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The Definitive, Flexlens, 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 non-diseased 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 Definitive, Flexlens, 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 Definitive, Flexlens, 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 eves and/or possesses refractive astigmatism not exceeding . 75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Definitive, Flextens, 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 Definitive, Flexlens, 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 Definitive, Flexlens 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 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

Acceptance Criteria and Study Findings for Definitive, Flexlens - Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

This document describes the acceptance criteria and the study that demonstrated the Definitive, Flexlens - Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) meets these criteria, based on the provided 510(k) summary (K100443).

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are primarily established by its substantial equivalence to predicate devices, meaning its physical properties, intended use, and safety/effectiveness are comparable. The study did not define explicit numerical acceptance criteria for clinical performance but focused on demonstrating equivalence.

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

• Sample Size: Not applicable for clinical testing of the current device. The document explicitly states: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." The current submission relies on the established performance of the material (efrofilcon A) which is part of the predicate device "Intelliwave³ (efrofilcon A)" (K100221).
• Data Provenance: Not specified for the historical clinical data related to the efrofilcon A material. However, all non-clinical toxicity and biocompatibility tests for the current device were conducted in accordance with GLP (Good Laboratory Practice) regulations, implying controlled laboratory settings rather than human subject testing in the context of this specific 510(k). The non-clinical data is prospective as it was specifically performed for this submission. The country of origin is not specified.

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

Not applicable. No new clinical studies were conducted for this 510(k) submission, and therefore no "experts" were used to establish a ground truth for a test set in the context of a new clinical evaluation. The ground truth for safety and effectiveness is established by the previous clearance of the predicate device (Intelliwave³ efrofilcon A) and the inherent properties of the efrofilcon A material.

4. Adjudication Method for the Test Set

Not applicable. No new clinical test set requiring adjudication was used in this 510(k) submission.

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

Not applicable. This was not a diagnostic device involving a multi-reader multi-case (MRMC) study. The device is a contact lens, and its effectiveness is determined by its physical properties, biocompatibility, and functional equivalence to legally marketed predicate devices.

6. Standalone Performance Study

A standalone performance study for the clinical effectiveness of the algorithm (device) was not explicitly conducted as part of this 510(k) submission. The submission relies on the established clinical performance of the efrofilcon A lens material from prior clearances.

However, various non-clinical (in vitro and in vivo preclinical toxicology and biocompatibility) tests were performed on the Definitive, Flexlens device in a standalone manner to assess its safety. These tests assessed:

• Sterility
• Packaging material and extract toxicity/irritation
• Lens physical and material properties

7. Type of Ground Truth Used

The "ground truth" for the device's safety and effectiveness in this 510(k) is based on:

• Substantial Equivalence: The primary ground truth is the established safety and effectiveness of the predicate devices, particularly the "IntelliWave', Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" (K100221), to which the new device is stated to be identical in material and manufacturing process.
• Non-clinical Testing: Laboratory testing (toxicology, biocompatibility, sterility, shelf-life) performed according to GLP regulations and valid scientific protocols provided ground truth for these specific safety aspects.
• Previously Established Clinical Performance: The document states, "The clinical performance of the (efrofilcon A) lens material has been previously established," indicating reliance on prior clinical data for the material itself.

8. Sample Size for the Training Set

Not applicable. This device is a medical device (contact lens), not an AI/ML algorithm that requires a "training set" in the computational sense. The manufacturing process does not involve machine learning.

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

Not applicable, as there is no "training set" for this type of device.

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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 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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