Search Results

• Sphere and Asphere
  Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Sphere and Asphere designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

• Toric
  Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.50 to -3.50 diopters.

• Multifocal
  Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

The lenses are intended for single-use disposable wear.

The Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses are visibility-tinted and include UV blocker-containing materials. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tinted with "Reactive Blue 19", "Reactive Red 180", and "Reactive Yellow 15", which are approved color additives by the U.S. FDA and listed in 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).

N/A

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Sphere/ Asphere
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D

Toric
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D and astigmatic corrections from -0.25D to -3.50D.

Multifocal
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) with presbyopia in aphakic or non-aphakic person with non-diseased eyes who may have +0.25D to +3.00D of ADD powers or less. The lens may be prescribed in spherical powers ranging from +6.00D to -12.25D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.

Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are clear and visibility tint with UV blocker are available as a spherical lens. The lens material, Toufilcon B is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA), N-Vinyl-2-Pyrrolidinone (NVP), N,N-Dimethylcarylamide (DMA), Methacrylic Acid (MAA), (3-Methacryloxy-2-hydroxypropoxy)propyl-bis(trimethylsiloxy)methylsilane (SiGMA) and Polydimethylsiloxane macromer (monofunctional Polydimethylsiloxane) (PDMS macromer), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and
Triallyl isocyanurate (TAIC) via photo-polymerization. The copolymer consists 50% Toufilcon B and 50% water by weight when immersed in buffered borate solution. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Toufilcon B name has been adopted by the United States Adopted Names Council (USAN).

This document describes the regulatory clearance of contact lenses, not a medical AI device requiring the kind of rigorous AI-specific validation outlined in your request. The provided text is a 510(k) clearance letter for contact lenses, which focuses on demonstrating substantial equivalence to a predicate device through physicochemical, biocompatibility, and clinical performance in human subjects, rather than AI model performance metrics.

Therefore, many of the requested elements for an AI device's acceptance criteria and accompanying study (e.g., sample size for test set, data provenance for AI, number of experts for ground truth, adjudication method, MRMC studies, standalone AI performance, training set details) are not applicable to this document as it does not relate to an AI device.

However, I can extract the relevant information from the provided document concerning the contact lens study and present it in a similar structured format, adapting where necessary.

Device: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

Nature of Study: Clinical trial demonstrating substantial equivalence of a new contact lens product to an existing predicate device, focusing on safety and effectiveness for vision correction. This is not an AI device study.

1. Table of Acceptance Criteria (for Contact Lenses) and Reported Device Performance

Given this is a contact lens, the "acceptance criteria" are related to clinical efficacy (visual acuity) and safety (adverse events, slit lamp findings), and various physicochemical properties. The study aims to show non-inferiority or comparability to the predicate device rather than meeting specific numerical thresholds for many of the elements you'd expect in an AI performance table (e.g., sensitivity, specificity).

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

• Test Set Sample Size:
  • Screened: 75 subjects
  • Enrolled: 56 subjects (39 wore test lenses, 17 wore control lenses)
  • Completed Study: 54 subjects (2 subjects in test group discontinued)
• Data Provenance: Prospective, randomized, double-blind, parallel, active-controlled clinical trial conducted in Taiwan.

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

Not explicitly stated for establishing "ground truth," as this was a clinical trial involving patient outcomes and examinations. Clinical assessments were likely performed by eye care professionals involved in the study (e.g., ophthalmologists, optometrists), but a specific number or their detailed qualifications are not provided in the summary. The "ground truth" for contact lenses is physiological response, visual acuity, and safety outcomes from direct patient observation.

4. Adjudication Method for the Test Set

Not explicitly stated. Clinical trials typically have protocols for adverse event reporting and assessment, often by an independent safety committee or study investigators.

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

No, an MRMC study was not done. This type of study is specifically designed for evaluating diagnostic performance of imaging modalities or AI systems where multiple readers interpret cases. This document describes a clinical trial for a contact lens, comparing direct patient outcomes between a new lens and a predicate.

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

The "ground truth" for this contact lens study was based on:

• Clinical Outcomes Data: Corrected visual acuity measurements.
• Safety Data: Adverse event reporting, assessment of slit lamp findings (direct observation of ocular health by clinicians).
• Physicochemical and Biocompatibility Test Results: Objective laboratory measurements demonstrating material properties and biological safety.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning study, so there is no training set in that context. The "training" for the device would be the manufacturing process and quality control.

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

Not Applicable. See point 8.

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Sphere and Asphere
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Sphere designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with nondiseased eyes in powers from +6.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

Toric
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Toric designs are indicated for the correction of refractive ametropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.50 to -3.50 diopters.

Multifocal
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

The lenses are intended for single-use disposable wear.

The Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses are visibility-tinted and include UV blocker-containing. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tinted with "Reactive Blue 19" and "Reactive Red 180" color additive, 21 CFR part 73.3121. Besides, Reactive Yellow 15, 21 CFR part 73.3121, is also used to reduce light in the range from 380 nm to 450 mm. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The lens reduces transmittance by less than or equal to 35% in the light range from 380 nm to 450 nm.

The provided text describes a 510(k) submission for Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses. It outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of a diagnostic or AI-powered medical device.

This submission is for soft contact lenses, which are regulated differently from diagnostic software/AI. The "studies" mentioned are non-clinical performance and biocompatibility tests, not clinical performance studies with acceptance criteria for diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC).

Therefore, I cannot fulfill your request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone studies, because this information is not present in the provided FDA 510(k) summary for a contact lens.

The document mainly focuses on:

• Technological characteristics comparison to a predicate device (K222885).
• Non-clinical testing (physicochemical properties, biocompatibility, shelf life, sterility) to demonstrate safety and effectiveness for a contact lens.
• Substantial equivalence based on material, design, intended use, and performance claims to the predicate device, with differences in dye and light transmittance being compared to another reference device (ACUVUE® OASYS MAX 1-DAY K210930).

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Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Sphere and Asphere designs are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Toric designs are indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/ or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

The lenses are intended for single-use disposable wear.

The Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).

The provided document (K222885) is a 510(k) Premarket Notification for contact lenses, specifically Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water).

It is crucial to understand that this document describes a submission for a medical device (contact lenses), NOT an AI/ML-powered diagnostic device. Therefore, the standard acceptance criteria and study designs typically associated with AI/ML systems (such as those involving test sets, ground truth establishment by experts, MRMC studies, etc.) do not apply to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance tests conducted to demonstrate the safety and effectiveness of the contact lenses. The acceptance criteria are based on established standards for contact lens properties and safety.

Here's an interpretation based on the provided document, framed within the context of a traditional medical device submission, rather than an AI/ML algorithm:

Acceptance Criteria and Study for Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

The device, Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water), is a Class II medical device. Its acceptance criteria and proof of meeting them are primarily based on demonstrating substantial equivalence to legally marketed predicate devices through a combination of non-clinical (laboratory) testing and established material safety.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this contact lens device are derived from the performance characteristics of predicate devices and general industry standards for soft contact lenses. The reported device performance is compared against these benchmarks to demonstrate substantial equivalence.

Key Findings:

• The proposed device matches the material, water content, refractive index, visible light transmittance, and UV blocking properties of the predicate devices.
• The oxygen permeability of the proposed device ($23.2 \times 10^{-11}$) falls within the range and is comparable to the predicate devices ($20.6 \times 10^{-11}$ and $25 \times 10^{-11}$).
• The lens designs (Sphere, Asphere, Toric, Multifocal) are covered by the combined designs of the two predicate devices, demonstrating equivalence in functionality.
• The indications for use are also substantially equivalent to or within the scope of the predicate devices.

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

For this type of device (contact lenses), there isn't a "test set" in the common AI/ML sense (i.e., a dataset of images or patient records for algorithmic evaluation). Instead, the "testing" involves laboratory characterization of the physical and chemical properties of manufactured lenses.

• Sample Size: The document does not specify the exact sample sizes for each non-clinical test (e.g., how many lenses were tested for oxygen permeability). This information would typically be detailed in the full test reports referenced in the submission, conforming to relevant ISO standards or FDA guidance.
• Data Provenance: The tests are performed on samples of the manufactured Pegavision contact lenses themselves. The document states, "All tests were conducted in accordance with the May 1994 FDA guidance title Premarket Notification 510(K) Guidance Document for Class II Contact Lenses." This implies the testing was likely conducted in a controlled laboratory environment, presumably by the manufacturer or a contracted lab, with methodologies defined by regulatory guidance. The country of origin of the data is Taiwan, where Pegavision Corporation is located. The studies are prospective in the sense that they are specifically conducted to characterize the new device.

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

This concept is not applicable to this type of medical device submission. Ground truth for contact lenses is established through objective physical and chemical measurements (e.g., refractometers for refractive index, oxygen permeameters for oxygen permeability, spectrophotometers for light transmittance). There is no "expert consensus" on the "truth" of a lens's physical property; it's a direct measurement.

4. Adjudication Method for the Test Set

This concept is not applicable. Since the "ground truth" for the non-clinical tests is directly measured physical properties, there is no need for adjudication of human interpretations.

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 concept is not applicable. An MRMC study is a clinical study design used primarily for diagnostic devices, especially those involving human interpretation of medical images (e.g., radiologists reading X-rays). This submission is for a physical medical device (contact lenses), not an AI algorithm assisting human readers.

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

This concept is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to objectively measured physical and chemical properties of the contact lenses. This includes:

• Physicochemical Properties: Refractive Index, Oxygen Permeability, Water Content, Extractables, Mechanical Properties, Light Transmittance.
• Biocompatibility: Cytotoxicity, Ocular Irritation, Acute Systemic Toxicity (these tests assess the biological response to the material).
• Shelf Life and Sterility: Confirming the product's integrity and safety over time.

These are established through laboratory testing using validated methods and scientific instrumentation, not expert consensus or outcomes data in the typical sense of a diagnostic trial.

8. The Sample Size for the Training Set

This concept is not applicable. "Training set" is a term used in machine learning for data used to develop and optimize an algorithm. This submission is for a manufactured physical product, not an AI algorithm.

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

This concept is not applicable for the reasons stated above.

Summary regarding this specific submission (K222885):

The FDA's decision of substantial equivalence for these contact lenses is based on the following:

• Comparison to Predicate Devices: The proposed device uses the same USAN material (Hioxifilcon A) and has highly similar technological characteristics (water content, refractive index, UV blocking, oxygen permeability) to already cleared predicate devices.
• Non-Clinical Testing: The manufacturer performed standard non-clinical tests (physicochemical properties, biocompatibility, shelf life, sterility) in accordance with FDA guidance for Class II contact lenses. These tests demonstrated that the specific manufactured lenses meet safety and performance standards comparable to the predicates.
• No Clinical Study Required: Given the well-documented safety and effectiveness of the Hioxifilcon A material and the substantial equivalence to existing devices, the FDA deemed that clinical studies were "not required for the premarket notification." This is common for 510(k) submissions of well-understood device types with established predicates.

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Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Sphere designs are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and astigmatic corrections from -0.25 to -3.50 diopters.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition form +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses with Multifocal-Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters who may need up to +3.00 diopters of ADD power and have -3.50 diopters of astigmatism or less.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

The Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are clear, visibility-tinted, UV absorber-containing and are available in sphere, asphere, toric, multifocal and multifocal-toric designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) and 1,1,1-Trimethylolpropane Trimethacrylate (TMPTMA) and made by photo-polymerization. The lens consists of 42% Etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer further contains a benzotriazole, a UV absorbing monomer, thus is able to block the UV radiation to the ocular. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 315-380mm. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.

The provided document is a 510(k) premarket notification for Aquamax (Etafilcon A) soft contact lenses. It asserts substantial equivalence to existing predicate devices rather than presenting a novel device that requires a new clinical study with specific acceptance criteria and performance data. Therefore, the information typically requested regarding acceptance criteria, study design, and performance metrics for a new device's clinical efficacy is not present in this document.

Instead, the submission relies on the established safety and effectiveness of the predicate devices.

Here's an breakdown of the available information regarding testing:

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

This document does not provide a table of acceptance criteria for a new clinical study. Instead, it performed non-clinical tests to demonstrate that the proposed device is comparable to the predicate devices. The "Technological characteristics studies" table (page 8) presents a comparison of the proposed device's physical properties with those of the predicate devices.

Non-clinical tests performed (page 7) and their relevance to acceptance criteria:

• Physicochemical Properties Test: The results of this test would demonstrate that the lenses meet the established finished product specifications. The specific acceptance criteria are not detailed but are implied to be within acceptable ranges for contact lens safety and performance.
• Biocompatibility Tests (according to ISO 10993 series):
  • Cytotoxicity Test (ISO 10993-5): Proves the materials (lenses, packaging solution, plastic container) are not toxic to cells. Acceptance criteria would be no significant cytotoxic effect.
  • Ocular Irritation Test (ISO 10993-10): Proves the materials are not irritating to the eye. Acceptance criteria would be a low or absent irritation score.
  • Acute Systemic Toxicity Test (ISO 10993-11): Proves the materials do not cause acute systemic toxic effects. Acceptance criteria would be no significant systemic toxic response.
• Extractable Test: Demonstrates that leachable substances from the device are within safe limits. Acceptance criteria would be that extractables are below specified toxicological thresholds.
• Shelf Life Test and Sterility Test: Confirm the device maintains its properties and sterility over its intended shelf life. Acceptance criteria would include maintaining physical integrity, water content, and remaining sterile.

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

No specific sample size for a clinical "test set" is mentioned because a clinical study was not required for this 510(k) submission. The non-clinical tests (physicochemical, biocompatibility, extractable, shelf life, sterility) would have their own sample sizes for the materials tested, but these are not detailed in this summary. The data provenance is implied to be from internal testing by Pegavision Corporation, Taiwan, as they are the submitter. These appear to be laboratory-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. As no clinical study was required for this 510(k), there was no "test set" in the context of human data requiring expert ground truth establishment. Non-clinical tests are evaluated against scientific standards and regulations (e.g., ISO standards).

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

Not applicable, as no clinical study and corresponding test set requiring adjudication was performed.

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 tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

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

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

For the non-clinical tests, the "ground truth" is based on established scientific principles, regulatory standards (like ISO 10993), and the performance characteristics of the predicate devices. For example, for biocompatibility, the ground truth is an absence of toxicity or irritation defined by the standards. For material properties, it's the measured values compared against established ranges and predicate device data.

8. The sample size for the training set:

Not applicable. There is no training set in the context of an algorithm or AI.

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

Not applicable. There is no training set in the context of an algorithm or AI.

In summary:

This 510(k) submission for Aquamax contact lenses relies on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving the safety and effectiveness of a novel device through new clinical trials with defined acceptance criteria. The "study" referenced involves a series of non-clinical tests (physicochemical properties, biocompatibility, extractables, shelf life, sterility) to confirm that the new device's materials and manufacturing process yield a product with comparable characteristics and safety profiles to the predicates. The success of these non-clinical tests, along with the inherent similarity to established predicate devices, forms the basis for the FDA's substantial equivalence determination.

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Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with nondiseased eyes in powers from +6.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myoropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and astigmatic corrections from -0.25 to -3.50 diopters.

Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.

Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25diopters and astigmatic corrections from -0.25 to -3.50 diopters.

Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eve care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

The Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses are clear, visibility-tinted, UV absorber-containing and are available in spherical, aspherical, toric and multifocal designs. It is an ionic hydrogel lens derived from Etafilcon A material which is a co-polymer of 2-Hydroxyethyl Methacrylate (HEMA) and Methacrylic Acid (MAA), cross-linked with Ethylene Glycol Dimethacrylate (EGDMA) and 1,1,1-Trimethylolpropane Trimethacrylate (TMPTMA) and made by photo-polymerization. The lens consists of 42% Etafilcon A and 58% water by weight when immersed in buffered saline solution. The lens polymer further contains benzotriazole, a UV absorbing monomer, thus is able to block the UV radiation to the ocular. . The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 315-380mm. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR section 73.3121. Lenses are supplied sterile in the sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate, Polyethylene Glycol, and Cyanocobalamin as a color indicator to induce the package solution as pink color.

The provided document is a 510(k) premarket notification for Aquamax (Etafilcon A) contact lenses. It does not describe a study that involves an AI/ML device, nor does it contain information about acceptance criteria and reported device performance in the context of an AI/ML device.

The document discusses the substantial equivalence of the Aquamax contact lenses to previously cleared predicate devices based on non-clinical studies (physicochemical properties, biocompatibility, packaging solution, plastic container, extractable, shelf life, and sterility tests) and the fact that Etafilcon A lenses have been widely used and their safety/effectiveness well documented.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance for an AI/ML device from this document. The questions provided are specifically tailored for AI/ML device evaluations.

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Pegavision (Etafilcon A) Color SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 dioters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.25 to -3.50 diopters. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.50 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear.

Pegavision (Etafilcon A) Color SPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.25 to -3.50 diopters. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.50 to -12.25 diopters and with non-diseased eyes who may require a reading. addition from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The lens is available tinted and may be used to enhance or alter the apparent color of the eye.

Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses and Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal designs lenses. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. The contact lens color additives use FDA approved colorants and combination pigmented area that will mask or enhance the apparent color of the eyes.

These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 315-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80. Sodium Hyaluronate and Polyethylene Glycol.

The provided text contains information about the regulatory clearance of contact lenses, specifically Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses.

*However, the document does not describe an AI/ML-based device and therefore does not contain information about acceptance criteria, test sets, ground truth establishment, or clinical studies involving human readers and AI assistance for such a device.

Instead, it focuses on demonstrating substantial equivalence to predicate contact lenses through:

• Physicochemical Properties Tests: Measuring properties like water content, refractive index, oxygen permeability, and light transmittance.
• Biocompatibility Tests: Including cytotoxicity, maximization sensitization, and ocular irritation tests.
• Shelf Life Test and Sterility Test.
• Extractable Test.
• Compatibility Test of Care Solution.

The document explicitly states: "Clinical studies for Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses of the present device are not required for the premarket notification as the USAN name and process or color additive are the same as the above mentioned predicate devices." This indicates that the safety and effectiveness were established through non-clinical testing and comparison to already cleared devices, not through a clinical trial with human subjects/readers.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, test set details, ground truth, expert adjudication, or MRMC studies, as these concepts are not applicable to the content of the provided regulatory filing for contact lenses.

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1. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses:
   Spherical and Aspherical
   Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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 acuity.
   Toric
   Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in 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
   Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
   Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
2. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses:
   Spherical and Aspherical
   Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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
   Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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
   Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
   Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
   The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are available as spherical, aspherical, toric and multifocal lenses. The model illuminated with high water (58 %). These hydrogel lens materials are random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were crosslinked with glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane ethylene e trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5% in the UVB range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate and Polyethylene Glycol.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a full, detailed study report with all raw data. Therefore, some information, especially regarding detailed sample sizes for specific tests (like each biocompatibility test), expert qualifications, and adjudication methods, is not explicitly provided in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated for most tests in quantitative terms (e.g., number of lenses, number of animals). The document indicates "All tests were conducted" and "Studies were conducted to determine leachable materials," implying standard testing protocols were followed, which would inherently involve specific sample sizes per test type (e.g., for cytotoxicity, sensitization, ocular irritation, material property measurements) but these numbers are not detailed in this summary.
• Data Provenance: The studies were conducted by Pegavision Corporation (Taiwan). The report implies that these were internal studies to support the 510(k) submission. Therefore, it is retrospective in the sense that the data was generated to support the application, but the tests themselves would have been conducted prospectively on the device.

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

• This information is not provided in the summary. For non-clinical tests (biocompatibility, material characteristics, microbiology), "ground truth" is typically established by laboratory standards and validated methods rather than expert consensus on individual observations. For manufacturing verification, engineers and quality control personnel would assess against specifications.

4. Adjudication Method for the Test Set

• This information is not applicable in the context of these non-clinical, objective tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective assessments (e.g., image interpretation, patient-reported outcomes) from multiple readers or clinicians require reconciliation for ground truth establishment.

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, an MRMC comparative effectiveness study was not done.
• This device is a physical medical device (contact lenses), not an AI/software device that assists human readers. Therefore, this type of study is completely irrelevant to this submission.

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

• No, a standalone performance study was not done.
• As established above, this is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

• For the non-clinical tests described:
  • Material properties: Measured values compared against established standards and values of predicate devices.
  • Biocompatibility: Negative responses (absence of toxicity, sensitization, irritation) based on standardized in vitro and in vivo models.
  • Microbiology/Sterility: Achievement of a specified Sterility Assurance Level (SAL) confirmed by validation studies using microbiological indicators and established protocols.
  • Leachability: Absence of detectable levels of specific substances using analytical chemistry methods.
  • Manufacturing Verification: Conformance to engineering specifications and tolerances for physical dimensions (diameter, power, base curve).

8. The Sample Size for the Training Set

• Not applicable. This device is a manufactured product, not an AI model requiring a training set. The term "training set" is typically associated with machine learning and AI algorithms.

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

• Not applicable. See point 8.

Summary of the Study per the Document:

The study presented in this 510(k) summary is a series of non-clinical, laboratory-based tests designed to demonstrate the safety and effectiveness of the Aquamax (Etafilcon A) contact lenses and their substantial equivalence to legally marketed predicate devices. The "study" encompasses:

• Technological Characteristics Comparison: Direct comparison of material properties and design specifications with three predicate devices (K120028, K962804, K991134). The current device largely matches the most relevant predicate (K120028) for key properties like oxygen permeability and percentage transmission, and is in acceptable ranges for others.
• Biocompatibility Testing: According to standard cytotoxicity, maximization sensitization, and ocular irritation tests.
• Microbiology and Sterilization Validation: Validation of the steam sterilization process to ensure a minimum SAL of 10⁻⁵ and demonstration of sterility throughout the shelf life.
• Bacteriostatic Validation: Testing of the steam sterilizer's effectiveness in killing microorganisms.
• Leachability Studies: To confirm the absence of leachable monomers and additive residues.
• Manufacturing Verification Studies: For the new toric and multifocal lens designs, ensuring they meet specified tolerances for key parameters like diameter, power, and base curve.

The overarching "study" proves adherence to the "Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses" (May 1994) and establishes substantial equivalence based on these non-clinical tests. Clinical studies were deemed "not required" due to the well-documented safety and effectiveness of etafilcon A lenses and the similarity to predicate devices.

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1. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
   Spherical and Aspheric: Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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: Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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: Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. 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: Aquamax (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
   Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.
2. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement (Replacement Recommended Every 2 Weeks):
   Spherical and Aspheric: Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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: Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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: Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. 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: Aquamax (Etafilcon A) Multifocal Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
   Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. Pegavision recommends up to two week replacement for Etafilcon A lenses, or replacement as recommended by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
3. NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
   Spherical and Aspheric: NaturalVue (Etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or 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: NaturalVue (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or 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: NaturalVue (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. 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: NaturalVue (Etafilcon A)Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less.
   NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.

The Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and Natural/ue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses are clear or visibility-tinted, containing a UV blocker and are available in a spherical, aspherical multifocal, and multifocal toric designs. They are manufactured by cast molding method. The device is an ionic hydrogel lens derived from Etafilcon A which is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. The copolymer consists of 42% Etafilcon A and 58% water by weight when immersed in normal buffered saline solution. The lenses are tinted blue using C.I. Reactive Blue 19 to make them more visible for handling. The lenses contain a UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of the lenses are less than 5% in the UVB range of 280-315nm and less than 30% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.

This document is a 510(k) premarket notification for three types of soft contact lenses: Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, and NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate devices based on material properties, biocompatibility, microbiology, bacteriostatic validation, and leachability. There are no explicit quantitative acceptance criteria stated beyond "complying with the requirement of FDA Group 4" for sterilization. Differences in oxygen permeability and percent transmittance are evaluated against the predicate devices.

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

The document does not specify a "test set" in the context of a clinical study with a specific sample size. The evaluation relies heavily on non-clinical tests comparing the device's properties to legally marketed predicate devices.

• Data Provenance: The document explicitly states that "Aquamax (Etaflicon A) Soft (Hydrophilic) Contact Lenses from the previous FDA cleared K120028 did not require clinical studies as the USAN name and manufacturing processes are the same as the above-mentioned ACUVUE predicate (and reference) devices." This indicates a reliance on the historical performance and existing regulatory clearances of similar devices.
• Non-Clinical Tests: These tests would involve laboratory samples of the contact lenses. The specific number of contact lenses or batches tested for each non-clinical criterion (e.g., water content, Dk, transmittance, biocompatibility) is not provided. The provenance of these laboratory samples (e.g., country of manufacture) is implicitly Taiwan, where Pegavision Corporation is located. These would be retrospective in the sense that they are conducted on manufactured devices for regulatory submission, rather than a prospective clinical trial on human subjects.

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

This information is not applicable as there was no "test set" in the context of clinical data requiring expert review for ground truth. The evaluation is based on non-clinical laboratory testing and equivalence to predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

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 information is not applicable. This submission is for a medical device (contact lenses), not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as the device is a contact lens and not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by:

• Laboratory measurements/standards: For material properties (water content, Dk, transmittance, refractive index), biocompatibility (standard cytotoxicity, maximization, ocular irritation tests), microbiology (sterilization SAL), bacteriostatic validation, and leachability. These are objective, quantifiable measurements against established scientific and regulatory standards.
• Demonstrated equivalence to predicate devices: The "ground truth" for the overall safety and effectiveness is largely based on the fact that the proposed devices are substantially equivalent to previously cleared devices (K120028, K013445, K962804) which have established safety and effectiveness profiles through prior regulatory review and historical clinical use.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/machine learning model.

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

This information is not applicable as there is no training set.

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Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 D to -20.00 D. Eye practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. Lenses help protect against transmission of harmful UV radiation to the cornea and into the eve.

Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with water content of 38%. These hydrogel lens materials are homo-polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UV range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Aquamax (Polymacon) Soft (Hydrophilic) Contact Lenses:

The submission K123973 refers to a 510(k) premarket notification for contact lenses, which are inherently different from typical medical devices that might involve AI, image analysis, or complex algorithms requiring extensive performance criteria like sensitivity, specificity, or reader studies. This document, therefore, focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving performance against specific acceptance criteria for a novel technology.

As such, many of the requested categories (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable to this type of regulatory submission for contact lenses, which relies on the established safety and effectiveness of the material and manufacturing process. The "acceptance criteria" here are implicitly about matching the characteristics of the predicate devices and fulfilling non-clinical testing requirements.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are largely defined by its resemblance and comparable performance to the predicate devices. The study demonstrates substantial equivalence through a comparison of technological characteristics and non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details

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

• Sample size for test set: Not explicitly specified in terms of number of lenses or subjects. The document refers to "tests" conducted, implying a certain number of samples for each non-clinical test (e.g., biocompatibility, sterilization, leachability).
• Data provenance: Not specified, but generally refers to in-house laboratory testing based on FDA guidelines for non-clinical performance.

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

• Not Applicable. This is a non-clinical evaluation comparing material properties and safety characteristics, not a diagnostic device requiring expert interpretation for ground truth.

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

• Not Applicable. See point 3.

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 tool. No reader studies were conducted.

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:

• The "ground truth" here is based on established testing methodologies and standards for contact lens materials and safety. For instance:
  • Technological characteristics: Measured physical properties (e.g., water content, refractive index, oxygen permeability) against known values for the material (Polymacon) and predicate devices.
  • Biocompatibility: Results from standardized in vitro and in vivo animal model tests (cytotoxicity, sensitization, ocular irritation).
  • Microbiology/Sterilization: Validation against a sterility assurance level (SAL) of 10⁻⁶ using standard methods.
  • Leachability: Chemical analysis to detect leachable substances.

8. The sample size for the training set:

• Not Applicable. This device is a contact lens, not an AI-powered system that requires a "training set."

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

• Not Applicable. See point 8.

Summary of the Study:

The study presented in K123973 is a non-clinical study designed to demonstrate substantial equivalence of the Aquamax (Polymacon) Quarterly and Monthly Disposable Soft (Hydrophilic) Contact Lenses to two predicate devices: Soflens Multifocal (Polymacon) Visibility Tinted Contact lens (K020927) and Frequency 38 (Polymacon) Soft (hydrophilic) Contact Lens (K042824).

The study followed the May 1994 FDA guideline titled "Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses."

The proof of meeting "acceptance criteria" (i.e., substantial equivalence) is established by showing that the Aquamax lenses:

1. Share the same technological characteristics with the predicate devices (same FDA Group, USAN name (Polymacon), production method, water content, refractive index, power range, and comparable oxygen permeability and % T at 593 nm). The new lenses also include UV blocking properties.
2. Pass a series of non-clinical safety tests:
   • Biocompatibility: Negative responses for cytotoxicity, maximization sensitization, and ocular irritation.
   • Microbiology/Sterilization: Validation of steam sterilization process to achieve a minimum SAL of 10⁻⁶ and shelf-life stability.
   • Bacteriostatic Validation: Demonstration that microorganisms were killed and lens packages maintained sterility and integrity for a 5-year accelerated period.
   • Leachability: No detectable leachable monomers or additive residues.

The document explicitly states that clinical studies were "not required" because the USAN name (Polymacon) and manufacturing process are the same as the predicate devices, whose safety and effectiveness are "well documented." This approach is typical for 510(k) submissions of devices that are very similar to already cleared devices.

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