact lens. This submission claims substantial equivalence to previously marketed devices. Therefore, the "study" conducted for this device is not a traditional clinical trial demonstrating de novo performance against acceptance criteria, but rather a demonstration of equivalence to existing, legally marketed devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not directly applicable in the traditional sense for this 510(k) submission. The document explicitly states: "This lens should be the equivalent of any other lens of aspheric configuration." and "Potential Safety and Effectiveness as well as Adverse Effects of the Device would be about the same as that of any other aspheric polymacon lens."

Instead of specific acceptance criteria for a new clinical study, the "acceptance criteria" are implied to be meeting the performance and safety profiles of existing, substantially equivalent aspheric polymacon contact lenses. The reported "device performance" is essentially a claim of equivalence.

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

• Sample Size: Not applicable as a separate "test set" in a traditional clinical trial sense. The submission relies on existing data for the polymacon polymer and the general performance of equivalent aspheric contact lenses.
• Data Provenance: The data provenance for the pre-clinical tests (toxicology, microbiology, compatibility, stability, preservative uptake) is stated as "another submission" or "in 1990" for the polymacon polymer. This indicates retrospective data analysis, likely from previous regulatory submissions for similar devices using the same polymer, rather than prospective data specifically generated for this new device. The clinical "data" is based on the general understanding and performance of 18 existing aspheric contact lens companies, 13 of which use polymacon.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Given that this is a 510(k) submission relying on equivalence, direct expert establishment of "ground truth" for a novel test set, as might occur in a diagnostic accuracy study, is not described. The "ground truth" is effectively the established safety and efficacy profile of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no specific "test set" and no "ground truth" established by experts in the context of a new clinical study requiring 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 device is a contact lens, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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" for this 510(k) submission is the established safety and effectiveness profile of legally marketed predicate devices, specifically other aspheric polymacon contact lenses. This is implicitly supported by:

• Pre-clinical safety data on the polymacon polymer gathered in prior submissions.
• The general understanding and performance of 18 existing companies producing aspheric contact lenses, 13 of which use the same polymacon polymer.
• The sponsor's claim that the new lens should be "equivalent" to these existing devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning model, so there is no "training set" in that context. The "training" in a broader sense would be the cumulative data and experience with contact lens manufacturing and the polymacon polymer over time, but not a specific dataset for algorithm training.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth establishment process for it.

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