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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 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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