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MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuty.

MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.

MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic persons with non-diseased eyes who may have -10.00 diopters of astigmatism or less.

AVAIRA VITALITY SPHERE and ASPHERE (fanfilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

A VAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eves in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with nondiseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.

Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear. When prescribed for frequent/planned replacement, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.

MyDay Contact Lenses are available as Asphere, Toric, Multifocal, and Multifocal Toric lens designs. The MyDay material, stenfilcon A, is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer, benzotriazolyl methacrylate, which is used to block UV radiation. When placed on the cornea in its hydrated state, the MyDay Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.

Avaira Vitality Contact Lenses are available as Sphere, Asphere, Toric, Multifocal, and Multifocal Toric lens designs. The Avaira Vitality material, fanfilcon A. is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer, benzotriazolyl methacrylate, which is used to block UV radiation. When placed on the cornea in its hydrated state, the Avaira Vitality Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.

The provided text describes a 510(k) premarket notification for two soft contact lenses: MyDay (stenfilcon A) and Avaira Vitality (fanfilcon A). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices, primarily due to a manufacturing process change and a change to the purity specification.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format with specific targets. Instead, it refers to "performance testing" conducted according to established standards. The reported device performance is presented as the results of these tests, which presumably align with the expectations of the referenced standards for substantial equivalence.

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

The document states that "non-clinical studies were provided in support of the substantial equivalence determination." However, it does not specify the sample sizes used for the test set for any of the performance tests.

Regarding data provenance, the studies were "conducted in accordance with the GLP regulation (21 CFR Part 58) or according to valid scientific protocols." This indicates that the data is from prospective studies designed to meet regulatory standards. The country of origin of the data is not specified, but given it's a US FDA submission, it's typically assumed to be generated in compliance with US regulatory frameworks.

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

This information is not applicable to the type of device and study described. The performance tests for contact lenses (contact angle, water content, mechanical properties, etc.) involve objective measurements rather than subjective expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are focused on objective physical and chemical properties of the contact lenses, which do not involve subjective interpretation or adjudication by multiple readers to establish ground truth.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images, and AI might assist in that interpretation. For contact lenses, the evaluation focuses on physical, chemical, and biological properties, not human interpretation of medical images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical medical device (contact lens), not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests on contact lenses is established through objective, standardized measurements according to the specified ANSI, ISO, and ASTM standards. For example, water content is measured using a defined gravimetric method, and mechanical properties are determined through tensile testing. For biocompatibility, chemical profiling (against ISO 10993-18:2020) was used to establish equivalence to the unmodified lenses (which presumably had established biocompatibility).

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires a training set. The studies described are traditional non-clinical performance and material characterization tests.

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

This information is not applicable as there is no training set for this device.

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Sphere/Asphere:

AVAIRA VITALITY SPHERE and ASPHERE (fanfilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Toric:

AVAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aplakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

Multifocal:

AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Multifocal Toric:

AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.

Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses fo frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.

The Avaira Vitality (fanfilcon A) Contact Lens visibility tinted with UV blocker is available as sphere/asphere lens, toric lens, multifocal lens, and multifocal toric lens.

The lenses are made of a silicone hydrogel material which is not surface treated and is characterized by high oxygen permeability (Dk). The Avaira Vitality (fanfilcon A) Contact Lens is tinted blue using Reactive Blue #246 to make the lens more visible for handling. A Norbloc UV blocker is used to reduce the amount of ultraviolet light transmitted into the eye. The Avaira Vitality (fanfilcon A) lens is supplied sterile, packaged in a phosphate buffered saline solution. The composition of the lens is 45% fanfilcon A and 55% water by weight when hydrated and stored in buffered saline solution.

In its hydrated state, the Avaira Vitality (fanfilcon A) Contact Lens visibility tinted, with UV blocker, when placed on the cornea, acts as a refracting medium to focus light rays on the retina.

The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:

• Diameter: 13.5 mm to 15.0 mm
• Base Curve: 8.2 mm to 9.2 mm
• Center Thickness: 0.06 mm to 0.6 mm (varies with power)
• Powers: -20.00 D to +20.00 D
• Cylinder Powers (Toric): -0.25 D to -10.00 D
• Axis (Toric): 0° to 180°
• Add Power Range (Multifocal) +0.25 D to +4.00 D

The physical/optical properties of the lenses are:

• Specific Gravity: 1.026
• Refractive Index: 1.398 ± 0.005
• Light Transmittance: 98% +2/-5%
• Surface Character: Hydrophilic
• Water Content: 55% ± 2%
• Oxygen Permeability: 90x10-11 [(cm²/sec) x (ml O2)/ (ml x mm Hg)]

This document is a 510(k) Premarket Notification from CooperVision, Inc. to the FDA regarding their Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (K213164).

Based on the provided text, the device in question is a contact lens, not an AI/ML powered device, therefore, many of the requested criteria are not applicable (N/A) or cannot be extracted from this document, as they pertain to the evaluation of AI/ML software performance.

Here's an analysis of the acceptance criteria and study information that can be extracted, and where the information is N/A:

Acceptance Criteria and Reported Device Performance

The document describes the device, its properties, and compares it to a legally marketed predicate device (K160803). The "performance data" section focuses on physical and optical properties rather than diagnostic performance metrics typically seen with AI/ML devices.

Study Details (Focusing on AI/ML Criteria - Mostly N/A for this device)

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

   • Not applicable (N/A). This document is for a physical medical device (contact lens), not an AI/ML software device that would require a "test set" of data in the context of algorithm evaluation. The document states, "The modification does not warrant performance testing to support substantial equivalence." This implies a lack of new clinical performance studies on the finished device in general.

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

   • Not applicable (N/A). No "ground truth" establishment in the context of diagnostic agreement is described for this physical device.

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

   • Not applicable (N/A). No adjudication method is necessary for a physical contact lens.

4. 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 (N/A). This is a contact lens, not an AI-assisted diagnostic tool.

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

   • Not applicable (N/A). This is a physical device, not an algorithm.

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

   • Not applicable (N/A). The evaluation for this device focuses on physical properties, material composition, manufacturing, and biocompatibility, not diagnostic 'ground truth.' The basis for substantial equivalence is primarily the identical material and manufacturing process to the predicate device, along with limited biocompatibility testing.

7. The sample size for the training set:

   • Not applicable (N/A). No AI/ML model for which a "training set" would be used is described.

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

   • Not applicable (N/A). No AI/ML model or training set is described.

Summary of the Study Proving Substantial Equivalence for the Contact Lens:

The submission for K213164 (Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens) is a 510(k) application for substantial equivalence to a predicate device (K160803), which is an earlier version of the same product.

The core of the "study" proving the device meets acceptance criteria for substantial equivalence relies on:

• Demonstrating Technological Characteristics are Identical: The subject device shares the exact same material (fanfilcon A), manufacturing method (Molded), sterilization method (Moist Heat), primary packaging, packaging solution, and visibility tint with the predicate device.
• Demonstrating Performance Specifications are Identical: Key physical and optical properties like water content, refractive index, specific gravity, oxygen permeability (Dk), base curve, and diameter are listed as "Same" as the predicate device.
• Limited Biocompatibility Testing: In accordance with GLP regulation (21 CFR Part 58), biocompatibility testing was performed on the lens and packaging solution, specifically:
  • ISO 10993-5:2009 (Tests for in vitro cytotoxicity)
  • ISO 10993-10:2010 (Tests for irritation and skin sensitization)
    The document states that "limited biocompatibility testing is adequate to support substantial equivalence" because the predicate device's lens material characteristics, primary packaging materials, and packaging solution are identical.
• Regulatory Basis: The 510(k) is submitted in accordance with the May 12, 1994 Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses. The modification (a "lens extract non-polymeric residuals specification change") was deemed by the submitter to not warrant performance testing to support substantial equivalence due to the fundamental similarities with the predicate.

In conclusion, for this specific medical device, the "acceptance criteria" revolve around demonstrating the device is fundamentally the same as a previously cleared device, supported by the specific physical and chemical properties and basic biocompatibility testing, rather than a clinical performance study with AI-specific metrics.

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Sphere/Asphere: AVAIRA VITALITY SPHERE and ASPHERE (fanfilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Toric: AVAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non- aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

Multifocal: AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Multifocal Toric: AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.

Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/ planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.

The AVAIRA VITALITY (fanfilcon A) Contact Lens visibility tinted with UV blocker is available as a sphere/asphere lens, toric lens, multifocal lens, and multifocal toric lens. The lenses are made of a silicone hydrogel material which is not surface treated and is characterized by high oxygen permeability (Dk). The AVAIRA VITALITY (fanfilcon A)) Contact Lens is tinted blue using Reactive Blue #246 to make the lens more visible for handling. A Norbloc UV blocker is used to reduce the amount of ultraviolet light transmitted into the eye. The AVAIRA VITALITY (fanfilcon A) lens is supplied sterile, packaged in a buffered saline solution. The composition of the lens is 45% fanfilcon A and 55% water by weight when hydrated and stored in buffered saline solution.

This document is a 510(k) premarket notification for a medical device (contact lenses), not an algorithm-driven AI/ML device. Therefore, the detailed requirements regarding AI/ML device acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable.

However, I can extract and structure the information related to the device's assessment for its intended purpose, which is proving substantial equivalence to predicate devices for contact lenses.

Here's an attempt to adapt the requested structure as much as possible, reinterpreting the questions for a non-AI/ML medical device context:

Device: Avaira Vitality (fanfilcon A) Soft (hydrophilic) Contact Lenses

1. Table of Acceptance Criteria and the Reported Device Performance

The concept of "acceptance criteria" for this contact lens is substantial equivalence to legally marketed predicate devices, meaning it is as safe and effective. The performance is assessed through non-clinical (material properties, toxicology, biocompatibility) and clinical testing.

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

• Sample Size for Clinical Study (Test Set): 90 subjects (60 subjects for Test lenses, 30 subjects for Control lenses).
• Data Provenance: A multi-center clinical study (exact geographic location not specified, but typically US-based for FDA submissions). The study was conducted retrospectively to collect the data from the clinical trial.

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

• This is not applicable in the context of a contact lens study seeking substantial equivalence. The "ground truth" for safety and efficacy in this clinical trial would be established by the clinical findings (e.g., slit lamp examinations, visual acuity measurements) as assessed by the participating clinical investigators/ophthalmic professionals, not by a multi-expert panel establishing a "ground truth" for diagnostic accuracy as for an AI/ML algorithm.

4. Adjudication Method for the Test Set

• Not explicitly described as an "adjudication method" in the AI/ML sense. The clinical study was a "randomized, masked, concurrent control study." This implies that the assessment of primary and secondary outcomes was done by investigators blinded to the lens type where possible, and comparisons were made between the test and control groups.

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, and no MRMC study or human-in-the-loop performance evaluation was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• In the context of this contact lens study, the "ground truth" for determining safety and efficacy was based on clinical outcomes data (e.g., slit lamp findings, adverse event rates, visual acuity measurements) observed in the study subjects. This data was collected by the clinical investigators involved in the multi-center trial.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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